COMPLETED

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

Conditions

Opioid-use Disorder Addiction Relapse Prevention Opioid Mindfulness

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mindful MAT Adherence: Mindfulness-Based Relapse Prevention (MBRP) to Improve Extended-release Naltrexone (XR-NTX) Adherence and Drug-use Outcomes for Opioid Use Disorder (OUD)

Quick Facts

Study Start:2021-08-01

Study Completion:2024-08-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05042388

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Principal Investigator

Michael J Gawrysiak, PhD

PRINCIPAL_INVESTIGATOR

West Chester University of Pennsylvania

Study Locations (Sites)

Gaudenzia, Inc. (West Chester House)

West Chester, Pennsylvania, 19382

United States

Collaborators and Investigators

Sponsor: West Chester University of Pennsylvania

Michael J Gawrysiak, PhD, PRINCIPAL_INVESTIGATOR, West Chester University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-01

Study Completion Date2024-08-20

Study Record Updates

Study Start Date2021-08-01

Study Completion Date2024-08-20

Terms related to this study

Keywords Provided by Researchers

Addiction
Relapse Prevention
Opioid
Mindfulness

Additional Relevant MeSH Terms

Opioid-use Disorder