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

Primary Purpose

Opioid Use Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Recovery Community Center Linkage (RCCL)
Control Condition (CC)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Opioid Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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
  • within ~1 year of initiating the current buprenorphine treatment episode

Exclusion Criteria:

  • non-English fluency
  • active suicidality
  • neurodevelopmental disorders or neural trauma preventing informed consent
  • active psychosis

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Recovery Community Center Linkage (RCCL)

Control Condition (CC)

Arm 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.

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.

Outcomes

Primary Outcome Measures

Overall recruitment feasibility
Number of participants successfully recruited within allotted recruitment time frame (~3 years)
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.
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.
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.
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.
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
Use of recovery support services
Percent days use of any recovery support services post linkage manager meeting, as assessed via the Timeline Follow Back

Secondary Outcome Measures

Participant retention
Percent of enrolled participants who complete Month 3 Follow-Up
Feasibility of peer facilitator meet-ups
Percent of peer facilitator meet-ups occurring within 2 weeks of participant's linkage manager meeting
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.
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.
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.

Full Information

First Posted
February 4, 2022
Last Updated
September 7, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05245513
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 15, 2023 (Anticipated)
Primary Completion Date
February 28, 2027 (Anticipated)
Study Completion Date
February 28, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
145 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recovery Community Center Linkage (RCCL)
Arm Type
Experimental
Arm 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.
Arm Title
Control Condition (CC)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Recovery Community Center Linkage (RCCL)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Condition (CC)
Intervention Description
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 Measure Information:
Title
Overall recruitment feasibility
Description
Number of participants successfully recruited within allotted recruitment time frame (~3 years)
Time Frame
Through study completion, ~3 years from recruitment initiation
Title
Overall intervention feasibility
Description
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.
Time Frame
From the date of intervention manual finalization until the date of study completion, assessed up to 48 months
Title
Fidelity: Linkage manager adherence
Description
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.
Time Frame
From date of first linkage manager meeting until the date of last linkage manager meeting, assessed up to 36 months
Title
Overall intervention acceptability
Description
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.
Time Frame
Month 1
Title
Overall intervention satisfaction
Description
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.
Time Frame
Month 1
Title
Recovery community center attendance
Description
Percent of participants who attended a recovery community center 1+ time post linkage manager meeting, as assessed via the Timeline Follow Back
Time Frame
From the date of linkage manager meeting until the date of month-3 follow up, assessed up to 3 months
Title
Use of recovery support services
Description
Percent days use of any recovery support services post linkage manager meeting, as assessed via the Timeline Follow Back
Time Frame
From the date of linkage manager meeting until the date of month-3 follow up, assessed up to 3 months
Secondary Outcome Measure Information:
Title
Participant retention
Description
Percent of enrolled participants who complete Month 3 Follow-Up
Time Frame
From the date of first participant enrollment in the trial to the date of study completion, up to 42 months
Title
Feasibility of peer facilitator meet-ups
Description
Percent of peer facilitator meet-ups occurring within 2 weeks of participant's linkage manager meeting
Time Frame
Month 1; Month 3
Title
Intervention appropriateness
Description
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.
Time Frame
Month 1
Title
Intervention helpfulness
Description
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.
Time Frame
Month 1; Month 3
Title
Change in recovery capital from baseline to Month 3
Description
Assessed via the REC-CAP Inventory total score. Scores range from -100 to +100, with higher scores indicating greater recovery capital.
Time Frame
Baseline; Month 1; Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren A Hoffman, PhD
Phone
(617) 643-4690
Email
lhoffman1@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
John F Kelly, PhD
Phone
(617) 643-1980
Email
jkelly11@mgh.harvard.edu
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren A Hoffman, PhD
Phone
617-643-4690
Email
lhoffman1@mgh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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