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Mindfulness-Based Relapse Prevention for Opioid Use Disorder

N/A
Recruiting
Led By Michael J Gawrysiak, PhD
Research Sponsored by West Chester University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Physically healthy males and females, aged 18 or older, who meet criteria for opioid use disorder as their primary diagnosis, who are enrolled in residential treatment at the collaborating study site
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed 1-, 2-, and 3-months post-residential-treatment discharge.
Awards & highlights

Study Summary

This trial will investigate whether an adjunctive treatment of mindfulness-based relapse prevention improves outcomes of medication assisted treatment for opioid use disorder patients, including reducing drug use.

Who is the study for?
This trial is for adults over 18 with opioid use disorder, enrolled in a residential treatment program and on Medication Assisted Treatment (MAT). Participants must be physically healthy, able to understand English, willing to be randomly assigned to a treatment group, and capable of following the study's procedures.Check my eligibility
What is being tested?
The study tests if Mindfulness-Based Relapse Prevention (MBRP) can improve adherence to MAT and reduce drug use after leaving a residential addiction program. It compares MBRP with standard care during the program and monitors patients for three months post-discharge.See study design
What are the potential side effects?
Since this trial involves behavioral therapy rather than medication, there are no direct side effects like those associated with drugs. However, participants may experience emotional discomfort or distress while engaging in mindfulness practices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 or older, healthy, and have opioid use disorder as my main diagnosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed 1-, 2-, and 3-months post-residential-treatment discharge.
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed 1-, 2-, and 3-months post-residential-treatment discharge. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence to Medication Assisted Treatment (MAT)
Drug Use (Urine Drug Screens)
Drug Use (self-report)
+1 more
Secondary outcome measures
Dispositional Mindfulness
MBRP Treatment Adherence
Patient Reported Outcomes - Mental Health
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)Experimental Treatment1 Intervention
Group intervention comprised of didactics and trainings in cognitive behavioral therapy relapse prevention skills and mindfulness meditation.
Group II: Treatment-As-Usual (TAU)Active Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

West Chester University of PennsylvaniaLead Sponsor
5 Previous Clinical Trials
1,224 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,455 Previous Clinical Trials
2,596,780 Total Patients Enrolled
Michael J Gawrysiak, PhDPrincipal InvestigatorWest Chester University of Pennsylvania

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the overall participant count for this research endeavor?

"Affirmative, clinicaltrials.gov states that this study is still recruiting participants as of September 11th 2021. It was first posted on August 1st and seeks to enrol 200 individuals from one medical site."

Answered by AI

What is the overarching goal of this experiment?

"The primary objective of this research is to measure the adherence to Medication Assisted Treatment (MAT) for participants 3 months after leaving a residential addiction treatment facility. Secondary objectives will be determined by assessing Dispositional Mindfulness with Feldman's Cognitive and Affective Mindfulness Scale, measuring MBRP Treatment Adherence through data on homework completion, as well as gauging Patient Reported Outcomes - Mental health with Cella et al.'s Patient-Reported Outcome Measurement Information System. Scores from these assessment tools range between 10 and 40 in terms of mindfulness, 4 and 20 regarding mental health, allowing researchers to track changes before, during and"

Answered by AI

Are there any vacancies within this research program for prospective participants?

"As per clinicaltrials.gov, this research project is recruiting participants as we speak. The initial post date was August 1st 2021 and the latest update occurred on September 11th 2021."

Answered by AI
~17 spots leftby Jul 2024