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

NCT05245513 | Not Yet Recruiting

• 1 other identifier: 2021P003720
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (7)

• Overall recruitment feasibility

  Number of participants successfully recruited within allotted recruitment time frame (\~3 years)

  Through study completion, ~3 years from recruitment initiation

• Overall intervention feasibility

  Assessed via the Feasibility: Intervention Implementation \& Training scale average total score. This is a 2-item instrument to assess perceived intervention feasibility. Items are measured on a 6-point Likert scale (Strongly Disagree-Strongly Agree). Score is the calculated mean. Higher scores indicate greater feasibility.

  From the date of intervention manual finalization until the date of study completion, assessed up to 48 months

• Fidelity: Linkage manager adherence

  Percent adherence of linkage managers to intervention protocols, as evaluated by the percentage of sessions that are scored with adequate adherence and assessed by recordings of intervention delivery and adherence evaluation materials developed as part of Aim 1 (e.g., adherence rating scales of critical topics). This is a 14-item instrument evaluating the extensiveness of linkage managers' delivery of critical intervention topics. Items are measured on a 5-point Likert scale (Not at all - Extensively). Score is the calculated mean. Total scores range from 1 to 5, with scores \> 3 indicating adequate adherence.

  From date of first linkage manager meeting until the date of last linkage manager meeting, assessed up to 36 months

• Overall intervention acceptability

  Assessed via 1 single-item statement addressing the the acceptability of the intervention. The item is measured on a 6-point Likert scale (Strongly Disagree - Strongly Agree). Higher scores indicate greater acceptability.

  Month 1

• Overall intervention satisfaction

  Assessed via the Client Satisfaction Questionnaire-8 (CSQ8) total score. This is an 8 item measure of client satisfaction with services. Total scores range from 8 to 32, with higher scores indicating greater satisfaction.

  Month 1

• Recovery community center attendance

  Percent of participants who attended a recovery community center 1+ time post linkage manager meeting, as assessed via the Timeline Follow Back

  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

  Percent days use of any recovery support services post linkage manager meeting, as assessed via the Timeline Follow Back

  From the date of linkage manager meeting until the date of month-3 follow up, assessed up to 3 months

Secondary Outcomes (5)

• Participant retention

  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

  Month 1; Month 3

• Intervention appropriateness

  Month 1

• Intervention helpfulness

  Month 1; Month 3

• Change in recovery capital from baseline to Month 3

  Baseline; Month 1; Month 3

Study Arms (2)

Recovery Community Center Linkage (RCCL)

EXPERIMENTAL

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.

Behavioral: Recovery Community Center Linkage (RCCL)

Control Condition (CC)

ACTIVE COMPARATOR

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.

Behavioral: Control Condition (CC)

Interventions

Recovery Community Center Linkage (RCCL) BEHAVIORAL

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.

Recovery Community Center Linkage (RCCL)

Control Condition (CC) BEHAVIORAL

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.

Control Condition (CC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Lauren A Hoffman, PhD

CONTACT

(617) 643-4690; lhoffman1@mgh.harvard.edu

John F Kelly, PhD

CONTACT

(617) 643-1980; jkelly11@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 18, 2022
• Study Start: December 1, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)