Enhancing Recovery Capital Amid Opioid Use Disorder Pharmacotherapy: A Pilot Randomized Trial

Official title

Developing and Testing an Intervention to Enhance Recovery Capital Amid Opioid Use Disorder Pharmacotherapy: A Pilot Randomized Trial of Linkage to Recovery Support Services

Overview

The aims of the current study are to: Aim 1. Develop and refine a novel intervention protocol for individuals receiving medication treatment for opioid use disorder that assertively links them to recovery community centers; Aim 2. Determine the feasibility, acceptability, and preliminary efficacy of assertive linkage to recovery community centers relative to a matched control condition, via a pilot randomized controlled trial; Aim 3. Explain quantitative findings by gaining an in-depth understanding of the intervention's feasibility, acceptability, and preliminary efficacy via qualitative interviews.

Detailed description

This 5-year project seek to advance our understanding of the clinical and public health utility of recovery community centers and help bridge the gap between clinical treatment and community-based recovery support services. As a first step in this work, the investigators will develop and test a new intervention for peer-facilitated assertive linkage of patients receiving opioid use disorder pharmacotherapy to recovery community centers (RCCL), relative to a matched control condition (CC). This study aims to: Aim 1. Develop, manualize, and refine RCCL and CC protocols via stakeholder feedback. RCCL and CC protocols will be developed and manualized by adapting published community-based mutual-help linkage protocols. Upon preliminary manual development, feedback cycles will be conducted with relevant stakeholders (recovery coaches, recovery community center members, pharmacotherapy prescribers) to inform protocol revision, and promote its feasibility, acceptability, and adoptability. Aim 2. Determine the feasibility, acceptability, and preliminary efficacy of RCCL versus CC, via a pilot randomized controlled trial. More specifically, the feasibility of study procedures and RCCL/CC interventions, acceptability of interventions, and preliminary efficacy of RCCL relative to CC will be assessed. Aim 3. Explain quantitative findings by gaining an in-depth understanding of RCCL feasibility, acceptability, and efficacy via qualitative interviews in a subset of RCCL participants, peer facilitators, and linkage managers.

Interventions

• Behavioral Recovery Community Center Linkage (RCCL)
  A certified recovery coach will meet with participants to educate them on recovery support services, including recovery community centers, and link them to a recovery community center, with the aid of a facilitated connection to a volunteer recovery community center member (e.g., calling a standby peer, scheduling a meet-up at the center). The coach will also provide the participant with a brochure of recovery support resources.
• Behavioral Control Condition (CC)
  A certified recovery coach will meet with participants to educate them on recovery support services more broadly, including recovery community centers, and will provide them with a brochure of recovery support resources.

Primary outcome measures

• Overall recruitment feasibility [Time frame: Through study completion, ~3 years from recruitment initiation]
• Overall intervention feasibility [Time frame: From the date of intervention manual finalization until the date of study completion, assessed up to 48 months]
• Fidelity: Linkage manager adherence [Time frame: From date of first linkage manager meeting until the date of last linkage manager meeting, assessed up to 36 months]
• Overall intervention acceptability [Time frame: Month 1]
• Overall intervention satisfaction [Time frame: Month 1]
• Recovery community center attendance [Time frame: From the date of linkage manager meeting until the date of month-3 follow up, assessed up to 3 months]
• Use of recovery support services [Time frame: From the date of linkage manager meeting until the date of month-3 follow up, assessed up to 3 months]

Secondary outcome measures (5)

• Participant retention [Time frame: From the date of first participant enrollment in the trial to the date of study completion, up to 42 months]
• Feasibility of peer facilitator meet-ups [Time frame: Month 1; Month 3]
• Intervention appropriateness [Time frame: Month 1]
• Intervention helpfulness [Time frame: Month 1; Month 3]
• Change in recovery capital from baseline to Month 3 [Time frame: Baseline; Month 1; Month 3]

Eligibility criteria

Inclusion criteria

• age ≥ 18 years
• past-year opioid use disorder diagnosis per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
• currently undergoing outpatient buprenorphine treatment through a provider or program at Massachusetts General Hospital
• current residence in Massachusetts

Exclusion criteria

• non-English fluency
• active suicidality
• neurodevelopmental disorders or neural trauma preventing informed consent
• active psychosis
• past-year attendance at a recovery community center or recovery support center

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

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Massachusetts General Hospital — Boston

Identifiers

NCT: NCT05245513 · 2021P003720

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗