Opioid Use DisorderNCT07010978
Towards Testing the Effectiveness of Recovery Community Centers (RCCs)
A study testing Recovery Community Center Participation and Enhance Treatment as Usual in people with Opioid Use Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Recovery Community Center Participation and Enhance Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2025to 29 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Has visited a vetted RCC during the past 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: R34 Study 2 - Pilot RCT Testing the Effectiveness of RCCs
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:
- Is it feasible to recruit and randomize people to both treatment groups?
- Does linking people to recovery community centers lead to better recovery outcomes?
Read more
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.
Read the 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)).
- Conditions
- Opioid Use Disorder
- Being tested
- Recovery Community Center Participation, Enhance Treatment as Usual
- Keywords
- opioid use disorder, moud, medications for opioid use disorder, recovery, recovery community centers
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery Community Center ParticipationBehavioural
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.
Enhance Treatment as UsualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Recovery Community Center (RCC) Linkage | Experimental | These 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. Receives: Behavioral: Recovery Community Center Participation |
| Enhanced Treatment as Usual (ETAU) | Active comparator | These 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. Receives: Behavioral: Enhance Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (4)
Study Withdrawals
Study withdrawals (i.e., participant-initiated withdrawals from the study after they learn about their randomized treatment assignment) will be reported as the number and percent of participants withdrawing.
Measured: 1 month
Completion of Recovery Activities
To assess the completion rate of assigned recovery activities, we will ask participants to report whether they completed (=1) or did not complete (=0) each of the two recovery activities they will schedule with study staff after enrollment. Completion rates will be presented as the number and percent of participants completing the first or second recovery activity, respectively.
Measured: 1 month
Completion of Follow-up Surveys
To assess completion of study assessments, we will check whether participants completed (including partial completions) (=1) or did not complete (=0) follow-up surveys at each assessment time point. Completion rates will be reported as the number and percent of participants completing them.
Measured: Baseline, 1, 3, 6, and 12 month
Completion of Timeline Follow-Back (TLFB) Interviews
As part of assessing completion of study assessments, we will assess whether study participants completed the Timeline Follow-Back (TLFB) interview (=1) or not (=0) at each assessment time point. In the TLFB interviews, we will ask participants to go back through the last 30 days and report on specific recovery or substance use behaviors. For recovery supports, we will ask participants to tell us on which days they used medications for opioid use disorder or visited their local recovery community center. For substance use, we will ask participants about any non-prescribed opioid use, such as heroin or fentanyl, prescription opioids use without having a prescription for them, and any alcohol use. Completion of TLFB interviews will be reported as number and percent of participants completing them at each assessment point.
Measured: Baseline, 1, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start20 Aug 2025
- Primary completion29 Sep 2027 (estimated)
- Study completion29 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- remote, randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Bettina B. Hoeppner, Massachusetts General Hospital
- Investigators
- Bettina Hoeppner, Ph.D., M.S., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010978
- Sponsor's protocol ID
- 2025P001189
- Other IDs
- 1R34DA057604-01
- Status last verified
- Oct 2026
- First submitted
- 30 May 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- R34 Study 2 - Pilot RCT Testing the Effectiveness of RCCs
- ClinicalTrials.gov ID
- NCT07010978
- Acronym / sponsor ID
- 2025P001189
- Conditions
- Opioid Use Disorder
- Keywords
- opioid use disorder, moud, medications for opioid use disorder, recovery, recovery community centers
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 29 Sep 2027 (estimated)
- Study completion
- 29 Sep 2027 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is it feasible to recruit and randomize people to both treatment groups?
- 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)).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- remote, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Recovery Community Center (RCC) Linkage | Experimental | Behavioral: Recovery Community Center ParticipationThese 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 comparator | Behavioral: Enhance Treatment as UsualThese 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Has visited a vetted RCC during the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recovery Community Center ParticipationRecovery 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. | Behavioural | Recovery Community Center (RCC) Linkage |
| Enhance Treatment as UsualIn 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. | Behavioural | Enhanced Treatment as Usual (ETAU) |
Primary outcome
Recruitment Rate
Time frame: Baseline
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.
4 secondary outcomes
Study Withdrawals
Time frame: 1 month
Completion of Recovery Activities
Time frame: 1 month
Completion of Follow-up Surveys
Time frame: Baseline, 1, 3, 6, and 12 month
Completion of Timeline Follow-Back (TLFB) Interviews
Time frame: Baseline, 1, 3, 6, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bettina Hoeppner, Ph.D., M.S. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery Community Center Participation and Enhance Treatment as Usual in people with Opioid Use Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.