ClinConnect ClinConnect Logo
Search / Trial NCT05363371

Minds and Mentors Program- R33

Launched by UNIVERSITY OF ALABAMA, TUSCALOOSA · May 2, 2022

Trial Information

Current as of November 15, 2025

Recruiting

Keywords

Opioid Use Disorder Mindfulness Based Therapy Cravings Relapse Prevention Treatment Retention Depression Stress Anxiety Cortisol Peer Mentors

ClinConnect Summary

The Minds and Mentors Program- R33 is a research study that aims to find out how effective a new group treatment program is for individuals dealing with opioid use disorder. In this trial, participants will be divided into two groups: one group will receive the Minds and Mentors Program, while the other group will follow a traditional approach called Twelve Step Facilitation. Researchers want to see if the new program helps people stick to their medication treatment, reduces cravings and relapses, and improves overall mental well-being, including feelings of anxiety and depression.

To be eligible for this study, participants need to be at least 19 years old, currently diagnosed with opioid use disorder, and receiving medication-assisted treatment like methadone or buprenorphine. Participants should also be able to attend 12 group therapy sessions over nine months and have access to the internet. During the study, participants will be monitored for improvements in their condition and well-being. It’s important to note that individuals with severe mental health issues or those who are actively suicidal will not be able to participate. This trial offers a structured support system for those looking to manage their opioid use more effectively.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age 19 and older
  • 2. Opioid Use disorder diagnosis based on DSM-V criteria in the past 30 days
  • 3. Currently receiving MOUD (e.g. methadone, naloxone, naltrexone, and buprenorphine) from an established provider
  • 4. Are within maintenance phase of MOUD (not actively detoxing)
  • 5. 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
  • 6. Capable of reading and understanding English
  • 7. Able to provide written informed consent (i.e. no surrogate)
  • 8. Access to a smartphone or a computer with an internet connection
  • 9. 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 Criteria:
  • 1. Significant cognitive impairment
  • 2. Women who are pregnant (does not impact eligibility post study initiation)
  • 3. Actively suicidal or homicidal
  • 4. Active psychosis and/ or
  • 5. Unstable medical conditions that contraindicate proposed treatment
  • Subject Exit criteria:
  • 1. Increases in alcohol or drug use leading to the need for a more intensive level of care (i.e., medical detoxification, inpatient)
  • 2. Newly developed active suicidal or homicidal ideation
  • 3. 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
  • 4. Inability to return for therapy sessions for four consecutive weeks.

About University Of Alabama, Tuscaloosa

The University of Alabama, Tuscaloosa, is a leading academic institution dedicated to advancing research and innovation in various fields, including medicine and healthcare. As a clinical trial sponsor, the university leverages its extensive resources, expert faculty, and state-of-the-art facilities to conduct rigorous research that aims to enhance patient care and contribute to medical knowledge. The university fosters collaboration among interdisciplinary teams, ensuring a comprehensive approach to clinical research that prioritizes participant safety and ethical standards. Through its commitment to excellence, the University of Alabama, Tuscaloosa, plays a pivotal role in translating scientific discoveries into effective clinical practices.

Locations

Tuscaloosa, Alabama, United States

Birmingham, Alabama, United States

Birmingham, Alabama, United States

Tuscaloosa, Alabama, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials