Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRutgers, The State University of New Jersey
About this trial
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
This trial does not accept healthy volunteersQualifiers
English-speaking
Age ≥18
Currently on methadone; and 4) currently smoke cigarettes.
Disqualifiers
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
Trial design
Design model
Factorial
Treatments tested in this trial
MORE and MI and NRT
Other interventionEight group Mindfulness Oriented Recovery Enhancement sessions and one motivational interviewing session and nicotine replacement therapy.
MORE and No MI and NRT
Other interventionEight group Mindfulness Oriented Recovery Enhancement sessions and nicotine replacement therapy.
Support Group and MI and NRT
Other interventionEight group support group sessions and one motivational interviewing session and nicotine replacement therapy.
Support Group and No MI and NRT
Other interventionEight group support group sessions and and nicotine replacement therapy.
Treatment groups
420 Participants
are divided into 4 treatment groupsGroup A: MORE and MIExperimental treatment 1 intervention
Group B: MORE and No MIExperimental treatment 1 intervention
Group C: Support Group and MIActive comparator 1 intervention
Group D: Support Group and No MIActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline through 52 weeks.2
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.
Time frame
Baseline through 52 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Rutgers, The State University of New Jersey
Lead sponsor
University of Utah
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov