Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement

Phase 3

Recruiting

• Conditions: Tobacco Use; Polysubstance Abuse; Opioid Use
• Interventions: Other: Support Group and No MI and NRT; Other: MORE and MI and NRT; Other: MORE and No MI and NRT; Other: Support Group and MI and NRT

• Registration Number: NCT06033599
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-05
• Study First Submitted: 2023-09-05
• Study First Submitted QC: 2023-09-05
• Study First Posted: 2023-09-13
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-07
• Last Update Posted: 2023-10-10
• Primary Completion: 2026-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

• English-speaking
• Age ≥18
• Currently on methadone; and 4) currently smoke cigarettes.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Support Group and No MI	Support Group and No MI and NRT	-
MORE and MI	MORE and MI and NRT	-
MORE and No MI	MORE and No MI and NRT	-
Support Group and MI	Support Group and MI and NRT	-

Primary Outcome Measures

Name	Time	Method
Days of Drug Use	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.
Days of Tobacco Use	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.

Trial Locations

Locations (2)

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

University of Utah; 🇺🇸 Salt Lake City, Utah, United States