Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement

Sponsor

Rutgers, The State University of New Jersey (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06033599

Collaborator

University of Utah (Other), National Institute on Drug Abuse (NIDA) (NIH)

420

Enrollment

Arms

45.8

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polysubstance Abuse Opioid Use Tobacco Use	Other: MORE and MI and NRT Other: MORE and No MI and NRT Other: Support Group and MI and NRT Other: Support Group and No MI and NRT	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

420 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 5, 2023

Anticipated Primary Completion Date :

Jun 30, 2026

Anticipated Study Completion Date :

Jun 30, 2027

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. English-speaking; 2) age ≥18; 3) currently on methadone; and 4) currently smoke cigarettes.

Exclusion Criteria:

1. severe cognitive impairment (score >23 on Mini Mental Status Exam)76 or psychosis (positive SCID Psychotic Screen),77 2) suicidal risk (score ≥7 on Suicidal Behaviors Questionnaire),78 3) inability to attend or fully participate in intervention sessions or assessments, 4) previous formal mindfulness training (e.g., MBSR, MBRP) or MORE (from the R21 or R33 studies), 5) currently taking smoking cessation pharmacotherapy or participating in smoking cessation counseling, 6) any contraindications for NRT, and 7) currently or soon planning to be pregnant or breastfeeding.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Rutgers, The State University of New Jersey
University of Utah
National Institute on Drug Abuse (NIDA)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nina A. Cooperman, Psy. D., Associate Professor, Rutgers, The State University of New Jersey

ClinicalTrials.gov Identifier:

NCT06033599

Other Study ID Numbers:

Pro2022001551
R01DA057631

First Posted:

Sep 13, 2023

Last Update Posted:

Sep 13, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Study Results

No Results Posted as of Sep 13, 2023