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Patient experiences of COVID-19-induced changes to methadone treatment in a large community-based opioid treatment program in Baltimore

Published:January 06, 2023DOI:https://doi.org/10.1016/j.josat.2022.208946

      Highlights

      • Responses to COVID-19 pandemic forced dramatic changes to OUD treatment regulations.
      • Regulation changes included increased take-home methadone (THM) and virtual meetings.
      • We explored patients’ experiences of the regulation changes on their treatment.
      • Findings revealed mixed experiences of THM and telebehavioral health meetings.
      • A more flexible and patient-centered approach to methadone dosing is warranted.

      Abstract

      Introduction

      Following the March 2020 federal declaration of a COVID-19 public health emergency, in line with recommendations for social distancing and decreased congregation, federal agencies issued sweeping regulation changes to facilitate access to medications for opioid use disorder (MOUD) treatment. These changes allowed patients new to treatment to receive multiple days of take-home medications (THM) and to use remote technology for treatment encounters—allowances that previously had been reserved exclusively for “stable” patients who met minimum adherence and time-in-treatment criteria. The impact of these changes on low-income, minoritized patients (frequently the largest recipients of opioid treatment program [OTP]-based addiction care), however, is not well characterized. We aimed to explore the experiences of patients who were enrolled in treatment prior to COVID-19 OTP regulation changes, with the goal of understanding patients' perceptions of the impact of these changes on treatment.

      Methods

      This study included semistructured, qualitative interviews with 28 patients. We used a purposeful sampling method to recruit individuals who were active in treatment just before COVID-19-related policy changes went into effect, and who were still in treatment several months later. To ensure a diverse array of perspectives, we interviewed individuals who either had or had not experienced challenges with methadone medication adherence from 3/24/21 to 6/8/21, approximately 12–15 months following the onset of COVID-19. Interviews were transcribed and coded using thematic analysis.

      Results

      Participants were majority male (57 %), Black/African American (57 %), with a mean age of 50.1 (SD = 9.3). Fifty percent received THM prior to COVID-19, which increased to 93 % during the pandemic. COVID-19 program changes had mixed effects on treatment and recovery experiences. Themes identified convenience, safety, and employment as reasons for preferring THM. Challenges included difficulty with managing/storing medications, experiencing isolation, and concern about relapse. Furthermore, some participants reported that telebehavioral health encounters felt less personal.

      Conclusions

      Policymakers should consider patients' perspectives to foster a more patient-centered approach to methadone dosing that is safe, flexible, and accommodating to a diverse array of patients' needs. Additionally, technical support should be provided to OTPs to ensure interpersonal connections are maintained in the patient-provider relationship beyond the pandemic.

      Keywords

      1. Introduction

      Methadone treatment (MT) is one of the most effective interventions for reducing the risk of overdose and mortality among people with opioid use disorder (OUD) (
      • Sordo L.
      • Barrio G.
      • Bravo M.J.
      • Indave B.I.
      • Degenhardt L.
      • Wiessing L.
      • Ferri M.
      • Pastor-Barriuso R.
      Mortality risk during and after opioid substitution treatment: Systematic review and meta-analysis of cohort studies.
      ). Retention in MT, however, is poor, with national estimates indicating <50 % retention at six months after treatment initiation (
      • Williams A.R.
      • Nunes E.V.
      • Bisaga A.
      • Levin F.R.
      • Olfson M.
      Development of a cascade of care for responding to the opioid epidemic.
      ). Past research has highlighted various factors that contribute to poor MT retention, including inadequate provider training and education in MT prescribing, MT-related societal stigma, and legal and regulatory barriers imposed on opioid treatment programs (OTPs;
      • National Academies of Sciences E.a.M.
      Medications for opioid use disorder save lives.
      ). Of these regulatory barriers, the most oft-cited challenge is the restriction on take-home methadone (THM) privileges for patients enrolled in OTPs (
      • Greenblatt A.D.
      • Magidson J.F.
      • Belcher A.M.
      • Gandhi D.
      • Weintraub E.
      Overdue for an overhaul: How opioid treatment programs can learn from COVID-19.
      ). Ostensibly placed to address concerns surrounding medication diversion and overdose (
      • Madden E.F.
      • Christian B.T.
      • Lagisetty P.A.
      • Ray B.R.
      • Sulzer S.H.
      Treatment provider perceptions of take-home methadone regulation before and during COVID-19.
      ), THM restriction forces patients to arrive daily to an OTP for observed dosing for several weeks or months following treatment initiation. Strict and inflexible dosing models may be particularly harmful to low-income, underserved, and other marginalized populations—the same populations of patients who fare worse in OUD treatment and have the poorest treatment retention and adherence outcomes (
      • Saloner B.
      • Lê Cook B.
      Blacks and hispanics are less likely than whites to complete addiction treatment, largely due to socioeconomic factors.
      ;
      • Stahler G.J.
      • Mennis J.
      Treatment outcome disparities for opioid users: Are there racial and ethnic differences in treatment completion across large US metropolitan areas?.
      ). Furthermore, these pre-COVID dosing models alienate patients who would benefit from a more flexible, person-centered approach to MOUD treatment (
      • Frank D.
      • Mateu-Gelabert P.
      • Perlman D.C.
      • Walters S.M.
      • Curran L.
      • Guarino H.
      “It’s like ‘liquid handcuffs”: The effects of take-home dosing policies on methadone maintenance treatment (MMT) patients' lives.
      ).
      On March 16, 2020, in the context of the spread of COVID-19 in the United States, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued emergency guidance easing restrictions on THM at OTPs (
      • Substance Abuse and Mental Health Services Administration (SAMHSA)
      Opioid Treatment Program (OTP) guidance.
      ). These changes allowed patients considered to be “less stable” to receive up to 14 days of THM and “more stable” patients up to 28 days of THM. Determinations of “stability” were left to the individual OTPs' discretion and could be based on several factors including urine toxicology screening results and appointment adherence. Recent research has found little indication of diversion resulting from this increased access to THM (
      • Brothers S.
      • Viera A.
      • Heimer R.
      Changes in methadone program practices and fatal methadone overdose rates in Connecticut during COVID-19.
      ;
      • Figgatt M.C.
      • Salazar Z.
      • Day E.
      • Vincent L.
      • Dasgupta N.
      Take-home dosing experiences among persons receiving methadone maintenance treatment during COVID-19.
      ), and no evidence of increased methadone-involved overdose deaths (
      • Jones C.M.
      • Compton W.M.
      • Han B.
      • Baldwin G.
      • Volkow N.D.
      Methadone-involved overdose deaths in the US before and after federal policy changes expanding take-home methadone doses from opioid treatment programs.
      ), suggesting that effective, patient-centered MOUD treatment can be provided without stringent dosing policies. In addition to loosening the restrictions on methadone dispensing, federal regulations also allowed for increased telehealth
      Telehealth is used as an all-inclusive term to describe remote meetings with any provider of OUD treatment, including clinicians and non-clinicians
      encounters, flexibility in the prescription of controlled substances for OUD treatment via telehealth, and relaxation of health insurance reimbursement regulations for telehealth services (;
      Federation of State Medical Boards
      U.S. states and territories modifying requirements for Telehealth in response to COVID-19.
      ). For methadone dispensing from OTPs, the relaxed regulations surrounding telehealth meant that the mandated behavioral aspects of MT (e.g., group and individual counseling requirements) were able to be conducted virtually during COVID-19.
      Generally, COVID-19 had a devastating impact on people with OUD. In the wake of the pandemic, several reports describe challenges accessing care (medical, MOUD, and harm reduction services) as well as the social isolation experienced by people with OUD (
      • Galarneau L.R.
      • Hilburt J.
      • O’Neill Z.R.
      • Buxton J.A.
      • Scheuermeyer F.X.
      • Dong K.
      • Kaczorowski J.
      • Orkin A.M.
      • Barbic S.P.
      • Bath M.
      • Moe J.
      • Miles I.
      • Tobin D.
      • Grier S.
      • Garrod E.
      • Kestler A.
      Experiences of people with opioid use disorder during the COVID-19 pandemic: A qualitative study.
      ;
      • Watson D.P.
      • Staton M.D.
      • Grella C.E.
      • Scott C.K.
      • Dennis M.L.
      Navigating intersecting public health crises: A qualitative study of people with opioid use disorders' experiences during the COVID-19 pandemic.
      ). The literature on patients' experiences of COVID-19-related changes to OUD treatment, however—including expanded access to THM and telehealth—has shown mixed findings. Several qualitative studies reported that some patients rapidly adapted to regulation changes and expressed high satisfaction with THM and telehealth services during the pandemic (
      • Hoffman K.A.
      • Foot C.
      • Levander X.A.
      • Cook R.
      • Terashima J.P.
      • McIlveen J.W.
      • Korthuis P.T.
      • McCarty D.
      Treatment retention, return to use, and recovery support following COVID-19 relaxation of methadone take-home dosing in two rural opioid treatment programs: A mixed methods analysis.
      ;
      • Levander X.A.
      • Hoffman K.A.
      • McIlveen J.W.
      • McCarty D.
      • Terashima J.P.
      • Korthuis P.T.
      Rural opioid treatment program patient perspectives on take-home methadone policy changes during COVID-19: A qualitative thematic analysis.
      ;
      • Saloner B.
      • Krawczyk N.
      • Solomon K.
      • Allen S.T.
      • Morris M.
      • Haney K.
      • Sherman S.G.
      Experiences with substance use disorder treatment during the COVID-19 pandemic: Findings from a multistate survey.
      ;
      • Sousa J.L.
      • Raja P.
      • Huskamp H.A.
      • Mehrotra A.
      • Busch A.B.
      • Barnett M.L.
      • Uscher-Pines L.
      Perspectives of patients receiving telemedicine services for opioid use disorder treatment: A qualitative analysis of user experiences.
      ;
      • Suen L.W.
      • Castellanos S.
      • Joshi N.
      • Satterwhite S.
      • Knight K.R.
      “The idea is to help people achieve greater success and liberty”: A qualitative study of expanded methadone take-home access in opioid use disorder treatment.
      ;
      • Sugarman D.E.
      • Busch A.B.
      • McHugh R.K.
      • Bogunovic O.J.
      • Trinh C.D.
      • Weiss R.D.
      • Greenfield S.F.
      Patients' perceptions of telehealth services for outpatient treatment of substance use disorders during the COVID-19 pandemic.
      ). Other reports, however, suggested that the regulation changes exacerbated existing inequities and structural barriers to OUD treatment (
      • Harris M.T.H.
      • Lambert A.M.
      • Maschke A.D.
      • Bagley S.M.
      • Walley A.Y.
      • Gunn C.M.
      “No home to take methadone to”: Experiences with addiction services during the COVID-19 pandemic among survivors of opioid overdose in Boston.
      ;
      • Hser Y.-I.
      • Ober A.J.
      • Dopp A.R.
      • Lin C.
      • Osterhage K.P.
      • Clingan S.E.
      • Mooney L.J.
      • Curtis M.E.
      • Marsch L.A.
      • McLeman B.
      • Hichborn E.
      • Lester L.S.
      • Baldwin L.-M.
      • Liu Y.
      • Jacobs P.
      • Saxon A.J.
      Is telemedicine the answer to rural expansion of medication treatment for opioid use disorder? Early experiences in the feasibility study phase of a National Drug Abuse Treatment Clinical Trials Network Trial.
      ;
      • Russell C.
      • Ali F.
      • Nafeh F.
      • Rehm J.
      • LeBlanc S.
      • Elton-Marshall T.
      Identifying the impacts of the COVID-19 pandemic on service access for people who use drugs (PWUD): A national qualitative study.
      ;
      • Kang A.W.
      • DeBritz A.A.
      • Hoadley A.
      • DelaCuesta C.
      • Walton M.
      • Hurley L.
      • Martin R.
      Barriers and poor telephone counseling experiences among patients receiving medication for opioid use disorders.
      ;
      • Watson D.P.
      • Staton M.D.
      • Grella C.E.
      • Scott C.K.
      • Dennis M.L.
      Navigating intersecting public health crises: A qualitative study of people with opioid use disorders' experiences during the COVID-19 pandemic.
      ).
      Overall, gaps in the literature remain regarding the patient experience of OTP regulation changes among individuals with variable MT adherence, especially those in predominantly low-income and racial/ethnic minoritized communities. Exploring the experience of these groups of individuals during the COVID-19 pandemic is critical considering that MT adherence is linked with lower rates of OUD-related overdose mortality and better treatment outcomes (
      • Parpouchi M.
      • Moniruzzaman A.
      • Rezansoff S.N.
      • Russolillo A.
      • Somers J.M.
      Characteristics of adherence to methadone maintenance treatment over a 15-year period among homeless adults experiencing mental illness.
      ;
      • Russolillo A.
      • Moniruzzaman A.
      • Somers J.M.
      Methadone maintenance treatment and mortality in people with criminal convictions: A population-based retrospective cohort study from Canada.
      ). Furthermore, racially minoritized and economically disadvantaged people experience less access to treatment (including telehealth) and higher rates of overdose mortality across the United States (
      • Gold J.A.
      • Wong K.K.
      • Szablewski C.M.
      • et al.
      Characteristics and Clinical Outcomes of Adult Patients Hospitalized with COVID-19 — Georgia, March 2020.
      ;
      • Alexander K.
      • Pogorzelska-Maziarz M.
      • Gerolamo A.
      • Hassen N.
      • Kelly E.L.
      • Rising K.L.
      The impact of COVID-19 on healthcare delivery for people who use opioids: A scoping review.
      ;
      • Centers for Disease Control and Prevention (CDC)
      Health equity considerations & racial & ethnic minority groups.
      ). It is important to understand experiences of methadone medication delivery among individuals engaged in care at OTPs, especially marginalized populations who experience the greatest barriers to accessing medications, and to use that data to inform policies regarding methadone dispensing (
      • Mitchell S.G.
      • Gryczynski J.
      • Schwartz R.P.
      • O’Grady K.E.
      • Olsen Y.K.
      • Jaffe J.H.
      A randomized trial of intensive outpatient (IOP) vs. standard outpatient (OP) buprenorphine treatment for African Americans.
      ;
      • Madras B.K.
      • Ahmad N.J.
      • Wen J.
      • Sharfstein J.
      • the Prevention and Recovery Working Group of the Action Collaborative on Countering the U.S. Opioid Epidemic, T.
      Improving access to evidence-based medical treatment for opioid use disorder: Strategies to address key barriers within the treatment system.
      ;
      • Parlier-Ahmad A.B.
      • Pugh M.
      • Martin C.E.
      Treatment outcomes among black adults receiving medication for opioid use disorder.
      ).
      The current study aimed to qualitatively explore 1) the experiences of patients with variable MT adherence regarding THM regulation changes at OTPs and 2) the experience of patients with telebehavioral
      Telebehavioral health is used to describe remote meetings between patients receiving OUD treatment and their counselors
      health meetings at an outpatient OTP in Baltimore City.

      2. Materials and methods

      Results are reported following the standards for reporting qualitative research (SRQR) guidelines.

      2.1 Study setting

      The University of Maryland, Baltimore's Institutional Review Board (HP-00093579) approved this study and all participants consented to participation in the study. The study took place at a community-based, outpatient OTP that serves a low-income population in West Baltimore, Maryland. A majority of the patient census identified as Black or African American and >80 % reported an annual income of less than $15,000. This center provides treatments for OUD that include methadone, buprenorphine, and naltrexone, as well as mental health services.

      2.1.1 Pre-COVID-19 OTP operations

      Pre-COVID-19, the clinic operated six days a week, providing in-person group and individual counseling and psychosocial services in addition to MOUD. Pre-COVID, take-home doses of methadone were provided according to SAMHSA guidelines for standard-of-care OUD treatment, determined by the medical director per eight criteria for take-home medication specified in federal regulations 42 CFR, Part 8, Subpart C § 8.12(i) (
      Substance Abuse and Mental Health Services Administration (SAMHSA)
      Medications for opioid use disorder. Treatment improvement protocol (TIP) series 63 HHS publication no. PEP21-02-01-002.
      ).

      2.1.2 OTP operations during COVID-19 lockdown

      At the onset of the COVID-19 pandemic (March 2020), the leadership substantially modified clinic operations to follow state and federal recommendations for social distancing, thereby decreasing the threat of disease communication. Specifically, the site took three major steps in the two weeks following the COVID-19 outbreak: (i) most (>95 %) of its 500+ patient census was converted to take-home methadone status; (ii) telehealth capacity was augmented, and a majority of the staff was converted to remote (work from home) status; and (iii) routine drug testing frequency was reduced from monthly to quarterly. Most patients who had been in the program for >1 month were given a minimum of 2 weeks of take-home doses. Telebehavioral meetings were instituted, with a reverse telehealth option such that patients could use a computer at the clinic to attend a video call. These procedures were substantially in-place until August 2021, when discussions began about how to slowly roll back the COVID-19 clinic procedures to allow for more in-person activities.

      2.2 Study participants

      Under an IRB-approved protocol, we conducted recruitment in the following manner: we obtained a list via the clinic's methadone dispensing system (Methasoft, Netalytics) of patients who had entered treatment at least one month before COVID-19-induced program changes (i.e., before February 15, 2020). We used a purposeful sampling method to recruit two groups of individuals: those who had experienced challenges with MT adherence, and those who had not experienced MT adherence challenges. We defined challenges with medication adherence as having missed two consecutive methadone dosing days between February 15, 2020, and February 15, 2021, resulting in a 50 % reduction in their methadone dosage, per clinic policy. Using these criteria, we identified 85 people as potentially eligible. To ensure that varied views regarding participants' meetings with counselors were captured, within this sample, at least one, but no more than three, participants were recruited from each of the clinic's 11 staff counselors' caseloads. Hence, of the 85 who met the eligibility criteria, we approached 30. Two declined to participate. Researchers approached patients in person on the day that they presented to the clinic for their scheduled medication and invited them to participate in the study. Patients who missed 30 consecutive daily methadone dosing days (constituting a program withdrawal per the OTP rules) were excluded from study participation, to ensure the sample contained participants with a single treatment episode during the COVID-19 pandemic. Patients expressing interest in being approached for voluntary study involvement had the study procedures explained to them, consented, and were scheduled for a subsequent interview. We based the planned sample size on the anticipated number needed to reach theoretical saturation. Recruitment remained open until 30 interviews had been conducted, or theoretical saturation had occurred, whichever occurred first. Study participants (N = 28) included 15 patients who were experiencing challenges and 13 patients who were not (see Table 1 for demographic data and patient characteristics). Participants received $25 compensation for their time and researchers limited interviews to a maximum duration of one hour.
      Table 1Participant demographics (N = 28) reflecting patient status on the day of the interview.
      All (N = 28)MT adherence challenges
      Challenges in treatment adherence, defined as missing two consecutive methadone dosing days between February 15, 2020, and February 15, 2021, resulting in a 50 % reduction in methadone dosage.
      (n = 13)
      No MT adherence challenges
      Challenges in treatment adherence, defined as missing two consecutive methadone dosing days between February 15, 2020, and February 15, 2021, resulting in a 50 % reduction in methadone dosage.
      (n = 15)
      Mean (SD)Mean (SD)Mean (SD)
      Age (years)50.07 (9.46)49.54 (7.83)50.53 (10.94)
      Time in treatment on the day of interview (years)4 (2.98)4 (3.58)4 (2.60)
      N (%)n (%)n (%)
      Gender
       Male16 (57.14)6 (46.15)10 (66.67)
       Female12 (42.85)7 (53.85)5 (33.33)
      Race/Ethnicity
       White11 (39.29)4 (30.77)7 (46.67)
       Black/African American16 (57.14)9 (69.23)7 (46.67)
       American Indian1 (3.57)01 (6.66)
       Hispanic/Latino000
      Level of Education
       <High School13 (46.43)8 (61.54)5 (33.33)
       ≥High school15 (53.57)5 (38.46)10 (66.67)
      Housing Status
       Housed25 (89.29)11 (84.62)14 (93.33)
       Unhoused3 (10.71)2 (15.38)1 (6.67)
      Employment Status
       Employed (part-time or full-time)9 (32.14)5 (38.46)4 (26.66)
       Retired/Disabled10 (35.72)3 (23.08)7 (46.67)
       Unemployed/Homemaker9 (32.14)5 (38.46)4 (26.66)
      Lifetime IV drug use18 (64.29)8 (61.54)10 (66.67)
      Injection drug use (30 days)9 (32.14)4 (30.77)5 (33.33)
      Illicit opioids use (30 days)15 (53.57)7 (53.85)8 (53.33)
      THM received (self-report)
       Pre-pandemic14 (50)6 (46.15)8 (53.33)
       Post-policy changes26 (92.86)12 (92.31)14 (93.33)
      UDT
       Opioid positive
      Includes Opiates and Fentanyl.
      15 (53.57)8 (61.54)7 (46.67)
       Other illicit drugs
      Includes Amphetamines, Benzodiazepines, Tetrahydrocannabinol (THC), and Cocaine.
      21 (75)12 (92.31)9 (60)
      UDT- Urine Drug Toxicology; at closest time point to interview (Mean = 22 days, SD = 26.4 days).
      a Challenges in treatment adherence, defined as missing two consecutive methadone dosing days between February 15, 2020, and February 15, 2021, resulting in a 50 % reduction in methadone dosage.
      b Includes Opiates and Fentanyl.
      c Includes Amphetamines, Benzodiazepines, Tetrahydrocannabinol (THC), and Cocaine.

      2.3 Data collection procedures

      2.3.1 Semi-structured interview

      All data collection took place between March 2021 and June 2021. The research team developed a semistructured qualitative interview guide designed to explore patients' thoughts and experiences of COVID-19 program-related changes to their OUD treatment. As an example, specific questions that the interviewer asked included, “How do you feel about getting more take-home bottles because of the COVID-19 pandemic?”; “How has having more take-home bottles affected your opioid use?”; “Could you describe how COVID-19 has affected your treatment here?” and “Which would you prefer- the in-person counseling sessions or over the phone?” The interviewer encouraged participants to expand on their answers by asking probing questions to elicit as in-depth responses as possible. For example, if a participant indicated that they received take-home bottles but did not explicitly describe how they felt about it, the interviewer followed up with a question asking what they liked or did not like about having more take-home bottles. Also, to elicit accurate responses regarding preference for in-person or telebehavioral health meetings, the interviewer asked probing questions regarding the similarities and differences of each variation of treatment delivery. Each interview lasted between 30 min to an hour and was audio-recorded and transcribed using Otter.AI software (
      • Liang S.
      • Fu Y.
      • Lau S.
      Otter.ai basic: Transcription software (version 2.3.75).
      ). The lead research coordinator (T.C.), a master's level member of the study team with qualifications and extensive experience in qualitative research, conducted all interviews. Following the initial transcription process by Otter.AI software, this same study team member methodically checked and cleaned all transcripts for accuracy. This individual had no relationship with study participants before conducting interviews and only interacted with participants for study assessments and coordination. This same research coordinator (T.C.) was involved in developing the interview guide and had prior training in qualitative interviewing, including asking open-ended questions, effective probes, and working with vulnerable patient populations. As recommended by
      • Pope C.
      • Mays N.
      Qualitative methods in health research.
      , the research team transcribed interviews in real-time (within 48 h of the interview); recruitment and interviewing of participants continued until theoretical saturation was determined. See Supplementary Material 1 for the interview guide.

      2.3.2 Urine toxicology

      The study also obtained a HIPAA authorization to conduct a chart review of participants' EHR in Methasoft, including collecting urine toxicology data for each participant. Before the onset of the pandemic, the OTP assessed urine toxicology routinely (on average, once a month) for eight substances, including methadone, amphetamines, benzodiazepines, cannabinoid, cocaine, opiates, oxycodone/oxymorphone, and fentanyl. Due to COVID-19, the OTP reduced screening frequencies for all patients; however, urine toxicology screens still included the eight substances that were screened for before the onset of the pandemic. Hence, we collected the most recent urine toxicology data (i.e., the closest available test to the interview date) for each participant.

      2.4 Data analysis

      Due to the rapid and temporary switch to more flexible dosing schedules and the potential impact of the changes on patients' experience, we deemed the use of a rapid qualitative analysis approach that has been tested and described by
      • Gale R.C.
      • Wu J.
      • Erhardt T.
      • Bounthavong M.
      • Reardon C.M.
      • Damschroder L.J.
      • Midboe A.M.
      Comparison of rapid vs in-depth qualitative analytic methods from a process evaluation of academic detailing in the Veterans Health Administration.
      to be appropriate for this study. The rapid analysis focused on our main research questions around exploring the patient experience of COVID-19-induced changes to MT delivery. We developed a preliminary codebook following the eighth interview. Two members of the study team separately conducted this interim analysis: the lead research coordinator (T.C., who had also conducted the interviews), and a master's level research assistant (E.M.). The research team met as a group to evaluate the preliminary findings and to discuss whether any changes to the interview guide were warranted. After reaching a consensus that no further changes were needed to the interview guide, we continued recruitment until the study achieved theoretical saturation. As is standard practice for qualitative research methods (
      • Fusch P.
      • Ness L.
      Are we there yet? Data saturation in qualitative research.
      ;
      • Guest G.
      • Bunce A.
      • Johnson L.
      How many interviews are enough?: An experiment with data saturation and variability.
      ), our threshold for theoretical saturation was that the researchers were learning no new information from additional interviews. Data collection concluded after we conducted and analyzed 28 interviews and the study team determined that it had reached theoretical saturation on the primary study aims. Full coding of the transcripts was done by the lead research coordinator (T.C.) and two master's-level research assistants (E.M., T.A.), who iteratively created and adapted a codebook based on themes and subthemes that emerged from interviews. Initial coding was deductive based on primary study aims and specific questions in the interview guide to examine patients' experiences of relaxed COVID-19 restrictions and THM specifically; however, we also used inductive approaches to allow new themes to emerge from the data (
      • Bradley E.H.
      • Curry L.A.
      • Devers K.J.
      Qualitative data analysis for health services research: Developing taxonomy, themes, and theory.
      ). Transcripts were split between two coders, with each transcript assigned to one coder. The lead coder (T.C.) checked each coded transcript for accuracy and discrepancies in coding were resolved by consulting a senior member of the study team who served as arbiter. Researchers initially conducted coding in Excel to create the master codebook and subsequently managed data with Nvivo (released in March 2020). The codebook was updated iteratively with input from the coding team to reflect new themes and subthemes that emerged (
      • Boyatzis R.E.
      Transforming qualitative information: Thematic analysis and code development.
      ). The coding team met weekly to discuss findings and outstanding questions as well as any discrepancies. See Supplementary Material 2 for a summary of the data collection and analysis process using the Standards for Reporting Qualitative Research (SRQR) checklist.

      3. Results

      Fifty-seven percent of participants were male, 57 % identified as Black/African American, and had a mean age of 50.1 (SD = 9.3). Qualitative findings indicated that COVID-19 program changes had mixed effects on treatment and recovery experience in both the group that experienced MT challenges and those that did not. Three main themes emerged from patient interviews, and are presented in order of endorsement frequency (from highest to lowest): (i) the positive impacts of THM, (ii) the negative impacts of THM, and (iii) patients' experiences with telebehavioral health meetings. See Table 2 for the relationship between codes and themes.
      Table 2The relationship between codes and broader themes.
      CodeThemeSubthemes
      How do you feel about getting more take homes because of COVID-19?

      • -
        What do you like about having more take-home bottles?
      Positive impacts of THMConvenience of THM
      Employment autonomy
      Can you describe how COVID-19 has affected your treatment here at 1001?Navigating environmental barriers
      How have COVID-19 program changes affected your recovery?Take-home doses reflected success in recovery
      If you were able to choose, would you continue to receive more take-home bottles or go back to more infrequent in-person dosing?
      Can you describe how COVID-19 has affected your treatment here at 1001?Negative impacts of THMTough to manage THM
      How do you feel about getting more take homes because of COVID-19?

      • -
        What do you not like about having more take-home bottles?
      Has the COVID-19 pandemic impacted your opioid use?Mental health
      How have COVID-19 program changes affected your recovery?
      How has having more take-home bottles affected your opioid use?Challenges storing THM
      If you were able to choose, would you continue to receive more take-home bottles or go back to more infrequent in-person dosing?
      How was your relationship with staff the clinic staff been since you started seeing them in person less frequently?Patients’ experiences with telebehavioral health meetingsExisting counseling topics were maintained
      Which would you prefer the in-person counseling sessions or over the phone?

      • -
        How was this different from your in-person counselor meetings?
      • -
        How was this the same as your in-person counselor meetings?
      Less personal

      3.1 Positive impacts of THM

      3.1.1 Convenience of THM

      When asked about the impact of the COVID-19-related program changes (especially THM) on their experience at the OTP, many participants shared that being able to take their methadone on their own time helped them to balance other responsibilities. One participant shared:“It is convenient not having to come down here every day and not having to [be] working my schedule around it” [Pt 17, black male, five years in treatment, no MT adherence challenges]Participants talked about the fact that they did not have to contend with strict MOUD dosing times or struggle with balancing other appointments or activities to accommodate an OTP visit for observed dosing.“I liked it because I only had to come once a month. So, it was more convenient for me. Also, you know, not having to come out as often, because I might have [doctor] appointments, you know, I have my [psychosocial support] groups and stuff to do like that. So, it was really convenient.” [Pt 15, black female, three years in treatment, no MT adherence challenges]

      3.1.2 Employment autonomy

      Pre-pandemic, the operating hours of the clinic contributed to difficulties for working patients. Participants described the positive impact that THM had on their employment:“it's [THM] more convenient, and it lets me do my job” [Pt 26, black female, two years in treatment, MT adherence challenges].
      One participant contrasted their experience with THM to daily dosing:“I don't have to run in here before work... I know [that now] I'll be checking in on time at work. Nothings gonna hold me up.” [Pt 9, white female, one year in treatment, no MT adherence challenges]Another participant described their experience with managing side jobs and daily dosing:“I don't have like a full-time job, but I do a lot of side jobs. And sometimes it really interferes like running in here and then to my job. You have to hurry up, make it there in time, you know. Sometimes I come here before they open to get doses early so, I can make it to my job that day. So, I'm literally out there like waiting for the doors to open, you know, just to try to get to work on time.” [Pt 14, white male, one year in treatment, MT adherence challenges]

      3.1.3 Navigating environmental barriers

      Participants noted that increased THM decreased the amount of time they spent traveling to and from the clinic. The time saved by reducing commuting time opened new opportunities for patients to spend time at work or engage in other valued activities, including travel. One participant shared:“I live 20 minutes away [from the clinic]. I come down twice a week now. And it's a pain in the butt when [my boyfriend] only has to come once every two weeks. Having [take-homes], you can get a job easier. If you want to go to the beach, you can...” [Pt 23, white female, two years in treatment, no MT adherence challenges]Participants reported increases in personal time and routines due to the reduction in time spent commuting to the clinic, particularly through public transportation.“I like it because I could just get up in the morning and take my dose at seven o'clock in the morning and drink a cup of coffee and I don't have to travel on the bus.” [Pt 22, white male, two years in treatment, no MT adherence challenges]Some participants also shared that they experienced fewer triggers to use drugs than they would have otherwise encountered traveling to and from the clinic when they had their medications at home with them. One participant shared:“I mean, I didn't have to worry about getting up going to get drugs. It [the take-home medication] was right there. Sometimes when I come down here [to the clinic] I get side-tracked, you know, and I wind up getting some drugs. But since I had [the take-homes] right there with me I would just wake up and not have to worry about no drugs... I don't have to come down here through the triggers on the street.” [Pt 20, black male, one year in treatment, MT adherence challenges]

      3.1.4 Take-home doses reflected success in recovery

      Participants expressed the notion that take-home doses were symbolic of successful recovery. One patient described this as showing them they were “on the right track.” [Pt 15, black female, three years in treatment, no MT adherence challenges]. Having THM was described as reassuring:“It [receiving THM] would reassure me, hey you must be doing real good [with my recovery]”. [Pt 12, black male, three years in treatment, no MT adherence challenges]Take-home bottles can both encourage patients to continue doing well (not using substances or missing appointments), to keep something that they associate as a positive marker of their recovery process:“It's been positive for me because I don't want to lose them. I know they can take them away now and everything so I realize how much of an inconvenience that was coming here every day.” [Pt 16, white female, five years in treatment, no MT adherence challenges]The symbolism of the THM on the process of recovery was also noted as a negative impact when THM was taken away. One participant described their recent termination of take-home bottles, saying “it gave me time to really acknowledge where I really messed up” [Pt 04, black female, one year in treatment, MT adherence challenges]. Having had take-home medication made an impact on that person's experience and incentivized their commitment after a setback.

      3.2 Negative impacts of THM

      3.2.1 Tough to manage THM

      While several participants reported positive impacts of the COVID-induced OTP program changes, some individuals experienced significant challenges managing their dosing based on the quantity of THM doses they received. One participant said:“Having a lot of bottles throws everything off for me. I'd rather have a constructive... way of coming in here every day and eventually getting just six bottles.” [Pt 2, white male, ten years in treatment, no MT adherence challenges]Many shared that they welcomed the increase in THM initially, but after a while, it was overwhelming to manage their medications. One participant shared:“At first, I was happy about it. But then it was real hard to deal with all those bottles at once. I had to get adjusted to dealing with so many bottles....” [Pt 11, black male, eight years in treatment, no MT adherence challenges]One participant shared that they had to entrust someone else with managing their THM to reduce the temptation to misuse their methadone medication:“I'll be honest with you, at first, I had my boyfriend holding onto them. He put them in a separate room, so I didn't know they were there. Because I mean, I'm an addict. And it's hard for me.” [Pt 23, white female, two years in treatment, no MT adherence challenges]

      3.2.2 Mental health

      The COVID-19 pandemic brought about social isolation for many who routinely thrived on interpersonal interaction in their daily lives. Expounding on what social isolation during the pandemic meant to them, a participant shared:“No, well, I've missed coming in interacting with some of my peers and the staff, like, sometimes when I come in, I will go upstairs to the drop-in center [at the OTP], you know, and sit and talk and find out what's going on, you know...So I've been sad about that.” [Pt 15, black female, three years in treatment, no MT adherence challenges]In addition to being difficult to manage, some participants shared that having increased access to THM coupled with life stressors contributed to their relapse. One person talked about the mental health impacts of the pandemic being so troubling that they self-medicated with methadone and relapsed on other drugs. However, they shared a determination to get back on track with treatment, saying:“...if I don't feel good or something upset me, so I'll drink a half of a [take-home] bottle. So, in the long run, I'll run out before I come back here, and then that made me relapse... it's very embarrassing to relapse after all these years and that's what's motivating me to get my act together.” [Pt 2, white male, ten years in treatment, no MT adherence challenges]

      3.2.3 Challenges storing THM

      Among the participants in this study were those who were experiencing homelessness or were unstably housed. This group of individuals preferred daily methadone dosing, citing challenges in storing their medications safely. One participant shared that they, “...worry about them [THM] getting stolen...so I'd really just rather come in every day...It's happened twice now.” [Pt 8, white male, one year in treatment, MT adherence challenges].
      Another shared their frustration about repeated theft of their THM, and after multiple reports to law enforcement they opted to revert to daily dosing because of their unhoused status:“I ended up getting about two weeks' worth. It was good all the way up until they started getting stolen...After the second time they got stolen, because I'm homeless, the police kind of look at you like, yeah sure. So, I was like, put me on daily dosing, I'm done.” [Pt 29, white male, nine years in treatment, MT adherence challenges]

      3.3 Experience with telebehavioral health meetings

      3.3.1 Existing counseling topics were maintained

      Despite the telebehavioral health meetings, some participants shared that they were able to maintain the same interpersonal connection with their counselor as before the pandemic. Specifically, one participant shared that the OTP changes did not disrupt usual communication with their counselor, saying:“...we still talked about some of the same stuff that we talked about [pre-pandemic]. It wasn't nothing different.” [Pt 3, black male, two years in treatment, MT adherence challenges]One participant talked about how they appreciated that their counselor's flexibility, care, and attention to detail carried through even during telebehavioral health encounters, saying:“She's really good. She's pretty precise and really good with me. We went over the same stuff we go over in person. She tries to cover all the bases. She asks about my routine, if things are changing for the good or bad.” [Pt 21, white female, two years in treatment, MT adherence challenges]

      3.3.2 Less personal

      While some participants had positive experiences with counselor meetings, several did not. Participants talked about the loss of interpersonal connection with their counselor, saying:“It's just not as familiar. You're not able to really touch on anything personal.You just have to take care of business.” [Pt 11, black male, eight years in treatment, no MT adherence challenges]One person shared that despite having a good relationship with their counselor, they felt that they could not share everything during telebehavioral health meetings like they would have in person, saying:“For me over the phone was just a little less personal...I think me and my counselor have a good [rapport]. So, I'd like to see her because we laugh when we talk, you know, when I share stuff with her. I'd rather do that in person rather than over the phone and definitely not in a text.” [Pt 15, black female, three years in treatment, no MT adherence challenges]Another participant shared that they thought that it was not possible to get the full attention of their counselor during telebehavioral health meetings, saying:“...For me, I think in person is more personal. You can see the person's reaction, you can see the response that you're getting, and I think it's more attentive. It's [over the phone] completely different because I'm feeling that it's not as attentive.” [Pt 9, white female, one year in treatment, no MT adherence challenges]

      4. Discussion

      This study sought to qualitatively examine the impact of COVID-19 response-related OTP program changes on the experiences of patients at an OTP in Baltimore City that provides MOUD to a largely racial/ethnic minoritized population. Importantly, to ensure a diverse range of patient experiences, we captured the perspectives of patients who were well engaged and those who were not well engaged in treatment at the OTP (as defined by medication adherence). Findings demonstrated mixed effects of COVID-19 program changes on patients' experiences. While most participants reported a preference for increased THM to minimize COVID-19 infection risk and balance life responsibilities—citing benefits such as convenience, safety, and reduced interference with employment—others noted challenges with their mental health, as well as the difficulty they experienced in managing or storing their take-home medications. Furthermore, when describing the shift from in-person to telebehavioral health meetings, some participants reported that the structure and content of calls did not vary from the in-person format; however, these encounters felt less personal.
      Existing studies reinforce our findings (
      • Frank D.
      • Mateu-Gelabert P.
      • Perlman D.C.
      • Walters S.M.
      • Curran L.
      • Guarino H.
      “It’s like ‘liquid handcuffs”: The effects of take-home dosing policies on methadone maintenance treatment (MMT) patients' lives.
      ;
      • Nobles A.L.
      • Johnson D.C.
      • Leas E.C.
      • Goodman-Meza D.
      • Zúñiga M.L.
      • Ziedonis D.
      • Strathdee S.A.
      • Ayers J.W.
      Characterizing self-reports of self-identified patient experiences with methadone maintenance treatment on an online community during COVID-19.
      ), describing the negative impact of strict THM policies on the experiences of people receiving methadone medication at OTPs from the provider point of view. Research has found that the inflexible approach to methadone dispensing poses a significant barrier to patients' lives, including affecting their ability to maintain employment, travel, and meet other personal obligations (
      • Frank D.
      • Mateu-Gelabert P.
      • Perlman D.C.
      • Walters S.M.
      • Curran L.
      • Guarino H.
      “It’s like ‘liquid handcuffs”: The effects of take-home dosing policies on methadone maintenance treatment (MMT) patients' lives.
      ;
      • Nobles A.L.
      • Johnson D.C.
      • Leas E.C.
      • Goodman-Meza D.
      • Zúñiga M.L.
      • Ziedonis D.
      • Strathdee S.A.
      • Ayers J.W.
      Characterizing self-reports of self-identified patient experiences with methadone maintenance treatment on an online community during COVID-19.
      ). In particular,
      • Frank D.
      • Mateu-Gelabert P.
      • Perlman D.C.
      • Walters S.M.
      • Curran L.
      • Guarino H.
      “It’s like ‘liquid handcuffs”: The effects of take-home dosing policies on methadone maintenance treatment (MMT) patients' lives.
      suggest that restrictive THM policies precipitate treatment discontinuation and discourage people who use drugs from engaging in MT. This suggestion is corroborated by our finding that for some patients, the receipt of THM represented a significant milestone in their recovery, and was also viewed as an indicator of success in MT (
      • Hoffman K.A.
      • Foot C.
      • Levander X.A.
      • Cook R.
      • Terashima J.P.
      • McIlveen J.W.
      • Korthuis P.T.
      • McCarty D.
      Treatment retention, return to use, and recovery support following COVID-19 relaxation of methadone take-home dosing in two rural opioid treatment programs: A mixed methods analysis.
      ;
      • Levander X.A.
      • Hoffman K.A.
      • McIlveen J.W.
      • McCarty D.
      • Terashima J.P.
      • Korthuis P.T.
      Rural opioid treatment program patient perspectives on take-home methadone policy changes during COVID-19: A qualitative thematic analysis.
      ;
      • Suen L.W.
      • Castellanos S.
      • Joshi N.
      • Satterwhite S.
      • Knight K.R.
      “The idea is to help people achieve greater success and liberty”: A qualitative study of expanded methadone take-home access in opioid use disorder treatment.
      ). Restrictive THM policies narrowly define success based on toxicology results, but that does not consider a patient's own definition of doing well. OTPs risk marginalizing and alienating patients from lifesaving OUD medications when the conditions to receive THM at OTPs are stringent and not patient-centered. Our findings provide additional insights on how patients who had or had not experienced MT adherence challenges before the onset of the COVID-19 pandemic adapted to COVID-19-related policy changes, and expands on the findings of other studies regarding largely positive (
      • Hoffman K.A.
      • Foot C.
      • Levander X.A.
      • Cook R.
      • Terashima J.P.
      • McIlveen J.W.
      • Korthuis P.T.
      • McCarty D.
      Treatment retention, return to use, and recovery support following COVID-19 relaxation of methadone take-home dosing in two rural opioid treatment programs: A mixed methods analysis.
      ;
      • Levander X.A.
      • Hoffman K.A.
      • McIlveen J.W.
      • McCarty D.
      • Terashima J.P.
      • Korthuis P.T.
      Rural opioid treatment program patient perspectives on take-home methadone policy changes during COVID-19: A qualitative thematic analysis.
      ;
      • Suen L.W.
      • Castellanos S.
      • Joshi N.
      • Satterwhite S.
      • Knight K.R.
      “The idea is to help people achieve greater success and liberty”: A qualitative study of expanded methadone take-home access in opioid use disorder treatment.
      ) and negative (
      • Harris M.T.H.
      • Lambert A.M.
      • Maschke A.D.
      • Bagley S.M.
      • Walley A.Y.
      • Gunn C.M.
      “No home to take methadone to”: Experiences with addiction services during the COVID-19 pandemic among survivors of opioid overdose in Boston.
      ;
      • Russell C.
      • Ali F.
      • Nafeh F.
      • Rehm J.
      • LeBlanc S.
      • Elton-Marshall T.
      Identifying the impacts of the COVID-19 pandemic on service access for people who use drugs (PWUD): A national qualitative study.
      ;
      • Watson D.P.
      • Staton M.D.
      • Grella C.E.
      • Scott C.K.
      • Dennis M.L.
      Navigating intersecting public health crises: A qualitative study of people with opioid use disorders' experiences during the COVID-19 pandemic.
      ) patient experiences of COVID-19-induced OTP regulation changes. Taken together, both providers' and patients' opinions of COVID-19-related regulation changes at OTPs suggest a need to incorporate the flexibilities of methadone dispensing into permanent policies beyond the acute phase of the COVID-19 pandemic to allow for an individualized approach to providing MT (
      • Hoffman K.A.
      • Foot C.
      • Levander X.A.
      • Cook R.
      • Terashima J.P.
      • McIlveen J.W.
      • Korthuis P.T.
      • McCarty D.
      Treatment retention, return to use, and recovery support following COVID-19 relaxation of methadone take-home dosing in two rural opioid treatment programs: A mixed methods analysis.
      ;
      • Treitler P.C.
      • Bowden C.F.
      • Lloyd J.
      • Enich M.
      • Nyaku A.N.
      • Crystal S.
      Perspectives of opioid use disorder treatment providers during COVID-19: Adapting to flexibilities and sustaining reforms.
      ).
      Although it was not an original goal of our study to compare demographics or key characteristics as contributors to the thematic differences found across the two groups of participants (challenges v. no challenges in treatment), we did not observe any alignment in participants' responses regarding THM or other COVID-19 program changes with patient characteristics such as MT adherence (challenges v. no challenges in treatment). Themes arising from this study showed that the “mixed effects” of program changes on patients' treatment experiences and preferences seemed to be at the individual level, suggesting a need to adopt patient-centered approaches to MT. While it is important to ensure access to THM for patients who can successfully manage their medication, OTPs should provide continued support to those who require more structure in their treatment (
      • Harris M.T.H.
      • Lambert A.M.
      • Maschke A.D.
      • Bagley S.M.
      • Walley A.Y.
      • Gunn C.M.
      “No home to take methadone to”: Experiences with addiction services during the COVID-19 pandemic among survivors of opioid overdose in Boston.
      ;
      • Madden E.F.
      • Christian B.T.
      • Lagisetty P.A.
      • Ray B.R.
      • Sulzer S.H.
      Treatment provider perceptions of take-home methadone regulation before and during COVID-19.
      ;
      • Russell C.
      • Ali F.
      • Nafeh F.
      • Rehm J.
      • LeBlanc S.
      • Elton-Marshall T.
      Identifying the impacts of the COVID-19 pandemic on service access for people who use drugs (PWUD): A national qualitative study.
      ;
      • Watson D.P.
      • Staton M.D.
      • Grella C.E.
      • Scott C.K.
      • Dennis M.L.
      Navigating intersecting public health crises: A qualitative study of people with opioid use disorders' experiences during the COVID-19 pandemic.
      ). This support could be crucial for individuals who experience social isolation, unstable housing, and those with co-occurring medical problems who need regular contact and support from their treatment team. Furthermore, providers should support and not appear to “punish” patients who begin to struggle with MT adherence, especially after long periods of successful engagement in treatment. Our findings show that, for some patients, the experience of receiving THM served as a strong motivator for behavior change that would allow them to maintain THM received as a result of COVID-related program changes; for example, by decreasing substance use. Essentially, patients should be empowered to take responsibility for their health and make necessary changes—with the support of their treatment team—to improve their health outcomes (
      • Scholl I.
      • Zill J.M.
      • Härter M.
      • Dirmaier J.
      An integrative model of patient-centeredness – A systematic review and concept analysis.
      ). Patient empowerment at OTPs should start by implementing intake processes that account for each individual's unique needs and treatment preferences (
      • Mark T.L.
      • Hinde J.
      • Henretty K.
      • Padwa H.
      • Treiman K.
      How patient centered are addiction treatment intake processes?.
      ). A one-size-fits-all approach to MT delivery is bound to push patients to discontinue treatment, is likely to diminish patient satisfaction, and impact the effectiveness of methadone as an evidence-based treatment (
      • Frank D.
      • Mateu-Gelabert P.
      • Perlman D.C.
      • Walters S.M.
      • Curran L.
      • Guarino H.
      “It’s like ‘liquid handcuffs”: The effects of take-home dosing policies on methadone maintenance treatment (MMT) patients' lives.
      ). Additionally, patient-centered and shared decision approaches that increase autonomy in the treatment process produce better treatment outcomes (
      • Marchand K.
      • Beaumont S.
      • Westfall J.
      • MacDonald S.
      • Harrison S.
      • Marsh D.C.
      • Schechter M.T.
      • Oviedo-Joekes E.
      Conceptualizing patient-centered care for substance use disorder treatment: Findings from a systematic scoping review.
      ;
      • Stacey D.
      • Légaré F.
      • Lewis K.
      • Barry M.
      • Bennett C.
      • Eden K.
      • Holmes-Rovner M.
      • Llewellyn-Thomas H.
      • Lyddiatt A.
      • Thomson R.
      • amp
      • et al.
      Decision aids for people facing health treatment or screening decisions.
      ).
      Similar to findings from other groups (
      • Hser Y.-I.
      • Ober A.J.
      • Dopp A.R.
      • Lin C.
      • Osterhage K.P.
      • Clingan S.E.
      • Mooney L.J.
      • Curtis M.E.
      • Marsch L.A.
      • McLeman B.
      • Hichborn E.
      • Lester L.S.
      • Baldwin L.-M.
      • Liu Y.
      • Jacobs P.
      • Saxon A.J.
      Is telemedicine the answer to rural expansion of medication treatment for opioid use disorder? Early experiences in the feasibility study phase of a National Drug Abuse Treatment Clinical Trials Network Trial.
      ;
      • Kang A.W.
      • DeBritz A.A.
      • Hoadley A.
      • DelaCuesta C.
      • Walton M.
      • Hurley L.
      • Martin R.
      Barriers and poor telephone counseling experiences among patients receiving medication for opioid use disorders.
      ;
      • Russell C.
      • Ali F.
      • Nafeh F.
      • Rehm J.
      • LeBlanc S.
      • Elton-Marshall T.
      Identifying the impacts of the COVID-19 pandemic on service access for people who use drugs (PWUD): A national qualitative study.
      ;
      • Saloner B.
      • Krawczyk N.
      • Solomon K.
      • Allen S.T.
      • Morris M.
      • Haney K.
      • Sherman S.G.
      Experiences with substance use disorder treatment during the COVID-19 pandemic: Findings from a multistate survey.
      ;
      • Sousa J.L.
      • Raja P.
      • Huskamp H.A.
      • Mehrotra A.
      • Busch A.B.
      • Barnett M.L.
      • Uscher-Pines L.
      Perspectives of patients receiving telemedicine services for opioid use disorder treatment: A qualitative analysis of user experiences.
      ;
      • Sugarman D.E.
      • Busch A.B.
      • McHugh R.K.
      • Bogunovic O.J.
      • Trinh C.D.
      • Weiss R.D.
      • Greenfield S.F.
      Patients' perceptions of telehealth services for outpatient treatment of substance use disorders during the COVID-19 pandemic.
      ), the rapid transition to telebehavioral health elicited mixed reactions from study participants. Some participants in our study described this transition as allowing them to maintain regular communication with their counselors, in line with positive views of telebehavioral health described by other people receiving MOUD (including methadone) and therapy—in similar settings and with similar demographics as the participants in this study (
      • Saloner B.
      • Krawczyk N.
      • Solomon K.
      • Allen S.T.
      • Morris M.
      • Haney K.
      • Sherman S.G.
      Experiences with substance use disorder treatment during the COVID-19 pandemic: Findings from a multistate survey.
      ;
      • Sousa J.L.
      • Raja P.
      • Huskamp H.A.
      • Mehrotra A.
      • Busch A.B.
      • Barnett M.L.
      • Uscher-Pines L.
      Perspectives of patients receiving telemedicine services for opioid use disorder treatment: A qualitative analysis of user experiences.
      ;
      • Sugarman D.E.
      • Busch A.B.
      • McHugh R.K.
      • Bogunovic O.J.
      • Trinh C.D.
      • Weiss R.D.
      • Greenfield S.F.
      Patients' perceptions of telehealth services for outpatient treatment of substance use disorders during the COVID-19 pandemic.
      ). On the other hand, some participants reported feeling less connected to counselors through remote communication. Though not mentioned by participants in this study, other studies on this topic describe unique challenges (such as a lack of technological savviness) that posed significant barriers to telebehavioral health satisfaction (
      • Hser Y.-I.
      • Ober A.J.
      • Dopp A.R.
      • Lin C.
      • Osterhage K.P.
      • Clingan S.E.
      • Mooney L.J.
      • Curtis M.E.
      • Marsch L.A.
      • McLeman B.
      • Hichborn E.
      • Lester L.S.
      • Baldwin L.-M.
      • Liu Y.
      • Jacobs P.
      • Saxon A.J.
      Is telemedicine the answer to rural expansion of medication treatment for opioid use disorder? Early experiences in the feasibility study phase of a National Drug Abuse Treatment Clinical Trials Network Trial.
      ;
      • Kang A.W.
      • DeBritz A.A.
      • Hoadley A.
      • DelaCuesta C.
      • Walton M.
      • Hurley L.
      • Martin R.
      Barriers and poor telephone counseling experiences among patients receiving medication for opioid use disorders.
      ;
      • Russell C.
      • Ali F.
      • Nafeh F.
      • Rehm J.
      • LeBlanc S.
      • Elton-Marshall T.
      Identifying the impacts of the COVID-19 pandemic on service access for people who use drugs (PWUD): A national qualitative study.
      ). Research suggests that dissatisfaction with telehealth may be more prevalent among patients receiving MT than those on other MOUDs (
      • Hunter S.B.
      • Dopp A.R.
      • Ober A.J.
      • Uscher-Pines L.
      Clinician perspectives on methadone service delivery and the use of telemedicine during the COVID-19 pandemic: A qualitative study.
      ). While this finding may be relevant to the sample in this current study, it is worthwhile to note that the participants who endorsed positive views regarding telehealth were those who experienced MT adherence challenges. Therefore, research should seek to understand the unique patient characteristics that predict satisfaction with telebehavioral health (
      • Cole T.O.
      • Robinson D.
      • Kelley-Freeman A.
      • Gandhi D.
      • Greenblatt A.D.
      • Weintraub E.
      • Belcher A.M.
      Patient satisfaction with medications for opioid use disorder treatment via telemedicine: brief literature review and development of a new assessment.
      ).
      As in-person operations at OTPs continue, a need still exists to examine the factors that impact telehealth satisfaction among patients receiving MOUD at OTPs, especially among those who may or may not experience MT adherence challenges, in preparation for future emergencies. The findings of this study mirror those reported by providers (
      • Uscher-Pines L.
      • Sousa J.
      • Raja P.
      • Mehrotra A.
      • Barnett M.
      • Huskamp H.A.
      Treatment of opioid use disorder during COVID-19: Experiences of clinicians transitioning to telemedicine.
      ), suggesting that both providers and patients perceived the benefits and costs of transitioning to more THM and tele-based care in OTP settings. These mixed perceptions suggest the need for more tailored care in these settings. OTPs are (by design) very regimented and do not allow for the tailoring of care that might better fit the needs of patients. This missing component of a patient-centered approach would potentially result in better outcomes.

      4.1 Limitations

      Results should be considered in the context of methodological limitations, including generalizability. This study recruited patients from a treatment program in an urban setting within which they were receiving care for their OUD. Although the researchers do not treat or make any treatment-related decisions, some participants may have felt uncomfortable sharing their thoughts regarding clinic operations. All participants in this study had been on MT for at least a year, and would not represent the experience of patients newly initiating MT. The study also has a risk of recall bias considering the length of time between the March 2020 changes and study interviews, which the team completed approximately one year after the OTP's changes went into effect. Despite these limitations, this study adds an important perspective to the literature as the first to utilize a targeted sampling approach (did not experience challenges vs. experienced challenges in treatment) to explore patients' perspectives regarding the COVID-19-induced OTP changes.

      5. Conclusion

      As COVID-19-responsive federal recommendations regarding THM are rolled back, policymakers should consider patients' perspectives to foster a more patient-centered approach to methadone dosing that is safe, flexible, and accommodates varied patients' needs. This study found a bifurcation in patients' experiences of the COVID-19-related changes to MT and telehealth visits with counselors that is important to consider when implementing a patient-centered system. A one-size-fits-all approach may obviate patient-centeredness and inadvertently impact patients' outcomes. Further research should quantitatively explore the impact of regulation changes on the treatment outcomes (e.g., treatment adherence and retention) of stable and less stable patients and factors that differentiate those who do well with extended THM. Additionally, technical support should be provided to OTPs beyond the pandemic to ensure an interpersonal connection is maintained in the patient-provider relationship in case of future emergencies.

      Funding source declaration

      This research was funded by the NIH HEAL Initiative (R61AT010799; PI: Magidson) and a COVID-19 supplement from NIH (R61AT010799-01S1; PIs: Belcher, Magidson). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

      Declaration of competing interest

      The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

      Acknowledgments

      The authors gratefully acknowledge the counseling staff of the University of Maryland Addiction Treatment Center for help with participant recruitment, patient participants for their time and thoughtful contributions, and colleagues, Morgan Anvari and Valerie Bradley for their assistance in drafting this manuscript. Finally, the authors acknowledge the feedback provided by the anonymous reviewers, whose careful and substantial review yielded a significantly improved manuscript.

      Appendix A. Supplementary Material

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