NCT06033599 Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement
| NCT ID | NCT06033599 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Polysubstance Abuse |
| Study Type | INTERVENTIONAL |
| Enrollment | 420 participants |
| Start Date | 2023-09-05 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 420 participants in total. It began in 2023-09-05 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Nina Cooperman, PsyD
PRINCIPAL INVESTIGATOR
Rutgers Robert Wood Johnson Medical School
Frequently Asked Questions
Who can join the NCT06033599 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Polysubstance Abuse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06033599 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 420 participants.
Is NCT06033599 currently recruiting?
Yes, NCT06033599 is actively recruiting participants. Contact the research team at cooperna@rwjms.rutgers.edu for enrollment information.
Where is the NCT06033599 trial being conducted?
This trial is being conducted at New Brunswick, United States, Salt Lake City, United States.
Who is sponsoring the NCT06033599 clinical trial?
NCT06033599 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Nina Cooperman, PsyD at Rutgers Robert Wood Johnson Medical School. The trial plans to enroll 420 participants.