N/A N=105 Randomized Single-blind Treatment

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

Opioid-use Disorder

Bottom Line

View on ClinicalTrials.gov: NCT05042388 ↗

Enrolled (actual)

105

Serious AEs

3.8%

Results posted

Mar 2026

Primary outcome: Primary: Adherence to Medication Assisted Treatment (MAT) — 32; 17 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA) (Behavioral); Treatment-As-Usual (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: West Chester University of Pennsylvania
Primary completion: Aug 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Adherence to Medication Assisted Treatment (MAT)	20; 12	—
PRIMARY Adherence to Medication Assisted Treatment (MAT)	20; 12	—
PRIMARY Adherence to Medication Assisted Treatment (MAT)	20; 12	—
PRIMARY Opioid Drug Use	3; 2	—
PRIMARY Opioid Drug Use	3; 2	—
PRIMARY Opioid Drug Use	3; 2	—
PRIMARY Opioid Craving	3.33; 6.89	—
PRIMARY Opioid Craving	3.33; 6.89	—
PRIMARY Opioid Craving	3.33; 6.89	—
PRIMARY Opioid Craving	3.33; 6.89	—
SECONDARY Dispositional Mindfulness	32.00; 30.22	—
SECONDARY Dispositional Mindfulness	32.00; 30.22	—
SECONDARY Dispositional Mindfulness	32.00; 30.22	—
SECONDARY Dispositional Mindfulness	32.00; 30.22	—
SECONDARY Global Mental Health	13.00; 12.39	—
SECONDARY Global Mental Health	13.00; 12.39	—
SECONDARY Global Mental Health	13.00; 12.39	—
SECONDARY Global Mental Health	13.00; 12.39	—
SECONDARY Reward Probability Inventory: Reward Probability	34.95; 34.89	—
SECONDARY Reward Probability Inventory: Reward Probability	34.95; 34.89	—
SECONDARY Reward Probability Inventory: Reward Probability	34.95; 34.89	—
SECONDARY Reward Probability Inventory: Reward Probability	34.95; 34.89	—
SECONDARY Reward Probability Inventory: Environmental Suppression	25.11; 23.67	—
SECONDARY Reward Probability Inventory: Environmental Suppression	25.11; 23.67	—
SECONDARY Reward Probability Inventory: Environmental Suppression	25.11; 23.67	—
SECONDARY Reward Probability Inventory: Environmental Suppression	25.11; 23.67	—
SECONDARY Abstinence Self-Efficacy	.87; .88	—
SECONDARY Abstinence Self-Efficacy	.87; .88	—
SECONDARY Abstinence Self-Efficacy	.87; .88	—
SECONDARY Abstinence Self-Efficacy	.87; .88	—
SECONDARY Posttraumatic Stress Severity	12.62; 22.60	—
SECONDARY Posttraumatic Stress Severity	12.62; 22.60	—
SECONDARY Posttraumatic Stress Severity	12.62; 22.60	—
SECONDARY Posttraumatic Stress Severity	12.62; 22.60	—
SECONDARY Trauma Symptoms of Discrimination	43.34; 44.96	—
SECONDARY Treatment Engagement	2.28; 1.69	—
SECONDARY Treatment Engagement	2.28; 1.69	—
SECONDARY Treatment Engagement	2.28; 1.69	—
SECONDARY Mindfulness of Craving	28.65; 24.89	—
SECONDARY Mindfulness of Craving	28.65; 24.89	—
SECONDARY Mindfulness of Craving	28.65; 24.89	—
SECONDARY Mindfulness of Craving	28.65; 24.89	—

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. This study aims to include 200 patients diagnosed with with opioid use disorder (OUD), that are enrolled in a ~60-day residential addiction treatment program. Participant recruitment will prioritize participants that are 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.

Eligibility Criteria

Inclusion Criteria

An informed consent document voluntarily signed and dated by the subject.
Subject must understand and be able to read and write in English.
Enrollment in residential treatment at study site.
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.
Subject must be willing to be randomized to treatment condition.
Subjects who are willing and able to comply with scheduled visits and other study procedures.

Exclusion Criteria

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.
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05042388). 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.