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Recruiting

NCT Number: NCT06033599

Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement

The purpose of this study is to 1) examine barriers and facilitators to implementation of MI and MORE for polysubstance use and evaluate strategies for optimizing training, fidelity, and clinic uptake, and 2) evaluate patient outcomes related to the effectiveness of MORE decreasing opioid, tobacco, and other drug use.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MORE and MI and NRT

Other

Eight group Mindfulness Oriented Recovery Enhancement sessions and one motivational interviewing session and nicotine replacement therapy.

MORE and No MI and NRT

Other

Eight group Mindfulness Oriented Recovery Enhancement sessions and nicotine replacement therapy.

Support Group and MI and NRT

Other

Eight group support group sessions and one motivational interviewing session and nicotine replacement therapy.

Support Group and No MI and NRT

Other

Eight group support group sessions and and nicotine replacement therapy.

Primary outcomes

  1. Days of Drug Use

    Time frame: Baseline through 52 weeks.

    Number of days of drug use as measured by self-reported days of use and biochemically verified use via drug screen.

  2. Days of Tobacco Use

    Time frame: Baseline through 52 weeks.

    Number of days of tobacco use as measured by self-reported days of use and biochemically verified use via expired carbon monoxide.

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Garland, PhD

CONTACT

[email protected]

801-581-3826

Nina Cooperman, PsyD

CONTACT

[email protected]

732-235-8569

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • University of Utah

Registry information

Official study title

Motivational Interviewing (MI) and Mindfulness-Oriented Recovery Enhancement (MORE) for Tobacco Dependence and Other Drug Use in Methadone Treatment

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Sep 13, 2023
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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