Clinical trial NCT05245513: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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

Primary outcomes:
measure: Overall recruitment feasibility
timeFrame: Through study completion, ~3 years from recruitment initiation
measure: Overall intervention feasibility
timeFrame: From the date of intervention manual finalization until the date of study completion, assessed up to 48 months
measure: Fidelity: Linkage manager adherence
timeFrame: From date of first linkage manager meeting until the date of last linkage manager meeting, assessed up to 36 months
measure: Overall intervention acceptability
timeFrame: Month 1
measure: Overall intervention satisfaction
timeFrame: Month 1
measure: Recovery community center attendance
timeFrame: From the date of linkage manager meeting until the date of month-3 follow up, assessed up to 3 months
measure: Use of recovery support services
timeFrame: From the date of linkage manager meeting until the date of month-3 follow up, assessed up to 3 months
Secondary outcomes:
measure: Participant retention
timeFrame: From the date of first participant enrollment in the trial to the date of study completion, up to 42 months
measure: Feasibility of peer facilitator meet-ups
timeFrame: Month 1; Month 3
measure: Intervention appropriateness
timeFrame: Month 1
measure: Intervention helpfulness
timeFrame: Month 1; Month 3
measure: Change in recovery capital from baseline to Month 3
timeFrame: Baseline; Month 1; Month 3
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: