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

NCT05042388 | Completed Results DMC

• 2 other identifiers: R15DA0501021R15DA050102-01A1
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Opioid-use Disorder

Keywords

Addiction; Relapse Prevention; Opioid; Mindfulness

Outcome Measures

Primary Outcomes (10)

• Adherence to Medication Assisted Treatment (MAT)

  Whether participant received MAT during post-residential-treatment discharge follow-up phase

  Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).

• Adherence to Medication Assisted Treatment (MAT)

  Whether participant received MAT during post-residential-treatment discharge follow-up phase

  Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).

• Adherence to Medication Assisted Treatment (MAT)

  Whether participant received MAT during post-residential-treatment discharge follow-up phase

  Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).

• Opioid Drug Use

  Participant relapse to opioids - Determined by synthesis of data recorded from participant EHR, participant self-report, and/or correspondence with participant healthcare provider. Any discrepancies between data sources (i.e., participant report no use, provider and/or EHR designated Yes to use) were coded as opioid use.

  Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).

• Opioid Drug Use

  Participant relapse to opioids - Determined by synthesis of data recorded from participant EHR, participant self-report, and/or correspondence with participant healthcare provider. Any discrepancies between data sources (i.e., participant report no use, provider and/or EHR designated Yes to use) were coded as opioid use.

  Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).

• Opioid Drug Use

  Participant relapse to opioids - Determined by synthesis of data recorded from participant EHR, participant self-report, and/or correspondence with participant healthcare provider. Any discrepancies between data sources (i.e., participant report no use, provider and/or EHR designated Yes to use) were coded as opioid use.

  Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).

• Opioid Craving

  Opioid Craving Scale (OCS; McHugh et al., 2014), 3-item self-report questionnaire assessing opioid craving (higher scores = greater opioid craving; Range: 0-30). This scale uses a visual analogue scale ranging from 0 to 10 to assess opioid craving via response to three questions querying current craving (0 = not at all, 10 = extremely), past week desire for opioids when reminded of opiates (0 = no desire, 10 = extremely strong desire), and imagined likelihood of opioid use if in the environment in which opioids were previously used (0 = not at all, 10 = certainty of use). Total score reported.

  Assessed immediately prior to discharge from residential addiction treatment facility.

• Opioid Craving

  Opioid Craving Scale (OCS; McHugh et al., 2014), 3-item self-report questionnaire assessing opioid craving (higher scores = greater opioid craving; Range: 0-30). This scale uses a visual analogue scale ranging from 0 to 10 to assess opioid craving via response to three questions querying current craving (0 = not at all, 10 = extremely), past week desire for opioids when reminded of opiates (0 = no desire, 10 = extremely strong desire), and imagined likelihood of opioid use if in the environment in which opioids were previously used (0 = not at all, 10 = certainty of use). Total score reported.

  Assessed 1-month following discharge from residential addiction treatment facility (approximately 30 days post discharge)

• Opioid Craving

  Opioid Craving Scale (OCS; McHugh et al., 2014), 3-item self-report questionnaire assessing opioid craving (higher scores = greater opioid craving; Range: 0-30). This scale uses a visual analogue scale ranging from 0 to 10 to assess opioid craving via response to three questions querying current craving (0 = not at all, 10 = extremely), past week desire for opioids when reminded of opiates (0 = no desire, 10 = extremely strong desire), and imagined likelihood of opioid use if in the environment in which opioids were previously used (0 = not at all, 10 = certainty of use). Total score reported.

  Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post discharge)

• Opioid Craving

  Opioid Craving Scale (OCS; McHugh et al., 2014), 3-item self-report questionnaire assessing opioid craving (higher scores = greater opioid craving; Range: 0-30). This scale uses a visual analogue scale ranging from 0 to 10 to assess opioid craving via response to three questions querying current craving (0 = not at all, 10 = extremely), past week desire for opioids when reminded of opiates (0 = no desire, 10 = extremely strong desire), and imagined likelihood of opioid use if in the environment in which opioids were previously used (0 = not at all, 10 = certainty of use). Total score reported.

  Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post discharge)

Secondary Outcomes (32)

• Dispositional Mindfulness

  Assessed immediately prior to discharge from residential addiction treatment facility.

• Dispositional Mindfulness

  Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).

• Dispositional Mindfulness

  Assessed 2 month following discharge from residential addiction treatment facility (approximately 60 days post-discharge).

• Dispositional Mindfulness

  Assessed 3 month following discharge from residential addiction treatment facility (approximately 90 days post-discharge).

• Global Mental Health

  Assessed immediately prior to discharge from residential addiction treatment facility.

Other Outcomes (2)

• MBRP Adherence and Competence Scale (MBRP-AC): Adherence Subscale

  MBRP audiorecorded sessions occurred throughout the duration of the study up to 3 years; randomly selected recordings were coded for Adherence. These recordings were evaluated for adherence after the study concluded and MBRP was no longer being delivered

• MBRP Adherence and Competence (MBRP-AC): Competence Subscale

  MBRP audiorecorded sessions occurred throughout the duration of the study up to 3 years; randomly selected recordings were coded for Adherence. These recordings were evaluated for competence after the study concluded and MBRP was no longer being delivered

Study Arms (2)

Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)

EXPERIMENTAL

Group intervention comprised of didactics and trainings in cognitive behavioral therapy relapse prevention skills and mindfulness meditation.

Behavioral: Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)

Treatment-As-Usual (TAU)

ACTIVE COMPARATOR

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.

Behavioral: Treatment-As-Usual

Interventions

Treatment-As-Usual BEHAVIORAL

Standard treatment programming procedures for all individuals residing within the residential treatment program. Includes: supportive group therapy; Narcotics Anonymous/12-Step Programming; music, art, and animal therapy; psycho-education on general issues related to mental health and SUDs; and medication counseling.

Treatment-As-Usual (TAU)

Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA) BEHAVIORAL

Integrates evidenced-based practices to decrease the probability and severity of relapse for those in addiction recovery. MBRP incorporates components from CBT relapse prevention and includes training in meditation practices as a means to foster increased awareness of emotional and cognitive experiences. MBRP also includes training in brief informal meditations aimed at increasing awareness and adaptive response to drug cues and negative affect.

Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• West Chester University of Pennsylvania: lead

Study Sites (1)

Gaudenzia, Inc. (West Chester House)

West Chester, Pennsylvania, 19382, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Results Point of Contact

• Title: Michael Gawrysiak, Ph.D., Principal Investigator
• Organization: West Chester University of Pennsylvania

MGawrysiak@wcupa.edu

610-436-3999

Study Officials

• Michael J Gawrysiak, PhD

  West Chester University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor collecting information from the participants during each post-discharge follow-up phase will be blind to which treatment condition the participant was assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Model Details: Participants will be randomly assigned to 1 of 2 conditions: MBRP+TAU or TAU.

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 13, 2021
• Study Start: August 1, 2021
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: March 31, 2026
• Results First Posted: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: When deemed appropriate by the study PI, data will be available after all primary research questions, statistical analyses, and publications have been completed.
• Access Criteria: Submission of a formal request to the study PI indicating what specific information is requested and what the intentions are for use of this data.

Locations

US (1)