Status:
RECRUITING
Minds and Mentors Program- R33
Lead Sponsor:
University of Alabama, Tuscaloosa
Collaborating Sponsors:
University of Alabama at Birmingham
Tuscaloosa Veterans Affairs Medical Center
Conditions:
Opioid Use Disorder
Substance Use Disorders
Eligibility:
All Genders
19+ years
Phase:
NA
Brief 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 medicatio...
Detailed Description
Although medications for opioid use disorders (MOUD) is safe and effective and is currently considered the gold standard for treating OUD, adherence to MOUD regimens remains a challenge. Early studies...
Eligibility Criteria
Inclusion
- 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
- Willing to commit to 12 group therapy sessions, baseline, and follow-up assessments for 24 weeks after the end of treatment (9- month total)
Exclusion
- Significant cognitive impairment
- 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
- Subject Exit criteria:
- 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
- Inability to return for therapy sessions for four consecutive weeks.
Key Trial Info
Start Date :
January 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2024
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05363371
Start Date
January 4 2022
End Date
August 31 2024
Last Update
May 29 2024
Active Locations (4)
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1
Birmingham Veteran Affairs Medical Center
Birmingham, Alabama, United States, 35233
2
Pathway Healthcare, LLC
Birmingham, Alabama, United States, 35235
3
Tuscaloosa Veteran Affairs Medical Center
Tuscaloosa, Alabama, United States, 35404
4
University of Alabama
Tuscaloosa, Alabama, United States, 35487