Opioid Use DisorderNCT05245513
Enhancing Recovery Capital Amid Opioid Use Disorder Pharmacotherapy: A Pilot Randomized Trial
A study testing Recovery Community Center Linkage (RCCL) in people with Opioid Use Disorder, run by Massachusetts General Hospital at 1 site in United States.
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. 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 Linkage (RCCL)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 28 Feb 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
Lauren A Hoffman, PhD, 617-643-4690, lhoffman1@mgh.harvard.edu
About this study
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
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.
Read the 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.
- Conditions
- Opioid Use Disorder
- Being tested
- Recovery Community Center Linkage (RCCL), Control Condition (CC)
- 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 Linkage (RCCL)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Recovery Community Center Linkage (RCCL) | Experimental | 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. Receives: Behavioral: Recovery Community Center Linkage (RCCL) |
| Control Condition (CC) | Active comparator | 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. Receives: Behavioral: Control Condition (CC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall recruitment feasibility
Number of participants successfully recruited within allotted recruitment time frame (~3 years)
Measured: Through study completion, ~3 years from recruitment initiation
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.
Measured: From the date of intervention manual finalization until the date of study completion, assessed up to 48 months
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.
Measured: From date of first linkage manager meeting until the date of last linkage manager meeting, assessed up to 36 months
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.
Measured: Month 1
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.
Measured: Month 1
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
Measured: From the date of linkage manager meeting until the date of month-3 follow up, assessed up to 3 months
Use of recovery support services
Percent days use of any recovery support services post linkage manager meeting, as assessed via the Timeline Follow Back
Measured: From the date of linkage manager meeting until the date of month-3 follow up, assessed up to 3 months
Secondary outcomes (5)
Participant retention
Percent of enrolled participants who complete Month 3 Follow-Up
Measured: From the date of first participant enrollment in the trial to the date of study completion, up to 42 months
Feasibility of peer facilitator meet-ups
Percent of peer facilitator meet-ups occurring within 2 weeks of participant's linkage manager meeting
Measured: Month 1; Month 3
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.
Measured: Month 1
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.
Measured: Month 1; Month 3
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.
Measured: Baseline; Month 1; Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Dec 2025 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Hoffman, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245513
- Sponsor's protocol ID
- 2021P003720
- Status last verified
- Sep 2025
- First submitted
- 4 Feb 2022
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05245513
- Acronym / sponsor ID
- 2021P003720
- Conditions
- Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 18 Feb 2022 (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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recovery Community Center Linkage (RCCL) | Experimental | Behavioral: Recovery Community Center Linkage (RCCL)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. |
| Control Condition (CC) | Active comparator | Behavioral: Control Condition (CC)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 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. | Behavioural | Recovery Community Center Linkage (RCCL) |
| 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. | Behavioural | Control Condition (CC) |
Primary outcome
Overall recruitment feasibility
Time frame: Through study completion, ~3 years from recruitment initiation
Number of participants successfully recruited within allotted recruitment time frame (~3 years)
Overall intervention feasibility
Time frame: From the date of intervention manual finalization until the date of study completion, assessed up to 48 months
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
Time frame: From date of first linkage manager meeting until the date of last linkage manager meeting, assessed up to 36 months
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
Time frame: Month 1
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
Time frame: Month 1
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
Time frame: From the date of linkage manager meeting until the date of month-3 follow up, assessed up to 3 months
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
Time frame: From the date of linkage manager meeting until the date of month-3 follow up, assessed up to 3 months
Percent days use of any recovery support services post linkage manager meeting, as assessed via the Timeline Follow Back
5 secondary outcomes
Participant retention
Time frame: From the date of first participant enrollment in the trial to the date of study completion, up to 42 months
Feasibility of peer facilitator meet-ups
Time frame: Month 1; Month 3
Intervention appropriateness
Time frame: Month 1
Intervention helpfulness
Time frame: Month 1; Month 3
Change in recovery capital from baseline to Month 3
Time frame: Baseline; Month 1; Month 3
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 26 Sep 2025.
- Individual participant dataSharing planned: No
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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.
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 Linkage (RCCL) 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 26 Sep 2025. 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?
Contact Lauren A Hoffman, PhD ((617) 643-4690, lhoffman1@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall recruitment feasibility (time frame: Through study completion, ~3 years from recruitment initiation). The study lists 7 primary outcomes in all. 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 26 Sep 2025.