Clinical trial NCT05363371: Minds and Mentors Program- R33
Official title: A Mindfulness and Peer Mentoring Program to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R33 Phase)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Substance Use Disorders
Medication Assisted Treatment
Keywords: Opioid Use Disorder
Mindfulness based therapy
Cravings
Relapse prevention
Treatment retention
Depression
Stress
Anxiety
Cortisol
Peer Mentors
Lead sponsor: University of Alabama, Tuscaloosa
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: Tuscaloosa Veterans Affairs Medical Center
name: Pathway Healthcare, LLC
First posted: 2022-05-05
Enrollment: 240
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 have demonstrated efficacy of mindfulness-based interventions as adjunctive treatment for substance use disorders (SUD) while reducing substance use and cravings. In addition, non-randomized pilot studies suggest that mindfulness-based interventions may be effective in reducing symptoms of depression and anxiety in individuals undergoing MOUD.

The goal of the proposed study is to determine the effectiveness of a mindfulness-based intervention that also utilizes peer mentors in addition to professional substance abuse therapists (the Minds and Mentors program \[MiMP\]) in improving adherence to MOUD and reducing relapse rates in a sample of individuals with OUD who are also on MOUD versus a twelve-step facilitation (TSF) program. The MiMP is a twelve-week intervention that uses group therapy and meets once a week for about two hours. The primary outcome measure will is adherence to medications for OUD. The secondary outcome measures will include the demographic covariates, depression, anxiety, stress, quality of life, and cravings. Finally, exploratory outcome measures will include cortisol levels and rates of reactivity to drug cues. This study will randomize participants in either intervention or control group in blocks of five. Data collection will occur at baseline, 8 weeks, 12 weeks (end of treatment) and at 12- week and 24- week follow-up.

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.

Primary outcomes:
measure: Adherence Rate
timeFrame: 9 months
Secondary outcomes:
measure: Relapse
timeFrame: 9 months
measure: Cravings
timeFrame: 9 months
measure: Depression
timeFrame: 9 months
measure: Stress
timeFrame: 9 months
measure: Anxiety
timeFrame: 9 months
measure: Quality of Life
timeFrame: 9 months
Other outcomes:
measure: Cortisol Reactivity
timeFrame: 9 months
Locations:
city: Birmingham
country: United States
facility: Birmingham Veteran Affairs Medical Center
state: Alabama
city: Birmingham
country: United States
facility: Pathway Healthcare, LLC
state: Alabama
city: Tuscaloosa
country: United States
facility: Tuscaloosa Veteran Affairs Medical Center
state: Alabama
city: Tuscaloosa
country: United States
facility: University of Alabama
state: Alabama
Study officials:
References: