Last updated: June 29, 2023
Sponsor: University of Alabama, Tuscaloosa
Overall Status: Completed
Phase
N/A
Condition
Stimulant Use Disorder
Opioid Use Disorder
Addictions
Treatment
Mindfulness based relapse prevention and peer mentoring
Clinical Study ID
NCT04233671
1R61AT010802-01
Ages > 19 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- At least 19 years old.
- Opioid Use disorder diagnosis based on Diagnostic and Statistical Manual of MentalDisorders, 5th Edition (DSM-V) criteria in the past 30 days
- Currently receiving MAT for OUD (e.g. methadone, naloxone, naltrexone, andbuprenorphine) from an established provider
- Are within maintenance phase of MAT (not actively detoxing)
- May meet criteria for a mood, anxiety, or other psychiatric disorder based on theDSM-V criteria. Participants on maintenance medications for a mood or anxiety disordermust 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)
- Willing to commit to 8 group therapy sessions, baseline, and follow-up assessments for 12-months after the end of treatment (14- month total)
Exclusion
Exclusion Criteria:
- Significant cognitive impairment
- Women who are pregnant
- Actively suicidal or homicidal
- Active psychosis and/ or
- Unstable medical conditions that contraindicate proposed treatment Subject exit criteria:
- Increases in alcohol or drug use leading to the need for a more intensive level ofcare (i.e., medical detoxification, inpatient)
- Newly developed active suicidal or homicidal ideation
- Inability to manage psychiatric symptoms within the inclusion/exclusion criteria ofthe study (i.e., need for the initiation of maintenance psychotropic medications;development of psychosis). If it is determined, based on clinical criteria, that aparticipant needs to be started on maintenance medications for anxiety, mood orpsychotic symptoms during the study, they will be discontinued from the treatmenttrial
- Inability to return for therapy sessions due to incarceration or hospitalizationlasting longer than four weeks.
Study Design
Total Participants: 21
Treatment Group(s): 1
Primary Treatment: Mindfulness based relapse prevention and peer mentoring
Phase:
Study Start date:
January 28, 2020
Estimated Completion Date:
August 31, 2021
Study Description
Connect with a study center
Pathway Healthcare, LLC
Birmingham, Alabama 35235
United StatesSite Not Available
Fritz Clinic
Homewood, Alabama 35209
United StatesSite Not Available

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