Minds and Mentors Program- R33 (NCT05363371) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Minds and Mentors Program- R33
United States240 participantsStarted 2022-01-04
Plain-language summary
The proposed research effort will:
The purpose of this study is as follows:
1. Test the effectiveness of the Minds and Mentors Program in a group treatment trial in which individuals using medications for opioid use disorder (MOUD) will be randomized in blocks of five to receive either the Minds and Mentors Program (n=120) or Twelve Step Facilitation (n=120).
2. Determine whether the MiMP: a) improves adherence to MOUD b) reduces the rate of relapse and cravings c) decreases self-reported anxiety, stress, and depression and d) reduces cortisol levels and cortisol reactivity to drug cues.
3. Examine whether pre-intervention cortisol reactivity is predictive of relapse outcomes, and/ or reductions in cortisol reactivity over the course of intervention mediate relapse outcomes.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Age 19 and older
✓. Opioid Use disorder diagnosis based on DSM-V criteria in the past 30 days
✓. Currently receiving MOUD (e.g. methadone, naloxone, naltrexone, and buprenorphine) from an established provider
✓. Are within maintenance phase of MOUD (not actively detoxing)
✓. May meet criteria for a mood, anxiety, or other psychiatric disorder based on the DSM-V criteria. Participants on maintenance medications for a mood or anxiety disorder must be stabilized on medications for at least 2 weeks before therapy initiation
✓. Capable of reading and understanding English
✓. Able to provide written informed consent (i.e. no surrogate)
✓. Access to a smartphone or a computer with an internet connection
. Women who are pregnant (does not impact eligibility post study initiation)
✕. Actively suicidal or homicidal
✕. Active psychosis and/ or
✕. Unstable medical conditions that contraindicate proposed treatment
✕. Increases in alcohol or drug use leading to the need for a more intensive level of care (i.e., medical detoxification, inpatient)
✕. Newly developed active suicidal or homicidal ideation
✕. Inability to manage psychiatric symptoms within the inclusion/exclusion criteria of the study (i.e., need for the initiation of maintenance psychotropic medications; development of psychosis). If it is determined, based on clinical criteria, that a participant needs to be started on maintenance medications for anxiety, mood or psychotic symptoms during the study, they will be discontinued from the treatment trial