N/A
Completed N=21
Minds and Mentors Program (MiMP)- R61
Opioid Use Disorder · Medication Assisted Treatment · Substance Use Disorder
Source: ClinicalTrials.gov NCT04233671 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcomePrimary: Number of Days Adherence to Medication Assisted Treatment — 28; 23.25 days
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Days Adherence to Medication Assisted Treatment |
28; 23.25 | — |
| SECONDARY Feasibility of Mindfulness Based Relapse Prevention as Measured by Retention Rate |
8; 4 | — |
| SECONDARY Acceptability and Adherence to Mindfulness Based Relapse Prevention as Measured by the Treatment Acceptability/Adherence (TAAS) Scale |
71; 78 | — |
| SECONDARY Satisfaction With the Intervention Program |
28.9; 30.8 | — |
| SECONDARY Acceptability of the Intervention Programs |
8; 4 | — |
| SECONDARY Relapse Rate (Number of Participants With Relapse) as Determined by Urine Drug Screen |
3; 2 | — |
| SECONDARY Relapse Rate (Number of Participants With Relapse) as Measured Via Self-report |
3; 2 | — |
| SECONDARY Opioid Cravings as Measured by the Opioid Craving Scale |
2.2; 3.9 | — |
| SECONDARY Social Support as Measured by the Community Assessment Inventory |
35.7; 27.0 | — |
| SECONDARY Depression as Measured by the Patient Health Questionnaire |
8.6; 12.7 | — |
| SECONDARY Stress as Measured by the Perceived Stress Scale |
20.6; 25.7 | — |
| SECONDARY Anxiety as Measured by the Generalized Anxiety Disorder Scale |
6.4; 12.7 | — |
| SECONDARY Feasibility of Mindfulness-based Relapse Prevention as Measured by Randomization Rate |
21 | — |
| SECONDARY Feasibility of Mindfulness-based Relapse Prevention as Measured by Enrollment Rate |
43 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04233671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.