Clinical trial NCT04233671: Minds and Mentors Program (MiMP)- R61
Official title: A Mindfulness and Peer Mentoring Program to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders- R61
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Medication Assisted Treatment
Substance Use Disorders
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
First posted: 2020-01-18
Enrollment: 21
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional Study Model: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: The proposed research effort will:

The purpose of this study is as follows:

1. Test the feasibility and acceptability of a twelve- week mindfulness based relapse prevention protocol in combination with peer mentoring in individuals with opioid use disorder who are on medication assisted treatment.
2. Determine whether participation in a combination of mindfulness based relapse prevention and peer mentoring in comparison with an attentional control group: a) improves adherence to MAT b) decreases relapse and cravings c) improves psychosocial outcomes such as depression, anxiety, stress and social support

Detailed description: Although medication assisted therapy (MAT) for opioid use disorders (OUD) is safe and effective and is currently considered the gold standard for treating OUD, adherence to MAT regimens remains a challenge. 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 MAT for OUD and reducing relapse rates in a sample of individuals with OUD who are also on MAT 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 for eight weeks with a professional substance abuse therapist; after the completion of eight therapist led sessions, participants will attend four weeks of group therapy sessions conducted by a peer mentor. The peer mentor will also attend the initial eight sessions with the therapist to establish rapport with participants. The control group will attend twelve weeks of a standard twelve-step facilitation program. This study will utilize an individually randomized group treatment design with ten participants in both the intervention and control groups. Data collection will occur at baseline, end of treatment, and at 3, 6, and 12- month follow-up.

Eligibility criteria: Inclusion Criteria:

* At least 19 years old.
* Opioid Use disorder diagnosis based on Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria in the past 30 days
* Currently receiving MAT for OUD (e.g. methadone, naloxone, naltrexone, and buprenorphine) 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 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)
* 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 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 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 due to incarceration or hospitalization lasting longer than four weeks.

Primary outcomes:
measure: Number of Days Adherence to Medication Assisted Treatment
timeFrame: Last 4 weeks of the intervention period
Secondary outcomes:
measure: Feasibility of Mindfulness Based Relapse Prevention as Measured by Retention Rate
timeFrame: 12 months
measure: Acceptability and Adherence to Mindfulness Based Relapse Prevention as Measured by the Treatment Acceptability/Adherence (TAAS) Scale
timeFrame: 3 months - at the end of the 12 week intervention
measure: Satisfaction With the Intervention Program
timeFrame: 3 months - at the end of the 12 week intervention
measure: Acceptability of the Intervention Programs
timeFrame: 3 months
measure: Relapse Rate (Number of Participants With Relapse) as Determined by Urine Drug Screen
timeFrame: Last four weeks of the 12-week intervention
measure: Relapse Rate (Number of Participants With Relapse) as Measured Via Self-report
timeFrame: 3 months
measure: Opioid Cravings as Measured by the Opioid Craving Scale
timeFrame: 6 months
measure: Social Support as Measured by the Community Assessment Inventory
timeFrame: 6 months
measure: Depression as Measured by the Patient Health Questionnaire
timeFrame: 6 months
measure: Stress as Measured by the Perceived Stress Scale
timeFrame: 6 months
measure: Anxiety as Measured by the Generalized Anxiety Disorder Scale
timeFrame: 6 months
measure: Feasibility of Mindfulness-based Relapse Prevention as Measured by Randomization Rate
timeFrame: 12 months
measure: Feasibility of Mindfulness-based Relapse Prevention as Measured by Enrollment Rate
timeFrame: 12 months
Other outcomes:
measure: Baseline Cortisol Reactivity to Drug Cues
timeFrame: at baseline data collection
Locations:
city: Birmingham
country: United States
facility: Pathway Healthcare, LLC
state: Alabama
city: Homewood
country: United States
facility: Fritz Clinic
state: Alabama
Study officials:
affiliation: University of Alabama, Tuscaloosa
name: Mercy N Mumba, PhD
role: PRINCIPAL_INVESTIGATOR
References: