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MI + MORE + NRT for Substance Abuse

Phase 3
Recruiting
Led By Nina Cooperman, PsyD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Currently on methadone
Age ≥18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 52 weeks.
Awards & highlights

Study Summary

This trial tests strategies to help people quit drugs like opioids and tobacco, and evaluates if they work.

Who is the study for?
This trial is for English-speaking adults over 18 who smoke cigarettes and are currently on methadone. It's not suitable for those unable to attend sessions, pregnant or breastfeeding individuals, people with severe cognitive issues or psychosis, high suicidal risk, previous mindfulness training, or those already in smoking cessation programs.Check my eligibility
What is being tested?
The study tests the effectiveness of combining Motivational Interviewing (MI) and Mindfulness-Oriented Recovery Enhancement (MORE) with Nicotine Replacement Therapy (NRT) to reduce opioid, tobacco, and other drug use. Participants will be grouped into different combinations of support groups, MI, MORE, and NRT.See study design
What are the potential side effects?
While specific side effects aren't detailed here as it focuses on behavioral therapies combined with NRT which typically includes nicotine gum or patches that may cause mouth soreness or skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently taking methadone.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 52 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 52 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Days of Drug Use
Days of Tobacco Use

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: MORE and No MIExperimental Treatment1 Intervention
Group II: MORE and MIExperimental Treatment1 Intervention
Group III: Support Group and No MIActive Control1 Intervention
Group IV: Support Group and MIActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
63,812 Total Patients Enrolled
University of UtahOTHER
1,100 Previous Clinical Trials
1,778,481 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,311 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do the benefits of MORE and MI outweigh any potential hazards to patients?

"Based on the Phase 3 status of this trial, our team at Power assesses MORE and MI to be a 3 in terms of safety. This evaluation is based off pre-existing studies demonstrating their efficacy as well as various rounds of data confirming security."

Answered by AI

How many participants are being welcomed into this experiment?

"Affirmative. Per information on clinicaltrials.gov, this experiment is still recruiting patients - the trial being first posted on September 5th 2023 and recently updated on October 7th 2023. 420 individuals need to be sourced from 2 distinct sites for successful completion of the study."

Answered by AI

Does this research endeavor require additional participants?

"Affirmative. According to clinicaltrials.gov, the trial posted on September 5th 2023 is now in its active recruitment phase. 420 people are needed for this study and can be found at two separate medical sites."

Answered by AI

Who else is applying?

What site did they apply to?
Rutgers Robert Wood Johnson Medical School
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement
Nina A. Cooperman, Psy. D. 2023. "Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06033599.
~280 spots leftby Jun 2026
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