NCT06033599

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P50-P75 for phase_3

Timeline
26mo left

Started Sep 2023

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Sep 2023Jun 2028

First Submitted

Initial submission to the registry

September 5, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

September 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

3.8 years

First QC Date

September 5, 2023

Last Update Submit

April 27, 2026

Conditions

Polysubstance AbuseOpioid UseTobacco Use

Outcome Measures

Primary Outcomes (2)

  • 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.

Study Arms (4)

MORE and MI

EXPERIMENTAL
Other: MORE and MI and NRT

MORE and No MI

EXPERIMENTAL
Other: MORE and No MI and NRT

Support Group and MI

ACTIVE COMPARATOR
Other: Support Group and MI and NRT

Support Group and No MI

ACTIVE COMPARATOR
Other: Support Group and No MI and NRT

Interventions

MORE and MI and NRTOTHER

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

MORE and MI
MORE and No MI and NRTOTHER

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

MORE and No MI
Support Group and MI and NRTOTHER

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

Support Group and MI
Support Group and No MI and NRTOTHER

Eight group support group sessions and and nicotine replacement therapy.

Support Group and No MI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English-speaking
  • Age ≥18
  • Currently on methadone; and 4) currently smoke cigarettes.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84108, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use

Interventions

Nicotine Replacement TherapySelf-Help Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsOrganizationsHealth Care Economics and Organizations

Study Officials

  • Nina Cooperman, PsyD

    Rutgers Robert Wood Johnson Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nina Cooperman, PsyD

CONTACT

732-235-8569cooperna@rwjms.rutgers.edu

Eric Garland, PhD

CONTACT

801-581-3826eric.garland@socwk.utah.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 13, 2023

Study Start

September 5, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2028

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

All participant individual data will be available after de-identification.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be available three months through five years after study publication
Access Criteria
Researchers who provide a methodologically sound proposal.

Locations

US(2)