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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Joanna M Streck, PhD contact

617-643-9977

jstreck@mgh.harvard.edu

Michele Reyen, MPH contact

MREYEN@mgh.harvard.edu

United States1 site, 1 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

    Recruiting

Other trials in United States

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.

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 groups in NCT06965153
Study groupRoleWhat they receive
PeerTTSExperimentalPeer recovery coach-delivered tobacco cessation coaching plus dual NRT
Receives: Drug: Dual NRT; Behavioral: PeerTTS
SOCActive comparatorNon-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.

  1. Feasibility-PeerTTS session attendance

    PeerTTS coaching session attendance

    Measured: Baseline through 3 months

Secondary outcomes (2)
  1. Biochemically confirmed past 7-day tobacco abstinence

    CO-confirmed abstinence

    Measured: 3 months

  2. 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.

  1. First posted11 May 2025
  2. Study start1 Jun 2026
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion1 Jan 2028 (estimated)

Resources

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)
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

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.

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