Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement

Rutgers The State University of New Jersey

Status and phase: Enrolling; Phase 3

Conditions: Polysubstance Abuse; Opioid Use; Tobacco Use

Treatments: Other: MORE and MI and NRT; Other: Support Group and No MI and NRT; Other: MORE and No MI and NRT; Other: Support Group and MI and NRT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06033599

Pro2022001551

R01DA057631 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 420 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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420 participants in 4 patient groups

MORE and MI

Experimental group

Treatment:

Other: MORE and MI and NRT

MORE and No MI

Experimental group

Treatment:

Other: MORE and No MI and NRT

Support Group and MI

Active Comparator group

Treatment:

Other: Support Group and MI and NRT

Support Group and No MI

Active Comparator group

Treatment:

Other: Support Group and No MI and NRT