Recruiting
Phase 3

Motivational Interviewing & Mindfulness-Oriented Recovery Enhancement

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT06033599

Conditions

Polysubstance Abuse

Opioid Use

Tobacco Use

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MORE and MI and NRT

MORE and No MI and NRT

Support Group and MI and NRT

Support Group and No MI and NRT

Study Details

Brief summary:

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.

Conditions

Polysubstance Abuse

Opioid Use

Tobacco Use

Study ID

NCT06033599

Start date

Sep 5, 2023

Status verified date

Jul, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

420 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MORE and MI

experimental: MORE and No MI

active comparator: Support Group and MI

active comparator: Support Group and No MI

Interventions

MORE and MI and NRT

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

MORE and No MI and NRT

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

Support Group and MI and NRT

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

Support Group and No MI and NRT

Eight group support group sessions and and nicotine replacement therapy.

Primary outcome measure

  • Days of Drug Use [ Time Frame: Baseline through 52 weeks. ]
  • Days of Tobacco Use [ Time Frame: Baseline through 52 weeks. ]

Central Contacts and Locations

Central contacts

Nina Cooperman, PsyD

732-235-8569cooperna@rwjms.rutgers.edu

Eric Garland, PhD

801-581-3826eric.garland@socwk.utah.edu

Locations

Rutgers Robert Wood Johnson Medical School

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Nina Cooperman

7322358569cooperna@rwjms.rutgers.edu

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Eric Garland, PhD

(801) 581-3826Eric.Garland@socwk.utah.edu

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-07-17.