Peer Recovery to Improve Polysubstance Use and Mobile Telemedicine Retention

Study Overview
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Brief Summary
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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 an underserved, rural area. 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
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There is a significant burden of opioid and polysubstance use, disproportionately affecting underserved, rural areas of the US. Yet many rural 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 aboard a mobile treatment unit (TM-MTU), led by University of Maryland Baltimore in partnership with Maryland Department of Health, has helped fill the void of rural practitioners by providing buprenorphine for OUD treatment in rural 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 via the TM-MTU 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 rural 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. The investigators propose a randomized Type 1 hybrid effectiveness-implementation trial (n=180) to evaluate Peer Activate-MTU compared to ETAU. Specific aims are to evaluate the effectiveness of Peer Activate-MTU over 12-months on polysubstance use, as well as OUD treatment retention and buprenorphine adherence. The investigators will also evaluate the implementation of Peer-Active-MTU, including feasibility, acceptability, fidelity, and adoption guided by RE-AIM.

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

Conditions
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Polysubstance Addiction, Opioid Medication Assisted Treatment, Treatment Adherence, Retention in Care, Substance-Related Disorders

Intervention / Treatment
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* Behavioral: Peer-Delivered Behavioral Activation (Peer Activate)


Participation Criteria
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Eligibility Criteria
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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 Positive pregnancy status at enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized in parallel to receive either the Peer Activate intervention on the MTU or enhanced treatment as usual (TAU: treatment as usual services on the MTU in addition to referral to other available services in the community through study contact). Assessments will take place for both groups at baseline, at a midpoint (1-month), and follow ups at 3-month, 6-month and 12-months following the baseline assessment. Follow up assessments will be conducted by a blinded assessor.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peer-Delivered Behavioral Activation (Peer Activate)<br>Participants in the Peer Activate intervention will receive a PRS-delivered behavioral activation intervention to address barriers to retention in methadone treatment and increase substance-free, positive reinforcement to support retention and reduce polysubstance use. | Behavioral: Peer-Delivered Behavioral Activation (Peer Activate)<br>* 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.<br>|
| No Intervention: Treatment As Usual<br>Participants in the TAU group will receive enhanced treatment as usual, defined as MTU services as usual enhanced with additional community referrals and follow-ups on those referrals, in addition to regular meetings with an addiction medicine physician and PRS on the MTU. Standard PRS contact typically includes connection to local resources and general peer support as needed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-Month Polysubstance Use Urinalysis | Polysubstance use will be assessed using urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine. | Measured from baseline to 6-month follow-up | 
| Six-Month Polysubstance Use Self Report | The New York University (NYU) polysubstance use measurement tool will be utilized to assess polysubstance frequency. | Assessed between the baseline assessment 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-month OUD Treatment Retention | Retention is measured using chart review of clinic records of appointment attendance. Retention will be assessed measured as dichotomous retention (yes/no) at six months post MOUD initiation. | Measured from intake through 6-month follow up | 
| Six-month Buprenorphine Adherence | Buprenorphine adherence will be assessed through urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine. Continuity of pharmacy for MOUD through 6 months will be assessed and calculated via the percent retained on MT for at least 6 months, defined as having one or more additional MOUD-related visits for each 30-day period up to 6 months. | Measured from intake to six-month follow-up | 
| Six-month Self-Report Buprenorphine Adherence | The IRA Wilson will be utilized to assess self-report buprenorphine adherence | Assessed between the baseline assessment and 6-month follow-up | 
| Six-Month Problems Associated with Substance Use | Problems associated with use will be assessed using the Short Inventory of Problems (SIP), a 15-item measure that will be used to assess five domains of impairment related to polysubstance use. | Assessed between the baseline assessment and 6-month follow-up | 
| Intervention Uptake | Feasibility, defined as the suitability and practicability of the approach, will be measured quantitatively as the % of patients who agree to participate in the intervention. | Assessed between the baseline assessment and 6-month follow-up | 
| Intervention Session Attendance | Acceptability, defined as satisfaction with or tolerability of the proposed approach, will be measured quantitatively by session attendance. Specifically, % of patients enrolled who attend ≥75% sessions will be measured. | Assessed between the baseline assessment 6-month follow-up | 
| Intervention Fidelity | Fidelity, defined as the delivery of the intervention as intended, will be measured based on PRS adherence to the intervention delivery. A random selection of 20% of sessions will be rated for fidelity by an independent rater, and % of intervention components delivered as intended will be measured. | Assessed at the acute post-treatment follow-up (approximately 3-months post-baseline assessment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Substance-Related Disorders, Opioid-Related Disorders, Polysubstance Use, Mental disorders