Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06033599
• Other study ID #: Pro2022001551
• Secondary ID: R01DA057631
• Status: Recruiting
• Phase: Phase 3
• Start date: September 5, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: October 2023
• Source: Rutgers, The State University of New Jersey
• Contact: Nina Cooperman, PsyD
• Phone: 732-235-8569
• Email: cooperna[@]rwjms.rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Use
• Polysubstance Abuse
• Tobacco Use

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	University of Utah	Salt Lake City	Utah

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days of Drug Use	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.
Primary	Days of Tobacco Use	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.