Towards Testing the Effectiveness of Recovery Community Centers (RCCs)
R34 Study 2 - Pilot RCT Testing the Effectiveness of RCCs
2 other identifiers
interventional
128
1 country
1
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2025
CompletedFirst Posted
Study publicly available on registry
June 8, 2025
CompletedStudy Start
First participant enrolled
August 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 15, 2027
September 26, 2025
July 1, 2025
1 year
May 30, 2025
September 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recruitment Rate
The recruitment rate will be estimated from 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. The recruitment rate will be reported as mean with standard deviation (based on monthly observations) and will be reported descriptively.
Baseline
Secondary Outcomes (4)
Study Withdrawals
1 month
Completion of Recovery Activities
1 month
Completion of Follow-up Surveys
Baseline, 1, 3, 6, and 12 month
Completion of Timeline Follow-Back (TLFB) Interviews
Baseline, 1, 3, 6, and 12 months
Other Outcomes (7)
The Substance Use Recovery Evaluator (SURE)
Baseline, 1, 3, 6, and 12 months
Brief Measure of Recovery (based on SAMHSA's definition of recovery)
Baseline, 1, 3, 6, and 12 months
Experience of Support (Based on SAMHSA's definition of peer support)
Baseline, 1, 3, 6, and 12 months
- +4 more other outcomes
Study Arms (2)
Recovery Community Center (RCC) Linkage
EXPERIMENTALThese participants will be assigned to visit their local recovery community center at least twice, on two different days, within the first month of the study and to report on their RCC visits.
Enhanced Treatment as Usual (ETAU)
ACTIVE COMPARATORThese participants will be asked to complete any recovery activity of their choosing at least twice, on two different days, within the first month of the study and to report on their chosen recovery activities.
Interventions
Recovery community centers are brick and mortar buildings that house recovery-oriented organizations, located in the heart of their communities. They act as recovery hubs, offering a variety of recovery support services in house as well as connecting participants to resources in their area. They are peer-led organizations that are open to anyone in early or long-term recovery from substance use and that recognize that there are multiple pathways to recovery. Study participants will be provided with information about their local RCC (including a video link, contact information, a monthly calendar of events, a list of services and activities offered by the RCC, transportation options, etc.) and will be asked to visit the RCC on two different occasions within one month of enrollment.
In this study, the enhanced treatment as usual intervention will encompass providing participants with information about diverse recovery activities (e.g., mutual help group meetings, exercise, job search, recovery coach meetings, etc.) and then to assign participants to complete a recovery activity of their choosing one two different days within one month after enrollment. Participants can do the same activity twice, or different activities on each of the two days assigned.
Eligibility Criteria
You may qualify if:
- + 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
You may not qualify if:
- \- Has visited a vetted RCC during the past 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bettina Hoeppner, Ph.D., M.S.
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
May 30, 2025
First Posted
June 8, 2025
Study Start
August 20, 2025
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
April 15, 2027
Last Updated
September 26, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- The investigators will provide de-identified data from this project to interested individuals for one year following achievement of the aims of the project (i.e., publication of the main outcome papers).
- Access Criteria
- Data sharing will be contingent on meeting all institutional regulations for data use agreements and on receiving evidence of the recipient's institution's IRB approval for planned analyses of the data. Interested parties requesting data will receive the requested data needed to execute their analysis plan in accordance with these approvals. The IPD will be provided in digital format with clear labels for all variables, will be de-identified before it is shared, and will be released directly by the investigators to the recipients with secure data transfer. Regarding supporting information, the final version of the study protocol (including the statistical analysis plan (SAP)) and the final version of the Informed Consent Form (ICF) will be made publicly available in this clinicaltrials.gov record. Additional supporting information, including analytic code, will be made available upon a specific request to the investigative team.
The investigators will provide de-identified IPD related to the aims, baseline demographics, and outcomes described in this study record to interested individuals one year following achievement of the aims of the project (i.e., publication of the main outcome papers). Data sharing will be contingent on meeting all institutional regulations for data use agreements and on receiving evidence of the recipient's institution's IRB approval for planned analyses of the data. The investigator team will be available to address queries.