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New study tests mindfulness and motivation to help methadone patients kick multiple habits

NCT ID NCT06033599

Disease control Sponsor: Rutgers, The State University of New Jersey Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This study is testing two counseling approaches—Motivational Interviewing (MI) and Mindfulness-Oriented Recovery Enhancement (MORE)—to help people on methadone treatment reduce their use of tobacco, opioids, and other drugs. Researchers will enroll 420 adults who are currently on methadone and smoke cigarettes. The goal is to see if these therapies can improve health outcomes and be easily used in clinics.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 420 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * English-speaking * Age ≥18 * Currently on methadone; and 4) currently smoke cigarettes. Exclusion Criteria: * Severe cognitive impairment (score \>23 on Mini Mental Status Exam) or psychosis (positive SCID Psychotic Screen) * Suicidal risk (score ≥7 on Suicidal Behaviors Questionnaire) * Inability to attend or fully participate in intervention sessions or assessments * Previous formal mindfulness training (e.g., MBSR, MBRP) or MORE (from the R21 or R33 * Currently taking smoking cessation pharmacotherapy or participating in smoking cessation counseling * Any contraindications for NRT * Currently or soon planning to be pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

nicotine dependence opiate dependence opioid abuse polysubstance abuse, susceptibility to Tobacco Use

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Opioid use Polysubstance abuse Tobacco use

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Rutgers Robert Wood Johnson Medical School

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84108, United States

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