Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement

Study Overview
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Brief Summary
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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.

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

Conditions
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Polysubstance Abuse, Opioid Use, Tobacco Use

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MORE and MI<br> | Other: MORE and MI and NRT<br>* Eight group Mindfulness Oriented Recovery Enhancement sessions and one motivational interviewing session and nicotine replacement therapy.<br>|
| Experimental: MORE and No MI<br> | Other: MORE and No MI and NRT<br>* Eight group Mindfulness Oriented Recovery Enhancement sessions and nicotine replacement therapy.<br>|
| Active Comparator: Support Group and MI<br> | Other: Support Group and MI and NRT<br>* Eight group support group sessions and one motivational interviewing session and nicotine replacement therapy.<br>|
| Active Comparator: Support Group and No MI<br> | Other: Support Group and No MI and NRT<br>* Eight group support group sessions and and nicotine replacement therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. |