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Recruiting NCT06033599

Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement

Phase III Interventional Polysubstance Abuse Opioid Use Tobacco Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MORE and MI and NRT, MORE and No MI and NRT, Support Group and MI and NRT, Support Group and No MI and NRT.
Who it may be relevant to
Registry conditions: Polysubstance Abuse, Opioid Use, Tobacco Use. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other MORE and MI and NRT
    Eight group Mindfulness Oriented Recovery Enhancement sessions and one motivational interviewing session and nicotine replacement therapy.
  • Other MORE and No MI and NRT
    Eight group Mindfulness Oriented Recovery Enhancement sessions and nicotine replacement therapy.
  • Other Support Group and MI and NRT
    Eight group support group sessions and one motivational interviewing session and nicotine replacement therapy.
  • Other Support Group and No MI and NRT
    Eight group support group sessions and and nicotine replacement therapy.

Primary outcome measures

  • Days of Drug Use [Time frame: Baseline through 52 weeks.]
  • Days of Tobacco Use [Time frame: Baseline through 52 weeks.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Rutgers Robert Wood Johnson Medical School — New Brunswick
  • University of Utah — Salt Lake City

Identifiers

NCT: NCT06033599 · Pro2022001551 · R01DA057631

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗