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Recruiting NCT05973838

Peer Recovery to Improve Polysubstance Use and Mobile Telemedicine Retention

No phase Interventional Polysubstance Addiction Opioid Medication Assisted Treatment Treatment Adherence Retention in Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Peer-Delivered Behavioral Activation ("Peer Activate").
Who it may be relevant to
Registry conditions: Polysubstance Addiction, Opioid Medication Assisted Treatment, Treatment Adherence, Retention in Care. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Peer-Delivered, Behavioral Activation Intervention to Improve Polysubstance Use and Retention in Mobile Telemedicine OUD Treatment in an Underserved, Rural Area

Overview

The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led, brief, behavioral intervention to improve adherence to medication for opioid use disorder (MOUD) and reduce polysubstance use among patients with OUD and polysubstance use in underserved areas. The intervention is based on behavioral activation (BA) and is specifically designed to be implemented by a trained peer recovery specialist. In this hybrid, Type-1 effectiveness-implementation randomized controlled trial (RCT), the investigators will evaluate the effectiveness and implementation of Peer Activate vs. treatment as usual (TAU) over twelve months.

Detailed description

There is a significant burden of opioid and polysubstance use within the US. Yet many communities are poorly equipped to meet the pressing need for addiction treatment, including medications for OUD (MOUD) and evidence-based interventions (EBIs) to address the rise in opioid use disorder (OUD) and co-occurring stimulant use. The availability of telemedicine has helped fill the void of practitioners by providing buprenorphine for OUD treatment in underserved areas, however, OUD treatment retention remains an ongoing challenge, with polysubstance use and stimulant use exacerbating this. Peer recovery specialists (PRSs), trained individuals with their own lived experience with substance use disorder (SUD) and recovery, are a promising strategy to improve OUD treatment retention and polysubstance use at these sites using a reinforcement-based approach.

Behavioral activation (BA) may be a feasible, scalable, reinforcement-based approach for improving OUD treatment retention and reducing polysubstance use in underserved areas. By targeting increases in positive reinforcement, BA has been found to be effective for improving SUD treatment retention, preventing future relapse, including for stimulant use specifically, and improving medication adherence (i.e., for HIV) among low-income, minority populations with SUD as well as depression, which is a barrier to MOUD retention. BA has been shown to be feasibly delivered by peers and community health workers.

This study proposes to evaluate the effectiveness, implementation, and cost-effectiveness of an adapted PRS-delivered BA approach on the TM-MTU ("Peer Activate-MTU") compared to enhanced treatment as usual (ETAU; facilitated referrals and general PRS support) for patients with OUD and other polysubstance use receiving telemedicine buprenorphine. The investigators propose a randomized Type 1 hybrid effectiveness-implementation trial (n=160) to evaluate Peer Activate-MTU compared to ETAU. Specific aims are to evaluate the effectiveness of Peer Activate-MTU over 12-months on OUD treatment retention and polysubstance use. The investigators will also evaluate the implementation of Peer-Active-MTU, including feasibility, acceptability, fidelity, and adoption guided by RE-AIM.

Interventions

  • Behavioral Peer-Delivered Behavioral Activation ("Peer Activate")
    The PRS-delivered Peer Activate intervention will consist of approximately six weekly "core" sessions (approximately 30 minutes-1 hour), and then 6 optional "booster" sessions to reinforce skill practice. In Peer Activate sessions, participants will learn behavioral activation and problem-solving skills to reduce barriers to medication nonadherence and incorporate value-driven, substance-free, rewarding activities into their daily life to reduce polysubstance use and improve retention.

Primary outcome measures

  • Six-Month Polysubstance Use Urinalysis [Time frame: Measured from baseline to 6-month follow-up]
  • Six-Month Polysubstance Use Self Report [Time frame: Assessed between the baseline assessment 6-month follow-up]
Secondary outcome measures (7)
  • Six-month OUD Treatment Retention [Time frame: Measured from intake through 6-month follow up]
  • Six-month Buprenorphine Adherence [Time frame: Measured from intake to six-month follow-up]
  • Six-month Self-Report Buprenorphine Adherence [Time frame: Assessed between the baseline assessment and 6-month follow-up]
  • Six-Month Problems Associated with Substance Use [Time frame: Assessed between the baseline assessment and 6-month follow-up]
  • Intervention Uptake [Time frame: Assessed between the baseline assessment and 6-month follow-up]
  • Intervention Session Attendance [Time frame: Assessed between the baseline assessment 6-month follow-up]
  • Intervention Fidelity [Time frame: Assessed at the acute post-treatment follow-up (approximately 3-months post-baseline assessment)]

Eligibility criteria

Inclusion criteria

Patient participants in the RCT must be 18 or older; receive OUD treatment as part of the telemedicine program; and exhibit polysubstance use within the past three-months (i.e., use of one or more non-prescribed substances (excluding opioids and/or tobacco) by urine toxicology or self-report.

Exclusion criteria

  • Demonstrating active, unstable or untreated psychiatric symptoms, including mania and/or psychosis that would interfere with study participation
  • Inability to understand the study and provide informed consent in English

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 4 centers
  • HIPS Clinic — Washington D.C.
  • University of Maryland Baltimore (UMD Drug Treatment Center) — Baltimore
  • University of Maryland, College Park — College Park
  • Caroline County Behavioral Health — Denton

Publications

  • Ghertner R. U.S. trends in the supply of providers with a waiver to prescribe buprenorphine for opioid use disorder in 2016 and 2018. Drug Alcohol Depend. 2019 Nov 1;204:107527. doi: 10.1016/j.drugalcdep.2019.06.029. Epub 2019 Aug 30. PMID 31525570
  • Magidson JF, Gorka SM, MacPherson L, Hopko DR, Blanco C, Lejuez CW, Daughters SB. Examining the effect of the Life Enhancement Treatment for Substance Use (LETS ACT) on residential substance abuse treatment retention. Addict Behav. 2011 Jun;36(6):615-623. doi: 10.1016/j.addbeh.2011.01.016. Epub 2011 Jan 21. PMID 21310539
  • Mimiaga MJ, Reisner SL, Pantalone DW, O'Cleirigh C, Mayer KH, Safren SA. A pilot trial of integrated behavioral activation and sexual risk reduction counseling for HIV-uninfected men who have sex with men abusing crystal methamphetamine. AIDS Patient Care STDS. 2012 Nov;26(11):681-93. doi: 10.1089/apc.2012.0216. Epub 2012 Oct 3. PMID 23030605
  • Mimiaga MJ, Pantalone DW, Biello KB, Hughto JMW, Frank J, O'Cleirigh C, Reisner SL, Restar A, Mayer KH, Safren SA. An initial randomized controlled trial of behavioral activation for treatment of concurrent crystal methamphetamine dependence and sexual risk for HIV acquisition among men who have sex with men. AIDS Care. 2019 Sep;31(9):1083-1095. doi: 10.1080/09540121.2019.1595518. Epub 2019 Mar 19 PMID 30887824
  • Daughters SB, Magidson JF, Anand D, Seitz-Brown CJ, Chen Y, Baker S. The effect of a behavioral activation treatment for substance use on post-treatment abstinence: a randomized controlled trial. Addiction. 2018 Mar;113(3):535-544. doi: 10.1111/add.14049. Epub 2017 Nov 19. PMID 28963853
  • Magidson JF, Seitz-Brown CJ, Safren SA, Daughters SB. Implementing Behavioral Activation and Life-Steps for Depression and HIV Medication Adherence in a Community Health Center. Cogn Behav Pract. 2014 Nov 1;21(4):386-403. doi: 10.1016/j.cbpra.2013.10.002. PMID 25419102
  • Magidson JF, Joska JA, Regenauer KS, Satinsky E, Andersen LS, Seitz-Brown CJ, Borba CPC, Safren SA, Myers B. "Someone who is in this thing that I am suffering from": The role of peers and other facilitators for task sharing substance use treatment in South African HIV care. Int J Drug Policy. 2019 Aug;70:61-69. doi: 10.1016/j.drugpo.2018.11.004. Epub 2019 May 10. PMID 31082664
  • Daughters SB, Magidson JF, Schuster RM, Safren SA. ACT HEALTHY: A Combined Cognitive-Behavioral Depression and Medication Adherence Treatment for HIV-Infected Substance Users. Cogn Behav Pract. 2010 Aug 1;17(3):309-321. doi: 10.1016/j.cbpra.2009.12.003. PMID 21709737

Identifiers

NCT: NCT05973838 · 1953327 · R01DA057443

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗