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NCT05363371 · ClinicalTrials.gov registry record · NA
Minds and Mentors Program- R33
A NA study of Opioid Use Disorder and Substance Use Disorders, sponsored by University of Alabama, Tuscaloo.
- Recruiting
- Registry status
- NA
- Development phase
- 240
- Enrollment target
- 4
- Study locations
NCT05363371: Recruiting NA study of Opioid Use Disorder and Substance Use Disorders, sponsored by University of Alabama, Tuscaloo.
NCT05363371 is a NA study of Opioid Use Disorder and Substance Use Disorders that is actively recruiting participants, run by University of Alabama, Tuscaloo. The registered enrollment target is 240 participants, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (95% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05363371, a NA study of Opioid Use Disorder and Substance Use Disorders, is actively recruiting participants, sponsored by University of Alabama, Tuscaloo.
- RECRUITING
- Registry status
- NA
- Development phase
- 240 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
Adherence rate operationalized as number of weeks a participant continually receives MOUD as prescribed by primary provider for the duration of the intervention and follow-up period
Conditions Studied
Interventions
- BEHAVIORAL Minds and Mentors
- BEHAVIORAL Twelve Step Intervention Group
Study Locations (4)
Alabama
- Birmingham Veteran Affairs Medical Center - Birmingham
- Pathway Healthcare, LLC - Birmingham
- Tuscaloosa Veteran Affairs Medical Center - Tuscaloosa
- University of Alabama - Tuscaloosa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2022-01-04 |
| Est. Completion | 2024-08-31 |
| Phase | NA |
What NCT05363371 shows while recruiting
NCT05363371 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Minds and Mentors is the first listed.
NCT05363371 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT05363371 about?
NCT05363371 is a clinical study titled "Minds and Mentors Program- R33". 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 a...
What is the current status of trial NCT05363371?
This trial is currently recruiting. It is a NA study. The enrollment target is 240 participants. The study started on 2022-01-04. Estimated completion is 2024-08-31.
What conditions does trial NCT05363371 study?
This clinical trial studies the following conditions: Opioid Use Disorder, Substance Use Disorders, Medication Assisted Treatment.
What interventions are being tested in trial NCT05363371?
The interventions under investigation include: Minds and Mentors (BEHAVIORAL), Twelve Step Intervention Group (BEHAVIORAL).
Who is sponsoring clinical trial NCT05363371?
This trial is sponsored by University of Alabama, Tuscaloo, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05363371 being conducted?
This trial has 4 study locations across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Opioid Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05363371's enrollment target sits among peer trials
240 75th of 257 higher than 180 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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