Mindfulness-Based Relapse Prevention to Improve Medication Assisted Treatment Adherence and Drug-use Outcomes for Opioid Use Disorder

Not Applicable

Completed

• Conditions: Opioid-use Disorder
• Interventions: Behavioral: Treatment-As-Usual; Behavioral: Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)

• Registration Number: NCT05042388
• Lead Sponsor: West Chester University of Pennsylvania

Brief Summary

This proposal aims to determine whether an adjunctive Mindfulness-Based Relapse Prevention (MBRP) treatment program improves Medication Assisted Treatment (MAT) adherence and reduces drug-use among opioid use disorder (OUD) patients. The broad long-term objectives of this project are to investigate how integrative pharmacological and behavioral treatments improve OUD treatment outcomes. Participants for this study will include 200 patients diagnosed with opioid use disorder (OUD), that are enrolled in a 60-day residential addiction treatment program and prescribed MAT for OUD. Participants will be randomly assigned to a MBRP behavioral treatment condition or a non-MBRP treatment-as-usual (TAU) control condition as part of their treatment within the residential addiction treatment program. All participants will be monitored for three-months following their discharge from the program to test the hypotheses that MBRP participants, relative to TAU participants, will (1) demonstrate greater MAT adherence following discharge, and (2) evidence reduced drug-use following discharge.

Detailed Description

Medically detoxified OUD patients enrolling into a 60-day residential program will be randomized to either MAT Treatment-As-Usual (TAU; n=100) or TAU+MBRP (MBRP; n=100) as part of their residential treatment and followed for 3-months post-discharge to assess MAT adherence and drug-use. All participants (n=200) will participate in residential TAU (i.e., MAT, supportive group therapy), will be scheduled monthly MAT appointments per discharge treatment procedures, and will complete assessments at baseline, post- treatment, and 1-, 2-, and 3-month follow-ups. Study Aims include:

AIM 1 (PRIMARY): Compare impact of TAU versus TAU+MBRP on medication adherence and drug-use outcomes. Hypotheses: Relative to TAU, TAU+MBRP participants will demonstrate a) greater MAT adherence measured at follow-up timepoints, and b) reduced drug-use (i.e., self-report, urine drug-screens \[UDS\]) measured at discharge and follow-up timepoints. AIM 2: Determine whether the beneficial effects of TAU+MBRP on outcome are mediated by improvements in opioid craving and dispositional mindfulness. Hypotheses: TAU+MBRP participants will report greater improvements in distress tolerance and mindfulness, relative to TAU, which will mediate treatment outcomes (i.e., MAT adherence, reduced drug use and positive-UDS). EXPLORATORY AIM 3: Determine effects of baseline factors on treatment outcomes. Hypotheses: More severe trauma exposure (i.e., increased number of traumas) and greater posttraumatic stress symptom severity will result in poorer treatment adherence (i.e., reduced MAT follow-up appointments) and worse drug-use outcomes (i.e., increased self-reported drug use, positive-urine drug-screens) throughout each the follow-up assessments among TAU participants but not among MBRP participants.

Study Design Overview: In an randomized controlled trial design, patients enrolling into a residential addiction treatment center will be randomized to TAU (i.e., MAT, supportive group therapy) or TAU+MBRP with comparisons being made between MBRP (n=100) and treatment-as-usual (TAU; n=100) on assessment measures collected at baseline, prior to residential discharge, and at 1, 2, and 3-month follow-up time points. To address AIM 1 (TAU+MBRP, Adherence and Drug-Use): participants will be randomly assigned to receive TAU or MBRP+TAU, during their residence within an inpatient treatment setting and will complete assessments at enrollment, prior to discharge, and at 1, 2, and 3-months follow-up to assess MAT adherence and drug-use. Comparisons, on assessment measures collected at follow-up, will be made between treatment conditions to determine if MBRP+TAU results in greater number MAT adherence, fewer positive UDS, reduced drug-craving, and increased mindfulness. AIM 2 (MBRP Mechanisms of Change): Will determine whether the beneficial effects of MBRP on treatment outcome (i.e., MAT adherence, drug-use) are mediated by increases in mindfulness and distress tolerance. AIM 3 (Predictors of MAT Adherence): will examine the extent to which prior trauma-exposure and PTSD symptom severity moderates MAT adherence and drug-use outcomes, among TAU participants (but not MBRP participants), following discharge from residential treatment.

Study Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2021-08-27
• Study First Submitted QC: 2021-09-03
• Study First Posted: 2021-09-13
• Primary Completion: 2024-08-20
• Study Completion: 2024-08-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

1. An informed consent document voluntarily signed and dated by the subject.
2. Subject must understand and be able to read and write in English.
3. Enrollment in residential treatment at study site.
4. Physically healthy males and females, aged 18 or older, who meet criteria for opioid use disorder (based on Diagnostic and Statistical Manual 5th Edition criteria) as their primary diagnosis, who are enrolled in residential treatment at the collaborating study site.
5. Subject must be willing to be randomized to treatment condition.
6. Subjects who are willing and able to comply with scheduled visits and other study procedures.

Exclusion Criteria

1. Meets current or lifetime DSM-V criteria for schizophrenia or any psychotic disorder or organic mental disorder, including dementia-related psychosis as determined by the semi-structured interview.
2. Presence of any other psychiatric disorder that in the opinion of the PI will interfere with completion of the study or place the patient at heightened risk through participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment-As-Usual (TAU)	Treatment-As-Usual	Standard procedure for residential treatment program. Includes: supportive group therapy; Narcotics Anonymous/12-Step Programming; music, art, and animal therapy; psycho-education on issues related to mental health and substance use disorders; and medication counseling. No aspect of the treatment-as-usual services provided entails mindfulness training or components of mindfulness training.
Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)	Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)	Group intervention comprised of didactics and trainings in cognitive behavioral therapy relapse prevention skills and mindfulness meditation.

Primary Outcome Measures

Name	Time	Method
Adherence to Medication Assisted Treatment (MAT)	Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).	Whether participant receives MAT during post-residential-treatment discharge follow-up phase
Drug Use (self-report)	Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).	Assessed via participant completion of research-assistant administered time-line followback interview (follow-up phone call)
Opioid Craving	Assessed 3 month following discharge from residential addiction treatment facility (approximately 90 days post-discharge).	Opioid craving will be assessed using the Opioid Craving Scale (McHugh et al., 2014). Scores for this scale range from 0 to 30, with higher scores reflecting greater craving for opioids (i.e., worse outcome).
Drug Use (Urine Drug Screens)	Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge)	Assessed via medical record review of urine drug-screens (when possible)

Secondary Outcome Measures

Name	Time	Method
Dispositional Mindfulness	Assessed at baseline, pre-discharge (approximately 50 days following residential admission), and 1-, 2-, and 3-months post-residential-treatment discharge.	Cognitive and Affective Mindfulness Scale (Feldman et al., 2007). Scores for this scale range from 10 to 40 with higher scores reflecting greater dispositional mindfulness (i.e., favorable outcomes). Scores for this measure will determine the changes across time (i.e., pre-post treatment and follow-up phases of study).
MBRP Treatment Adherence	Assessed for MBRP participants during residential treatment (~5 weeks)	Number of MBRP sessions attended and self-report measures recording homework completion (e.g., frequency/duration of meditation practices).
Post-Discharge Treatment Utilization	Assessed 1-, 2-, and 3-months post-residential-treatment discharge.	Assessment of behavioral treatment services used during post-discharge follow-up assessment time-points.
Patient Reported Outcomes - Mental Health	Assessed at baseline, pre-discharge (approximately 50 days following residential admission), and 1-, 2-, and 3-months post-residential-treatment discharge.	Assessed with the Patient-Reported Outcomes Measurement Information. System (Cella et al., 2010). Scores for this scale range from 4 to 20 with higher scores reflecting greater overall mental health (i.e., favorable outcomes). Scores for this measure will determine the changes across time (i.e., pre-post treatment and follow-up phases of study).
Reward Probability	Assessed at baseline, pre-discharge (approximately 50 days following residential admission), and 1-, 2-, and 3-months post-residential-treatment discharge.	Reward Probability Inventory (Carvalho et al., 2011). Scores for this scale range from 20 to 80 with higher scores reflecting greater perceived access to and engagement in rewarding and pleasurable activities (i.e., favorable outcomes). Scores for this measure will determine the changes across time (i.e., pre-post treatment and follow-up phases of study).

Trial Locations

Locations (1)

Gaudenzia, Inc. (West Chester House); 🇺🇸 West Chester, Pennsylvania, United States