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Not yet recruitingNCT07931430SUPPORTUpdated Nov 12, 2026

Peer Recovery Support in the Homeless Health Care Setting

An interventional study of Peer support in Opioid Use Disorder, sponsored by Massachusetts General Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Opioid-Related Disorders by Massachusetts General Hospital — 3 open to participants now, 4 under way, none of them phase 3. Opioid-Related Disorders · Massachusetts General Hospital.

Planned enrollment
8th of 10
40 · median 68
Started
2026
the only one that year
No phase
6 of 10
3 open now
Registered
10th of 10
by date

Among the 10 studies in Opioid-Related Disorders by Massachusetts General Hospital, this one is the 8th largest by planned enrollment, is the only one that started in 2026, is one of 6 with no phase, and was the 10th registered.

Opioid-Related Disorders

1,473 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

Browse Opioid-Related Disorders studies →

Open to participants now

3 of the 10 studies in Opioid-Related Disorders by Massachusetts General Hospital are open now, in 2 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Where they have run

Who these studies take

Of the 209 Opioid-Related Disorders studies recruiting now, 122 (58%) set no upper age limit and 73 (35%) stop at 75 or younger; 14 take children under 18; 52 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies in Opioid-Related Disorders by Massachusetts General Hospital, or all of them as a file.
02

Study summary

The goal of this clinical trial is to learn whether a peer recovery support program designed for people experiencing homelessness can be successfully delivered as part of opioid use disorder treatment. Peer recovery support specialists are individuals who use their personal experience with substance use and recovery to support others. The main questions this pilot study aims to answer are:

  • Is it feasible to conduct the study and deliver the peer recovery support program?
  • Is the program acceptable to participants?
  • Can the program be delivered as intended?
  • Does the program show promise for helping participants stay engaged in opioid use disorder treatment?

Researchers will compare participants who receive peer recovery support in addition to usual opioid use disorder treatment with participants who receive usual treatment alone.

Participants will:

  • Be randomly assigned to one of the two study groups.
  • Complete a survey when they enroll and another survey approximately 3 months later.
  • If assigned to the peer recovery support group, be offered individualized support from a peer recovery support specialist for 3 months, with meetings approximately weekly.
  • If assigned to the peer recovery support group, complete an interview at the end of the study about their experiences with the program.
Read the detailed description

### Study Rationale

Developing effective strategies to improve opioid use disorder (OUD) treatment retention among people experiencing homelessness (PEH) is important to reducing mortality in this high-risk population. Evidence from general OUD treatment settings suggests that peer recovery support services may improve treatment engagement and outcomes. Peer recovery support may be particularly beneficial for PEH, who often experience adverse social determinants of health, have limited social support, and face challenges navigating health care and social service systems.

The investigators developed a peer recovery support intervention tailored to the homeless health care setting, informed by patient focus groups, interviews with key informants from Health Care for the Homeless programs, and a community-engaged modified Delphi process.

### Study Objectives

The objective of this randomized pilot trial is to evaluate a 90-day peer recovery support intervention designed to improve OUD treatment retention among PEH. The primary objectives are to assess the feasibility of study procedures, intervention feasibility and acceptability, and intervention fidelity. Secondary objectives include exploring preliminary differences in OUD treatment retention and other clinical and psychosocial outcomes between study arms. Findings will inform intervention refinement and the design of a future, larger randomized controlled trial.

### Study Design and Setting

This study is a two-arm randomized pilot trial involving 40 adults with OUD initiating a new treatment episode at the Boston Health Care for the Homeless Program (BHCHP) office-based addiction treatment (OBAT) program at Jean Yawkey Place in Boston, Massachusetts.

Potential participants will be identified through collaboration with OBAT clinicians and staff and through electronic health record reports identifying patients initiating a new OBAT treatment episode. Interested individuals will undergo eligibility screening and informed consent within 7 days of their initial OBAT visit.

Following informed consent, participants will be randomized in a 1:1 ratio to receive either usual OBAT care (n=20) or peer recovery support in addition to usual OBAT care (n=20). Randomization will be conducted using REDCap. Study assignment will be concealed from participants until completion of the baseline survey.

### Study Procedures

Participants in both study arms will complete a baseline survey and a 90-day follow-up survey. Surveys will assess substance use, mental health, social support, and other factors potentially associated with OUD treatment engagement.

Following completion of the baseline survey, participants will be informed of their study assignment. Participants randomized to the intervention arm will be introduced to the peer recovery support specialist through a warm handoff whenever feasible. When an in-person introduction is not possible, the peer recovery support specialist will initiate outreach following enrollment.

Participants randomized to the usual care arm will continue to receive standard OBAT care without the addition of study-provided peer recovery support services.

### Peer Recovery Support Intervention

Participants randomized to the intervention arm will be offered 90 days of individualized support from a peer recovery support specialist in addition to usual OBAT care. The intervention is grounded in principles of harm reduction and patient-centered care, with an emphasis on developing trusting relationships and addressing barriers to OUD treatment engagement.

During the intervention period, the peer recovery support specialist will aim to meet with participants approximately weekly. The frequency, timing, duration, and content of sessions will be tailored to participants' needs, preferences, and availability. Additional contacts or meetings may occur as needed. Sessions may take place in person, by telephone, or by videoconference, with in-person meetings encouraged when feasible. Text messaging may also be used for communication and coordination with participants who provide consent.

Intervention activities may include emotional and recovery support, assistance navigating health care and social service systems, development of recovery-related skills and goals, and connections to treatment and community resources. The specific support provided will be individualized based on each participant's needs and goals.

Participants without access to a mobile phone will be provided with a phone and prepaid service to facilitate communication with the peer recovery support specialist.

Throughout the intervention period, the peer recovery support specialist will meet approximately weekly with an experienced supervisor to review intervention delivery, participant engagement, peer support boundaries, and challenging situations. Additional supervision will be available as needed.

The peer recovery support specialist will document all participant contacts and outreach attempts using standardized forms in REDCap. Documentation will include the frequency, duration, and mode of contact, as well as intervention components delivered. These data will be used to assess intervention delivery and fidelity.

At the conclusion of the 90-day intervention period, the peer recovery support specialist will work with participants, as appropriate, to identify ongoing sources of peer, clinical, or community support.

### Follow-up and Data Collection

Participants in both study arms will be invited to complete a follow-up survey between 90 and 105 days after randomization. Follow-up assessments may be completed in person or by telephone.

Participants randomized to the intervention arm will also be invited to complete a qualitative exit interview lasting approximately 45-60 minutes. Interviews will explore participants' experiences with the intervention, including its acceptability, perceived benefits, fit with participants' needs, and implementation. Interviews will be audio-recorded for qualitative analysis.

Electronic health record data will also be collected to assess OUD treatment engagement and retention during the study period. These data, together with participant surveys, intervention documentation, and qualitative interviews, will be used to evaluate the pilot trial objectives.

03

Conditions studied

  • Opioid Use Disorder
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged at least 18 years
  • Proficient in English
  • Diagnosis of opioid use disorder, assessed by the clinical provider and documented within the patient's EHR
  • New OBAT treatment episode, defined as having had no clinical encounters in the OBAT program during the prior 60 days

Exclusion criteria

Exclusion Criteria:

  • Inability to demonstrate adequate understanding of the information
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • No intervention
    Usual OBAT Care

    Participants in this arm will receive usual OBAT care

  • Experimental
    Peer support

    Participants in this arm will receive usual OBAT care and additional support from a peer recovery support specialist

    Behavioral: Peer support

Interventions

  • BehavioralPeer support

    Participants assigned to the intervention arm will be offered 90 days of individualized peer recovery support in addition to usual office-based addiction treatment (OBAT) care. The peer recovery support specialist will aim to meet with participants approximately weekly over the intervention period. The frequency, duration, timing, and content of meetings will be tailored to participants' needs and preferences, with additional contacts available as needed. Meetings may take place in person, by telephone, or by videoconference. Intervention activities may include emotional and recovery support, assistance navigating health care and social service systems, development of recovery-related skills and goals, and linkage to treatment and community resources. Participants without access to a mobile phone will be provided with a phone and prepaid service to facilitate communication with the peer recovery support specialist.

06

What researchers measure

Primary outcomes

  1. Recruitment rate

    Proportion of eligible individuals who enroll in the study, calculated as the number of enrolled participants divided by the number of eligible individuals screened.

    Time frame: During recruitment period

  2. Randomization rate

    Proportion of enrolled participants who are successfully randomized to a study arm, calculated as the number of randomized participants divided by the total number enrolled.

    Time frame: At enrollment

  3. Study retention rate

    Proportion of randomized participants who complete the 90-day follow-up survey, calculated as the number completing the follow-up survey divided by the total number randomized.

    Time frame: 90-day follow-up (days 90-105 after randomization).

  4. Client Satisfaction Questionnaire Score

    Intervention acceptability will be assessed among participants randomized to the peer recovery support intervention using the 8-item Client Satisfaction Questionnaire (CSQ-8). Scores range from 8 to 32, with higher scores indicating greater satisfaction with services received.

    Time frame: 90-day follow-up (days 90-105 after randomization)

  5. Number of Completed Peer Support Sessions

    Total number of completed peer support sessions per intervention participant during the 90-day period.

    Time frame: Randomization through day 90

Secondary outcomes

  1. Retention in Office-Based Addiction Treatment (OBAT) at 90 Days

    Proportion of participants with at least one completed in-person or virtual OBAT clinical encounter between days 75 and 105 following the baseline visit, assessed using electronic health record data.

    Time frame: Days 75-105 following enrollment

  2. Self-Reported Buprenorphine Adherence

    Number of days covered by buprenorphine during the 30 days preceding the 90-day follow-up, assessed using the Timeline Followback (TLFB) method. Possible values range from 0 to 30 days, with higher values indicating greater medication coverage.

    Time frame: Past 30 days at the 90-day follow-up

  3. Buprenorphine Percent of Days Covered

    Percentage of days covered by buprenorphine during the 90-day study period, calculated using electronic health record medication data. Values range from 0% to 100%, with higher values indicating greater medication coverage.

    Time frame: Enrollment through day 90

  4. Past 30-Day Non-Prescribed Opioid Use

    Number of days of non-prescribed opioid use during the 30 days preceding the 90-day follow-up, assessed using the Timeline Followback (TLFB) method. Possible values range from 0 to 30 days, with higher values indicating more frequent opioid use.

    Time frame: Past 30 days at the 90-day follow-up.

  5. Change in Opioid Use Severity

    Change in opioid use severity from baseline to the 90-day follow-up, assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS)-based opioid use severity score. Higher scores indicate greater opioid use severity.

    Time frame: Baseline and 90-day follow-up

  6. Change in Recovery

    Change in recovery from baseline to the 90-day follow-up, assessed using the Substance Use Recovery Evaluator (SURE) total score. Higher scores indicate greater recovery.

    Time frame: Baseline and 90-day follow-up

  7. Change in Emotional Support

    Change in perceived emotional support from baseline to the 90-day follow-up, assessed using the 4-item PROMIS Emotional Support Short Form. Higher scores indicate greater perceived emotional support.

    Time frame: Baseline and 90-day follow-up

  8. Change in Instrumental Support

    Change in perceived instrumental support from baseline to the 90-day follow-up, assessed using the 4-item PROMIS Instrumental Support Short Form. Higher scores indicate greater perceived instrumental support.

    Time frame: Baseline and 90-day follow-up

  9. Change in Informational Support

    hange in perceived informational support from baseline to the 90-day follow-up, assessed using the 4-item PROMIS Informational Support Short Form. Higher scores indicate greater perceived informational support.

    Time frame: Baseline and 90-day follow-up

  10. Change in Companionship

    Change in perceived companionship from baseline to the 90-day follow-up, assessed using the 4-item PROMIS Companionship Short Form. Higher scores indicate greater perceived companionship.

    Time frame: Baseline and 90-day follow-up

Other outcomes

  1. Duration of Peer Support Sessions

    Duration in minutes of completed peer support sessions, summarized across intervention participants.

    Time frame: Randomization through day 90

  2. Delivery of Intervention Components

    Frequency with which prespecified peer support intervention components are documented as delivered, based on the Peer Support Contact and Fidelity Log.

    Time frame: Randomization through day 90

07

Study locations

No study locations are listed for this record.

08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Sep 2027, 9 months later.

Of 464 non-industry interventional studies with no phase under Opioid-Related Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 47. This study's planned 9 months is below that.

Counting every sponsor, half of 495 studies reached it within 29 months; a quarter within 13 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2026
First posted
Nov 12, 2026
StartEst.
Dec 15, 2026
Primary completionEst.
Sep 15, 2027
CompletionEst.
Sep 15, 2027
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07931430
Responsible party
Danielle, Fine (Physician Investigator, Massachusetts General Hospital) — Principal investigator
First posted
Nov 12, 2026
Start date
Dec 15, 2026 (estimated)
Primary completion
Sep 15, 2027 (estimated)
Completion
Sep 15, 2027 (estimated)
Last update
Nov 12, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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