Polysubstance AbusePhase 3NCT06033599
Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement
A Phase 3 study testing MORE and MI and NRT, MORE and No MI and NRT and Support Group and MI and NRT in people with Polysubstance Abuse and Opioid Use, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polysubstance Abuse, Opioid Use, Tobacco Use
- What is being tested?
- MORE and MI and NRT, MORE and No MI and NRT and Support Group and MI and NRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Sep 2023to Aug 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking
- Age ≥18
- Currently on methadone; and 4) currently smoke cigarettes.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Nina Cooperman, 7322358569, cooperna@rwjms.rutgers.edu
- Recruiting
University of Utah
Salt Lake City, Utah, 84108
Eric Garland, PhD, (801) 581-3826, Eric.Garland@socwk.utah.edu
About this study
Official title: Motivational Interviewing (MI) and Mindfulness-Oriented Recovery Enhancement (MORE) for Tobacco Dependence and Other Drug Use in Methadone Treatment
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.
- Conditions
- Polysubstance Abuse, Opioid Use, Tobacco Use
- Being tested
- MORE and MI and NRT, MORE and No MI and NRT, Support Group and MI and NRT, Support Group and No MI and NRT
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MORE and MI and NRTOther
Eight group Mindfulness Oriented Recovery Enhancement sessions and one motivational interviewing session and nicotine replacement therapy.
MORE and No MI and NRTOther
Eight group Mindfulness Oriented Recovery Enhancement sessions and nicotine replacement therapy.
Support Group and MI and NRTOther
Eight group support group sessions and one motivational interviewing session and nicotine replacement therapy.
Support Group and No MI and NRTOther
Eight group support group sessions and and nicotine replacement therapy.
| Study group | Role | What they receive |
|---|---|---|
| MORE and MI | Experimental | Not described Receives: Other: MORE and MI and NRT |
| MORE and No MI | Experimental | Not described Receives: Other: MORE and No MI and NRT |
| Support Group and MI | Active comparator | Not described Receives: Other: Support Group and MI and NRT |
| Support Group and No MI | Active comparator | Not described Receives: Other: Support Group and No MI and NRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline through 52 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start5 Sep 2023
- Primary completionJun 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polysubstance AbuseStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Nina A. Cooperman, Psy. D., Rutgers, The State University of New Jersey
- Investigators
- Nina Cooperman, PsyD, Principal investigator, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033599
- Sponsor's protocol ID
- Pro2022001551
- Other IDs
- R01DA057631
- Status last verified
- Jul 2026
- First submitted
- 5 Sep 2023
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All participant individual data will be available after de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing (MI) and Mindfulness-Oriented Recovery Enhancement (MORE) for Tobacco Dependence and Other Drug Use in Methadone Treatment
- ClinicalTrials.gov ID
- NCT06033599
- Acronym / sponsor ID
- Pro2022001551
- Conditions
- Polysubstance Abuse, Opioid Use, Tobacco Use
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- University of Utah, National Institute on Drug Abuse (NIDA)
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking
- Age ≥18
- Currently on methadone; and 4) currently smoke cigarettes.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MORE and MI and NRTEight group Mindfulness Oriented Recovery Enhancement sessions and one motivational interviewing session and nicotine replacement therapy. | Other | MORE and MI |
| MORE and No MI and NRTEight group Mindfulness Oriented Recovery Enhancement sessions and nicotine replacement therapy. | Other | MORE and No MI |
| Support Group and MI and NRTEight group support group sessions and one motivational interviewing session and nicotine replacement therapy. | Other | Support Group and MI |
| Support Group and No MI and NRTEight group support group sessions and and nicotine replacement therapy. | Other | Support Group and No MI |
Primary outcome
Days of Drug Use
Time frame: Baseline 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 Use
Time frame: Baseline 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Yes. All participant individual data will be available after de-identification.
Related trials for Polysubstance Abuse
Active, not recruiting
Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations
Polysubstance Abuse, Posttraumatic Stress Disorder
RecruitingObservational study
CEDRN: Opioid Registry
Opioid Use Disorder, Opioid Abuse or Dependence
Active, not recruitingPhase 1
Cannabis and Polysubstance Use: Response Inhibition and Stress Exposure
Healthy
RecruitingPhase 2
Opioid/Benzodiazepine Polydrug Abuse: Aim 3
Opioid Abuse, Benzodiazepine Abuse
RecruitingObservational study
Opioid/Benzodiazepine Polydrug Abuse
Polysubstance Abuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nina Cooperman, PsyD principal investigator
Rutgers Robert Wood Johnson Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MORE and MI and NRT, MORE and No MI and NRT and Support Group and MI and NRT in people with Polysubstance Abuse and Opioid Use, run by Rutgers, The State University of New Jersey at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nina Cooperman, PsyD (732-235-8569, cooperna@rwjms.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days of Drug Use (time frame: Baseline through 52 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.