Peer Recovery Coaching for TUDPeerTTSNCT06965153
Peer Recovery Coaching for Tobacco Abstinence in People With Opioid Use Disorder
A study testing Dual NRT and PeerTTS in people with Peer Recovery Coaching for TUD, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Tobacco use is a leading cause of premature death among individuals with opioid use disorder (OUD). Nearly 75% of individuals receiving medication treatment for OUD report concurrent tobacco use disorder (MOUD-TUD), yet evidence-based TUD treatment (i.e., Food and Drug Administration-approved medications and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peer Recovery Coaching for TUD
- What is being tested?
- Dual NRT and PeerTTS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 1 Jan 2028
- 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
- Adults (≥ 18 years of age)
- reporting current daily cigarette smoking (≥ 5 cigarettes per day in past 7 days),
- who are interested in quitting or cutting down on smoking in the next 3 months (yes/no),
- stable on their medication treatment for OUD (MOUD) at MGH (confirmed with patient's buprenorphine prescriber).
Who cannot join
- life expectancies < 1 year (per chart review by physician Co-I) or with any serious psychiatric or cognitive problem that would preclude ability to provide informed consent (i.e., unstable or untreated bipolar disorder, schizophrenia spectrum disorder, psychotic disorder, or actively suicidal)
- participants who have recent unstable cardiovascular or cerebrovascular disease (e.g., recovery phase of acute myocardial infarction, severe cardiac arrhythmias, and cerebrovascular accident; See Human Subjects) per discussion with their MOUD prescriber.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michele Reyen, MPH contact
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Joanna M Streck, PhD, 617-643-9977, jstreck@mgh.harvard.edu
Michele Reyen, MPH, mreyen@mgh.harvard.edu
About this study
Official title: Peer Recovery Coaching for Promoting Tobacco Abstinence in People With Opioid Use Disorder
Tobacco use is a leading cause of premature death among individuals with opioid use disorder (OUD). Nearly 75% of individuals receiving medication treatment for OUD report concurrent tobacco use disorder (MOUD-TUD), yet evidence-based TUD treatment (i.e., Food and Drug Administration-approved medications and counseling) is less effective in those with MOUD-TUD compared to the general smoking population. Innovative interventions for promoting TUD cessation in individuals with MOUD-TUD are urgently needed. Major factors maintaining TUD in those with OUD that have not been addressed in existing treatment interventions in this population are the small social networks comprised of other smokers, pro-smoking social norms in social networks, and limited social support for quitting smoking. Peer recovery coaches (PRCs) are people with lived OUD experience who provide peer coaching to individuals with OUD and have been shown to promote increased OUD treatment retention and illicit opioid abstinence. PRCs who are in OUD-TUD recovery and trained in TUD treatment, are well positioned to provide a social model for nonsmoking and to alter the pro-smoking social norms that maintain TUD in those receiving MOUD; but this has never been tested. The investigators hypothesize that a tobacco cessation intervention, delivered by PRCs in OUD and TUD recovery with TUD training, combined with a safe and effective FDA-approved cessation medication (dual nicotine replacement therapy [NRT]), will be feasible, acceptable and have a greater effect on tobacco abstinence rates than current standard care TUD treatment (non-peer delivered TUD coaching plus dual NRT). To test this hypothesis, in this 3-year pilot R34, the investigators propose to adapt a behavioral TUD intervention, PeerTTS, to people with OUD and TUD and to train PRCs in OUD and TUD recovery to deliver the intervention. The investigative team will then conduct a pilot randomized controlled trial (RCT) in 60 participants with MOUD-TUD interested in reducing or quitting tobacco at MGH. Participants will be randomized to receive 12 weeks of 1) PeerTTS, defined as PRC-delivered tobacco cessation coaching plus dual NRT or 2) standard care (SOC), defined as non-peer delivered TUD coaching plus dual NRT. The proposed work will adapt and test whether a peer recovery coach-delivered tobacco cessation intervention is feasible, acceptable, and potentially more effective than standard care, when combined with first line pharmacotherapy in those with MOUD-TUD. The pilot RCT will provide quantitative and qualitative data to inform a fully powered R01 or equivalent testing a refined version of the PeerTTS intervention for individuals with MOUD-TUD who face a disproportionate burden of tobacco use and related mortality. This proposal aligns with NIDA's high priority research areas to test novel treatments that sustain recovery in individuals with poly-substance use (OUD and TUD) and to advance the science of peer recovery support. It also aligns with calls to enhance PRC training to include additional evidence-based competencies that improve health.
- Conditions
- Peer Recovery Coaching for TUD
- Being tested
- Dual NRT, PeerTTS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual NRTDrug
Dual nicotine replacement therapy
PeerTTSBehavioural
Peer recovery coach delivered tobacco cessation coaching
| Study group | Role | What they receive |
|---|---|---|
| PeerTTS | Experimental | Peer recovery coach-delivered tobacco cessation coaching plus dual NRT Receives: Drug: Dual NRT; Behavioral: PeerTTS |
| SOC | Active comparator | Non-peer delivered tobacco cessation coaching plus dual NRT Receives: Drug: Dual NRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility-PeerTTS session attendance
PeerTTS coaching session attendance
Measured: Baseline through 3 months
Secondary outcomes (2)
Biochemically confirmed past 7-day tobacco abstinence
CO-confirmed abstinence
Measured: 3 months
Acceptability
Client Satisfaction Questionnaire (CSQ-8)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start1 Jun 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peer Recovery Coaching for TUDStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanna M. Streck, Ph.D., Massachusetts General Hospital
- Investigators
- Joanna M Streck, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965153
- Sponsor's protocol ID
- 2025P001024
- Acronym
- PeerTTS
- Status last verified
- Oct 2026
- First submitted
- 1 May 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Recovery Coaching for Promoting Tobacco Abstinence in People With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT06965153
- Acronym / sponsor ID
- PeerTTS / 2025P001024
- Conditions
- Peer Recovery Coaching for TUD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 11 May 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.
Tobacco use is a leading cause of premature death among individuals with opioid use disorder (OUD). Nearly 75% of individuals receiving medication treatment for OUD report concurrent tobacco use disorder (MOUD-TUD), yet evidence-based TUD treatment (i.e., Food and Drug Administration-approved medications and counseling) is less effective in those with MOUD-TUD compared to the general smoking population. Innovative interventions for promoting TUD cessation in individuals with MOUD-TUD are urgently needed. Major factors maintaining TUD in those with OUD that have not been addressed in existing treatment interventions in this population are the small social networks comprised of other smokers, pro-smoking social norms in social networks, and limited social support for quitting smoking. Peer recovery coaches (PRCs) are people with lived OUD experience who provide peer coaching to individuals with OUD and have been shown to promote increased OUD treatment retention and illicit opioid abstinence. PRCs who are in OUD-TUD recovery and trained in TUD treatment, are well positioned to provide a social model for nonsmoking and to alter the pro-smoking social norms that maintain TUD in those receiving MOUD; but this has never been tested. The investigators hypothesize that a tobacco cessation intervention, delivered by PRCs in OUD and TUD recovery with TUD training, combined with a safe and effective FDA-approved cessation medication (dual nicotine replacement therapy [NRT]), will be feasible, acceptable and have a greater effect on tobacco abstinence rates than current standard care TUD treatment (non-peer delivered TUD coaching plus dual NRT). To test this hypothesis, in this 3-year pilot R34, the investigators propose to adapt a behavioral TUD intervention, PeerTTS, to people with OUD and TUD and to train PRCs in OUD and TUD recovery to deliver the intervention. The investigative team will then conduct a pilot randomized controlled trial (RCT) in 60 participants with MOUD-TUD interested in reducing or quitting tobacco at MGH. Participants will be randomized to receive 12 weeks of 1) PeerTTS, defined as PRC-delivered tobacco cessation coaching plus dual NRT or 2) standard care (SOC), defined as non-peer delivered TUD coaching plus dual NRT. The proposed work will adapt and test whether a peer recovery coach-delivered tobacco cessation intervention is feasible, acceptable, and potentially more effective than standard care, when combined with first line pharmacotherapy in those with MOUD-TUD. The pilot RCT will provide quantitative and qualitative data to inform a fully powered R01 or equivalent testing a refined version of the PeerTTS intervention for individuals with MOUD-TUD who face a disproportionate burden of tobacco use and related mortality. This proposal aligns with NIDA's high priority research areas to test novel treatments that sustain recovery in individuals with poly-substance use (OUD and TUD) and to advance the science of peer recovery support. It also aligns with calls to enhance PRC training to include additional evidence-based competencies that improve health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PeerTTS | Experimental | Drug: Dual NRT, Behavioral: PeerTTSPeer recovery coach-delivered tobacco cessation coaching plus dual NRT |
| SOC | Active comparator | Drug: Dual NRTNon-peer delivered tobacco cessation coaching plus dual NRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (≥ 18 years of age)
- reporting current daily cigarette smoking (≥ 5 cigarettes per day in past 7 days),
- who are interested in quitting or cutting down on smoking in the next 3 months (yes/no),
- stable on their medication treatment for OUD (MOUD) at MGH (confirmed with patient's buprenorphine prescriber).
Key exclusion criteria (2 listed)
- life expectancies < 1 year (per chart review by physician Co-I) or with any serious psychiatric or cognitive problem that would preclude ability to provide informed consent (i.e., unstable or untreated bipolar disorder, schizophrenia spectrum disorder, psychotic disorder, or actively suicidal)
- participants who have recent unstable cardiovascular or cerebrovascular disease (e.g., recovery phase of acute myocardial infarction, severe cardiac arrhythmias, and cerebrovascular accident; See Human Subjects) per discussion with their MOUD prescriber.
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 |
|---|---|---|
| Dual NRTDual nicotine replacement therapy | Drug | PeerTTS, SOC |
| PeerTTSPeer recovery coach delivered tobacco cessation coaching | Behavioural | PeerTTS |
Primary outcome
Feasibility-PeerTTS session attendance
Time frame: Baseline through 3 months
PeerTTS coaching session attendance
2 secondary outcomes
Biochemically confirmed past 7-day tobacco abstinence
Time frame: 3 months
Acceptability
Time frame: 3 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 7 Oct 2026.
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.
Michele Reyen, MPH contact
Joanna M Streck, PhD 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 Dual NRT and PeerTTS in people with Peer Recovery Coaching for TUD, 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 2 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: looking for participants now, as of the sponsor's last update on 7 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?
Contact Joanna M Streck, PhD (617-643-9977, jstreck@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility-PeerTTS session attendance (time frame: Baseline through 3 months). 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 7 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.