Clinical trial NCT07010978: Towards Testing the Effectiveness of Recovery Community Centers (RCCs)
Official title: R34 Study 2 - Pilot RCT Testing the Effectiveness of RCCs
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Keywords: opioid use disorder
moud
medications for opioid use disorder
recovery
recovery community centers
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-06-08
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: remote, randomized clinical trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this pilot randomized clinical trial is to prepare for a larger randomized clinical trial (RCT) and collect some early data to learn if the intervention can help people who use medications for opioid use disorder (MOUD). The main questions it aims to answer are:

1. Is it feasible to recruit and randomize people to both treatment groups?
2. Does linking people to recovery community centers lead to better recovery outcomes?

Researchers will compare linking people to recovery community centers (RCC) to enhanced treatment as usual to see if recovery outcomes are different.

In one group, participants will learn about their local RCC and will be asked to visit their local RCC on at least two days and write about their experiences. In the other group, participants will learn about different recovery activities, pick any two, and do the activities of their choice on at least two days. They will also be asked to write about their experiences.

People in both groups will answer online survey questions about their recovery outcomes and well-being in five surveys over one year.

Detailed description: The goal of this study is to prepare for a large-scale RCT. The current study is a pilot randomized clinical trial (RCT) comparing RCC linkage vs. enhanced treatment as usual (ETAU). Persons engaged in MOUD clinical care (n=128) at MOUD-providing clinics near RCCs serving Black communities will be recruited nationwide. The aims of this study are:

Aim 1: Determine the number of study participants enrolled per month. This information will be used for planning a subsequent R01, in line with the goals of the R34 mechanism used to fund this study.

Aim 2: Determine the feasibility of the chosen randomization procedures and groups in terms of (a) study enrollment, (b) completion of recovery activity assignments, and (c) completion of follow-up assessments.

Exploratory Aim 3: Estimate the size of treatment group differences on recovery outcomes over time, including on (a) the Substance Use Recovery Evaluator (SURE); (b) the Brief Measure of Recovery (BMR-4; derived from the Substance Abuse and Mental Health Services Administration's (SAMHSA) definition of recovery); (c) Experience Of Support (derived from SAMHSA goals of peer recovery support services); (d) Brief Assessment of Recovery Capital (BARC-10); and (e) self-report of participation in recovery support services.

Of note, this is a community-engaged research project, involving three community partners (i.e., the Detroit Recovery Project (DRP), Northern Ohio Recovery Association (NORA), and Let's Talk Safety (PILLARS)).

Eligibility criteria: Inclusion Criteria:

* 18+ years of age
* Uses MOUD (at enrollment; participants may stop using MOUD subsequently) to treat OUD
* Receives MOUD from a clinic/pharmacy located within 15 miles of an RCC vetted by our study team, which serves a Black community (i.e., defined as being located in a ZIP code where ≥27% of the residents are Black, as per US Census)
* Is willing and able to engage in study procedures (i.e., online surveys, timeline follow back interview)
* Is willing to be randomized

Exclusion Criteria:

- Has visited a vetted RCC during the past 3 months

Primary outcomes:
measure: Recruitment Rate
timeFrame: Baseline
Secondary outcomes:
measure: Study Withdrawals
timeFrame: 1 month
measure: Completion of Recovery Activities
timeFrame: 1 month
measure: Completion of Follow-up Surveys
timeFrame: Baseline, 1, 3, 6, and 12 month
measure: Completion of Timeline Follow-Back (TLFB) Interviews
timeFrame: Baseline, 1, 3, 6, and 12 months
Other outcomes:
measure: The Substance Use Recovery Evaluator (SURE)
timeFrame: Baseline, 1, 3, 6, and 12 months
measure: Brief Measure of Recovery (based on SAMHSA's definition of recovery)
timeFrame: Baseline, 1, 3, 6, and 12 months
measure: Experience of Support (Based on SAMHSA's definition of peer support)
timeFrame: Baseline, 1, 3, 6, and 12 months
measure: The Brief Assessment of Recovery Capital (BARC-10)
timeFrame: Baseline, 1, 3, 6, and 12 months
measure: Participation in Recovery Support Services
timeFrame: Baseline, 1, 3, 6, and 12 months
measure: The Generalized Anxiety Disorder Screener (GAD-7)
timeFrame: Baseline, 1, 3, 6, and 12 months
measure: The Patient Health Questionnaire for Depression (PHQ-8)
timeFrame: Baseline, 1, 3, 6, and 12 months
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Bettina Hoeppner, Ph.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References: