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

Opioid Use Disorder Clinical 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05245513
• Other study ID #: 2021P003720
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: February 28, 2027

Study information

• Verified date: February 2024
• Source: Massachusetts General Hospital
• Contact: Lauren A Hoffman, PhD
• Phone: (617) 643-4690
• Email: lhoffman1[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 145
• Est. completion date: February 28, 2027
• Est. primary completion date: February 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall recruitment feasibility	Number of participants successfully recruited within allotted recruitment time frame (~3 years)	Through study completion, ~3 years from recruitment initiation
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Participant retention	Percent of enrolled participants who complete Month 3 Follow-Up	From the date of first participant enrollment in the trial to the date of study completion, up to 42 months
Secondary	Feasibility of peer facilitator meet-ups	Percent of peer facilitator meet-ups occurring within 2 weeks of participant's linkage manager meeting	Month 1; Month 3
Secondary	Intervention appropriateness	Assessed via the Intervention Appropriateness Measure (IAM; adapted for study parameters) average total score. This is a 4-item instrument to assess perceived intervention appropriateness. Items are measured on a 5-point Likert scale (Strongly Disagree-Strongly Agree). Score is the calculated mean. Higher scores indicate greater appropriateness.	Month 1
Secondary	Intervention helpfulness	Assessed via 4 single-item statements addressing the intervention's helpfulness in general and helpfulness to supporting treatment and opioid use disorder recovery. Items are measured on a 6-point Likert scale (Strongly Disagree-Strongly Agree). Score is the response for each item. Higher scores indicate greater helpfulness.	Month 1; Month 3
Secondary	Change in recovery capital from baseline to Month 3	Assessed via the REC-CAP Inventory total score. Scores range from -100 to +100, with higher scores indicating greater recovery capital.	Baseline; Month 1; Month 3