Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement

April 27, 2026 updated by: Nina A. Cooperman, Psy. D., Rutgers, The State University of New Jersey

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

420

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Robert Wood Johnson Medical School
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MORE and MI
Other: MORE and MI and NRT
Eight group Mindfulness Oriented Recovery Enhancement sessions and one motivational interviewing session and nicotine replacement therapy.
Experimental: MORE and No MI
Other: MORE and No MI and NRT
Eight group Mindfulness Oriented Recovery Enhancement sessions and nicotine replacement therapy.
Active Comparator: Support Group and MI
Other: Support Group and MI and NRT
Eight group support group sessions and one motivational interviewing session and nicotine replacement therapy.
Active Comparator: Support Group and No MI
Other: Support Group and No MI and NRT
Eight group support group sessions and and nicotine replacement therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline through 52 weeks.
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.
Baseline through 52 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Institute on Drug Abuse (NIDA)
University of Utah

Investigators

  • Principal Investigator: Nina Cooperman, PsyD, Rutgers Robert Wood Johnson Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2022001551
  • R01DA057631 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All participant individual data will be available after de-identification.

IPD Sharing Time Frame

Data will be available three months through five years after study publication

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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