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Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06033599
Enrollment
420
Registered
2023-09-13
Start date
2023-09-05
Completion date
2028-08-01
Last updated
2026-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use, Polysubstance Abuse, Tobacco Use

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.

Interventions

OTHERMORE and MI and NRT

Eight group Mindfulness Oriented Recovery Enhancement sessions and one motivational interviewing session and nicotine replacement therapy.

OTHERMORE and No MI and NRT

Eight group Mindfulness Oriented Recovery Enhancement sessions and nicotine replacement therapy.

OTHERSupport Group and MI and NRT

Eight group support group sessions and one motivational interviewing session and nicotine replacement therapy.

OTHERSupport Group and No MI and NRT

Eight group support group sessions and and nicotine replacement therapy.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Days of Drug UseBaseline 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 UseBaseline 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.

Countries

United States

Contacts

CONTACTNina Cooperman, PsyD
cooperna@rwjms.rutgers.edu732-235-8569
CONTACTEric Garland, PhD
eric.garland@socwk.utah.edu801-581-3826
PRINCIPAL_INVESTIGATORNina Cooperman, PsyD

Rutgers Robert Wood Johnson Medical School

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 18, 2026