Advertisement
Discussion| Volume 120, 108149, January 2021

Mobile van delivery of extended-release buprenorphine and extended-release naltrexone for youth with OUD: An adaptation to the COVID-19 emergency

  • Kevin Wenzel
    Correspondence
    Corresponding author.
    Affiliations
    Mountain Manor Treatment Center/Maryland Treatment Centers, 3800 Frederick Ave, Baltimore, MD 21229, USA
    Search for articles by this author
  • Marc Fishman
    Affiliations
    Mountain Manor Treatment Center/Maryland Treatment Centers, 3800 Frederick Ave, Baltimore, MD 21229, USA

    Johns Hopkins University School of Medicine, Department of Psychiatry and Behavioral Sciences, 600 N Wolfe St, Baltimore, MD 21205, USA
    Search for articles by this author
Published:September 24, 2020DOI:https://doi.org/10.1016/j.jsat.2020.108149

      Abstract

      The Youth Opioid Recovery Support (YORS) intervention is a novel treatment for young adults with opioid use disorder (OUD) that uses developmentally informed strategies to reduce barriers to treatment engagement. YORS strategies, such as home delivery of extended-release buprenorphine and extended-release naltrexone for OUD, are designed to increase engagement in treatment, but with the COVID-19 pandemic these strategies increase risk of virus exposure and spread to patients and staff entering homes. We present mobile van service delivery as a potential solution to continuing to provide low-barrier care for young adults with OUD while reducing risk associated with COVID-19. Initial feedback from patients and staff is positive and lays the groundwork to test feasibility and acceptability of this intervention rigorously in future work. Mobile van delivery of extended-release medications for OUD may be a promising treatment modification for mitigating risk of COVID-19, as well as a useful option for ongoing enhancement of care.

      1. Background

      Young adults are disproportionately vulnerable to the current opioid crisis with well-known and devastating consequences (
      • Substance Abuse and Mental Health Services Administration
      Key substance use and mental health indicators in the United States: Results from the 2016 National Survey on Drug Use and Health.
      ). They have low rates of pharmacotherapy initiation (
      • Hadland S.E.
      • Bagley S.M.
      • Rodean J.
      • Silverstein M.
      • Levy S.
      • Larochelle M.
      • Zima B.T.
      Receipt of timely addiction treatment and association of early medication treatment with retention in care among youths with opioid use disorder.
      ), substantial difficulties with retention in treatment (
      • Matson S.C.
      • Hobson G.
      • Abdel-Rasoul M.
      • Bonny A.E.
      A retrospective study of retention of opioid-dependent adolescents and young adults in an outpatient buprenorphine/naloxone clinic.
      ;
      • Mutlu C.
      • Demirci A.C.
      • Yalcin O.
      • Kilicoglu A.G.
      • Topal M.
      • Karacetin G.
      One-year follow up of heroin-dependent adolescents treated with buprenorphine/naloxone for the first time in a substance treatment unit.
      ;
      • Woody G.E.
      • Poole S.A.
      • Subramaniam G.
      • Dugosh K.
      • Bogenschutz M.
      • Abbott P.
      • Fudala P.
      Extended vs. short-term buprenorphine-naloxone for treatment of opioid addicted youth: A randomized trial.
      ), and have poorer treatment outcomes compared to older adults (
      • Fishman M.
      • Wenzel K.
      • Scodes J.
      • Pavlicova M.
      • Lee J.D.
      • Rotrosen J.
      • Nunes E.
      Young adults have worse outcomes than older adults: Secondary analysis of a medication trial for opioid use disorder.
      ). Several strategies have promise for addressing these barriers. Extended-release medication formulations have the potential to help overcome adherence challenges that daily medications present, but even with this strategy there are adherence limitations among youth (
      • Mitchell S.
      • Schwartz R.
      • Fishman M.
      • Zarkin G.
      • Dunlap L.
      Extended-release naltrexone research with adolescents and young adults.
      ). Practitioners have used home delivery of medications and assertive outreach approaches for treatment of severe mental illness and other chronic health conditions, such as TB and HIV (
      • Jit M.
      • Stagg H.R.
      • Aldridge R.W.
      • White P.J.
      • Abubakar I.
      Dedicated outreach service for hard to reach patients with tuberculosis in London: Observational study and economic evaluation.
      ;
      • Needle R.H.
      • Burrows D.
      • Friedman S.R.
      • Dorabjee J.
      • Touze G.
      • Badrieva L.
      • Latkin C.
      Effectiveness of community-based outreach in preventing HIV/AIDS among injecting drug users.
      ;
      • Rosenheck R.
      • Dennis D.
      Time-limited assertive community treatment for homeless persons with severe mental illness.
      ), for which medication adherence is vital to treatment success. Researchers have used and studied mobile delivery (e.g., using a van) for sublingual buprenorphine (
      • Krawczyk N.
      • Buresh M.
      • Gordon M.S.
      • Blue T.R.
      • Fingerhood M.I.
      • Agus D.
      Expanding low-threshold buprenorphine to justice-involved individuals through mobile treatment: Addressing a critical care gap.
      ;
      • Sullivan L.E.
      • Bruce R.D.
      • Haltiwanger D.
      • Lucas G.M.
      • Eldred L.
      • Finkelstein R.
      • Fiellin D.A.
      Initial strategies for integrating buprenorphine into HIV care settings in the United States.
      ) and methadone (
      • Greenfield L.
      • Brady J.V.
      • Besteman K.J.
      • De Smet A.
      Patient retention in mobile and fixed-site methadone maintenance treatment.
      ;
      • Hall G.
      • Neighbors C.J.
      • Iheoma J.
      • Dauber S.
      • Adams M.
      • Culleton R.
      • Morgenstern J.
      Mobile opioid agonist treatment and public funding expands treatment for disenfranchised opioid-dependent individual.
      ) in adults, but to our knowledge there is no research on such mobile delivery for youth. There is also evidence of other assertive strategies being used effectively in youth with SUD (
      • Godley S.H.
      • Garner B.R.
      • Passetti L.L.
      • Funk R.R.
      • Dennis M.L.
      • Godley M.D.
      Adolescent outpatient treatment and continuing care: Main findings from a randomized clinical trial.
      ).
      Our group has developed and tested the Youth Opioid Recovery Support (YORS) intervention, an assertive wrap-around approach designed to increase medication adherence and treatment engagement through nonlinear recovery trajectories (see
      • Fishman M.
      • Wenzel K.
      • Vo H.
      • Wildberger J.
      • Burgower R.
      A pilot randomized controlled trial of assertive treatment including family involvement and home delivery of medication for young adults with opioid use disorder.
      including a preliminary treatment manual as supplemental material;
      • Wenzel K.
      • Wildberger J.
      • Fishman M.
      • Selby V.
      • Lavorato L.
      • Thomas J.
      Expanding patient choice of medication in the Youth Opioid Recovery Support (YORS) intervention–Extended-release naltrexone or extended-release buprenorphine.
      ). We approached to enroll in the program young adults with OUD who select extended-release buprenorphine (XR-BUP) or extended-release naltrexone (XR-NTX) as their relapse prevention medication through standard care. YORS has four components: 1) Home delivery of patient's choice of extended-release medication for opioid use disorder (XR-MOUD), either: XR-NTX or XR-BUP for OUD; 2) engagement of families in collaborative treatment planning and monitoring focusing on medication adherence; 3) assertive outreach: actively tracking and communicating with youth and families by text and social media to promote engagement and adherence; and 4) contingency management: to provide incentives for medication adherence.
      The COVID-19 pandemic further exacerbates the barriers to engagement and adherence for this already difficult-to-engage population. For many, COVID-19 has created further ambivalence about recovery and anxiety about exposure risk. Moreover, the strategies in YORS designed to increase engagement, such as entering the homes of young adults to deliver XR-MOUD, may actually increase risk of virus exposure both to the members of the patient's household and to staff entering the household. Risk of exposure associated with home delivery is especially relevant for young adults with OUD, as many live in recovery housing with others in close proximity or in a multigenerational family home.
      We recently began a project funded through the NIH HEAL initiative (
      • National Institutes of Health
      Helping to end addiction long-term.
      ) to further refine and test the YORS intervention through iterative cycles of testing, participant feedback, and refinement, ultimately leading to a larger randomized controlled trial. We have focused our initial refinements on addressing risk reduction associated with COVID-19 while also reducing barriers to treatment for OUD.

      2. Current treatment services adaptation

      Mobile van delivery presents a potential solution to balancing COVID-19 risk reduction and overcoming barriers to medication adherence. Although we have tested the YORS intervention with positive results (
      • Fishman M.
      • Wenzel K.
      • Scodes J.
      • Pavlicova M.
      • Lee J.D.
      • Rotrosen J.
      • Nunes E.
      Young adults have worse outcomes than older adults: Secondary analysis of a medication trial for opioid use disorder.
      ;
      • Wenzel K.
      • Wildberger J.
      • Fishman M.
      • Selby V.
      • Lavorato L.
      • Thomas J.
      Expanding patient choice of medication in the Youth Opioid Recovery Support (YORS) intervention–Extended-release naltrexone or extended-release buprenorphine.
      ), we have not tested mobile van delivery as a component of YORS. To this end, our group has developed a protocol for mobile van delivery of XR-MOUD for OUD, and has pilot tested the procedure on about a dozen young adult patients (Fig. 1) .
      Fig. 1
      Fig. 1A photograph of mobile van delivery of extended-release buprenorphine.
      Prior to mobile delivery, the patient is contacted to inform them of the procedures, obtain consent, confirm their physical location, and screen for COVID-19 symptoms and risk of exposure. The mobile van delivery procedures are used only for patients who screen as low risk to exposure. Alternative strategies for patients deemed high risk may include waiting until risk shifts to low according to CDC guidelines, increased support through telehealth counseling, temporarily switching to daily formulations of naltrexone or buprenorphine, or additional family involvement and education.
      Patients receive van-delivered XR-MOUD via a passenger van with some seats removed to maximize space for comfort and mobility, but with a bench seat retained for delivering the injection. Polyurethane seats, steering wheel, and dash are easily sanitized before and after each visit with a disinfectant solution and washable cloth. Van windows are covered with rip paper to protect patient confidentiality, and air conditioning or windows are used to maximize airflow to decrease the likelihood of transmission.
      Our current staffing has included at least a 2-person team of a nurse for injection delivery and a therapist for case management and abbreviated psychotherapy sessions as feasible. The physician is available by telephone as needed. Staff contacts the patient when leaving the treatment facility and again upon arrival to the residence to ask them to come outside. Patients are greeted and provided with a disposable mask upon arrival if needed. After a brief orientation to the van and procedures, patients provide a urine sample in their residence and deliver it to staff back in the van for point-of-care testing. Therapists can hold brief counseling sessions with patients either inside the van or outside the van depending on ability to find a comfortable and confidential location.
      Initial, informal feedback from patients and staff is encouraging. One patient expressed, “It's better than not getting the shot!” Others have given feedback that they prefer it to standard home delivery due to concern for older relatives or embarrassment of clinical staff entering their home. One patient's feedback supported a 2-person delivery team because, “as a female, I would be uncomfortable with just one man in the van”. We have also tested a 1-person operation consisting of a nurse performing a medication management session without the therapist. Staff feedback has generally been very positive toward this procedure, in comparison to the alternative of entering someone's home.

      3. Conclusions and implications for the future

      In our limited pilot experience so far, mobile van delivery of XR-MOUD to young adults has been well received by both patients and staff. The controlled and disinfect-able dosing environment reduces COVID-19 exposure risk and seems to alleviate anxieties in comparison to previous in-home delivery procedures.
      In addition to its clear utility for infection control, the van-based procedure may have other advantages. Van delivery could address concerns that a minority of patients have expressed about lack of confidentiality or a subjective sense of intrusiveness with in-home delivery. Additionally, van delivery might help with the rare concerns raised by staff in the past regarding security in some households. We also plan to test the addition of telehealth services during the delivery. For example, a clinician could conduct a brief remote session via telehealth while the patient is in the van, using a laptop brought by the nurse, or the patient's mobile phone. This approach might offer the advantage of immediacy as well as a team approach to care delivery, and may increase engagement compared to telehealth appointments attempted at a later time.
      One potential limitation of van delivery is that the in-home setting has frequently led in the past to the easy availability of a family member (or other treatment significant other) who can add valuable in-the-moment persuasion or leverage for treatment adherence. This may be addressed by inviting the family member out to the van or to a discreet location outdoors, but we have not yet tested that approach. Much of the in-person family engagement component of YORS has been adapted to video-conferencing and assertive text messaging. Another potential limitation, although we have not seen this so far, is a hypothetical concern about any stigma or embarrassment with entering a van in public view, especially in crowded urban areas. In the future, we can easily envision a van-based team that could have the option and make an individualized decision about whether to administer a dose in the van or in the home.
      While our limited experience has been positive, these preliminary, anecdotal results need further confirmation. Further, the sustainability of the YORS intervention in general (whether using in-home or van-based dosing) under nonresearch real-world reimbursement conditions remains unknown; we are awaiting planned economic analysis to document the value proposition. Nevertheless, given what we know now, we are optimistic that mobile van delivery may present not only a prudent adaptation during the COVID-19 pandemic, but also a new tool to add to the therapeutic repertoire even beyond the current emergency. This new strategy could be flexibly applied as an enduring patient-centered component of the YORS intervention for the provision of care to young adults with high-severity OUD. Further, mobile van delivery of XR medications, as an assertive community strategy for increasing access and adherence to MOUD, might also have broader applicability, and may be worthy of testing in other hard-to-reach populations.

      Declaration of competing interest

      Dr Fishman has been a paid consultant for Alkermes, which makes extended-release naltrexone, one of the medications given in this intervention.
      Part of the procedures described in this manuscript were supported by a research grant from the University of Maryland Center for Addiction Research Education and Service and the National Center for Complementary & Integrative Health (1R61AT01614-01).

      References

        • Fishman M.
        • Wenzel K.
        • Scodes J.
        • Pavlicova M.
        • Lee J.D.
        • Rotrosen J.
        • Nunes E.
        Young adults have worse outcomes than older adults: Secondary analysis of a medication trial for opioid use disorder.
        Journal of Adolescent Health. 2020; https://doi.org/10.1016/j.jadohealth.2020.07.038
        • Fishman M.
        • Wenzel K.
        • Vo H.
        • Wildberger J.
        • Burgower R.
        A pilot randomized controlled trial of assertive treatment including family involvement and home delivery of medication for young adults with opioid use disorder.
        Addiction. 2020; https://doi.org/10.1111/add.15181
        • Godley S.H.
        • Garner B.R.
        • Passetti L.L.
        • Funk R.R.
        • Dennis M.L.
        • Godley M.D.
        Adolescent outpatient treatment and continuing care: Main findings from a randomized clinical trial.
        Drug and Alcohol Dependence. 2010; 110: 44-54https://doi.org/10.1016/j.drugalcdep.2010.02.003
        • Greenfield L.
        • Brady J.V.
        • Besteman K.J.
        • De Smet A.
        Patient retention in mobile and fixed-site methadone maintenance treatment.
        Drug and Alcohol Dependence. 1996; 42: 125-131https://doi.org/10.1016/0376-8716(96)01273-2
        • Hadland S.E.
        • Bagley S.M.
        • Rodean J.
        • Silverstein M.
        • Levy S.
        • Larochelle M.
        • Zima B.T.
        Receipt of timely addiction treatment and association of early medication treatment with retention in care among youths with opioid use disorder.
        Journal of the American Medical Association Pediatrics. 2018; 172: 1029-1037
        • Hall G.
        • Neighbors C.J.
        • Iheoma J.
        • Dauber S.
        • Adams M.
        • Culleton R.
        • Morgenstern J.
        Mobile opioid agonist treatment and public funding expands treatment for disenfranchised opioid-dependent individual.
        Journal of Substance Abuse Treatment. 2014; 46: 511-515https://doi.org/10.1016/j.jsat.2013.11.002
        • Jit M.
        • Stagg H.R.
        • Aldridge R.W.
        • White P.J.
        • Abubakar I.
        Dedicated outreach service for hard to reach patients with tuberculosis in London: Observational study and economic evaluation.
        British Medical Journal. 2011; 343: 1-11https://doi.org/10.1136/bmj.d5376
        • Krawczyk N.
        • Buresh M.
        • Gordon M.S.
        • Blue T.R.
        • Fingerhood M.I.
        • Agus D.
        Expanding low-threshold buprenorphine to justice-involved individuals through mobile treatment: Addressing a critical care gap.
        Journal of Substance Abuse Treatment. 2019; 103: 1-8https://doi.org/10.1016/j.jsat.2019.05.002
        • Matson S.C.
        • Hobson G.
        • Abdel-Rasoul M.
        • Bonny A.E.
        A retrospective study of retention of opioid-dependent adolescents and young adults in an outpatient buprenorphine/naloxone clinic.
        Journal of Addiction Medicine. 2014; 8: 176-182
        • Mitchell S.
        • Schwartz R.
        • Fishman M.
        • Zarkin G.
        • Dunlap L.
        Extended-release naltrexone research with adolescents and young adults.
        NIDA/SAMHSA Panel, Rockville, MD2018
        • Mutlu C.
        • Demirci A.C.
        • Yalcin O.
        • Kilicoglu A.G.
        • Topal M.
        • Karacetin G.
        One-year follow up of heroin-dependent adolescents treated with buprenorphine/naloxone for the first time in a substance treatment unit.
        Journal of Substance Abuse Treatment. 2016; 67: 1-8
        • National Institutes of Health
        Helping to end addiction long-term.
        (Retrieved from)
        • Needle R.H.
        • Burrows D.
        • Friedman S.R.
        • Dorabjee J.
        • Touze G.
        • Badrieva L.
        • Latkin C.
        Effectiveness of community-based outreach in preventing HIV/AIDS among injecting drug users.
        International Journal of Drug Policy. 2005; 16: 45-57https://doi.org/10.1016/j.drugpo.2005.02.009
        • Rosenheck R.
        • Dennis D.
        Time-limited assertive community treatment for homeless persons with severe mental illness.
        Archives of General Psychiatry. 2001; 58: 1073-1080https://doi.org/10.1001/archpsyc.58.11.1073
        • Substance Abuse and Mental Health Services Administration
        Key substance use and mental health indicators in the United States: Results from the 2016 National Survey on Drug Use and Health.
        (Retrieved from)
        • Sullivan L.E.
        • Bruce R.D.
        • Haltiwanger D.
        • Lucas G.M.
        • Eldred L.
        • Finkelstein R.
        • Fiellin D.A.
        Initial strategies for integrating buprenorphine into HIV care settings in the United States.
        Clinical Infectious Diseases. 2006; 43: 191-196https://doi.org/10.1086/508183
        • Wenzel K.
        • Wildberger J.
        • Fishman M.
        • Selby V.
        • Lavorato L.
        • Thomas J.
        Expanding patient choice of medication in the Youth Opioid Recovery Support (YORS) intervention–Extended-release naltrexone or extended-release buprenorphine.
        2020, October (Anticipated poster presentation at the annual conference for the Association for Medical Education and Research in Substance Abuse)
        • Woody G.E.
        • Poole S.A.
        • Subramaniam G.
        • Dugosh K.
        • Bogenschutz M.
        • Abbott P.
        • Fudala P.
        Extended vs. short-term buprenorphine-naloxone for treatment of opioid addicted youth: A randomized trial.
        Journal of the American Medical Association. 2008; 300: 2003-2011