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

Mass General Brigham

Status: Not yet enrolling

Conditions: Opioid Use Disorder

Treatments: Behavioral: Control Condition (CC); Behavioral: Recovery Community Center Linkage (RCCL)

Study type: Interventional

Funder types: Other

Identifiers

NCT05245513

2021P003720

Details and patient eligibility

About

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.

Full 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.

Enrollment: 145 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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145 participants in 2 patient groups

Recovery Community Center Linkage (RCCL)

Experimental group

Description:

The RCCL arm will involve a brief (\~20 minutes) meeting with a recovery coach (i.e. linkage manager), in which the recovery coach will inform the participant of 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 (i.e. peer facilitator). The linkage manager will also provide the participant with a list of recovery support service resources.

Treatment:

Behavioral: Recovery Community Center Linkage (RCCL)

Control Condition (CC)

Active Comparator group

Description:

The CC arm will involve a time-matched meeting with a recovery coach (i.e. linkage manager), in which the recovery coach will broadly inform the participant of recovery support services, including recovery community centers, and provide them with a list of recovery support service resources.

Treatment:

Behavioral: Control Condition (CC)