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Mindfulness-Based Relapse Prevention for Opioid Abuse and Alcoholism (MBRP Trial)
N/A
Waitlist Available
Led By Lu Shi, Ph.D.
Research Sponsored by Clemson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
able to attend intervention sessions
over 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline
Awards & highlights
MBRP Trial Summary
This trial will examine the outcomes of the mindfulness-based relapse prevention program for 240 people who have completed treatment for opioid or alcohol use disorders. The program integrates mindfulness skills training with cognitive-behavioral relapse prevention strategies.
Who is the study for?
This trial is for adults over 18 who have finished treatment for opioid or alcohol use disorders within the last two months, can attend sessions, and are under ongoing care by a behavioral health provider. It's not for pregnant individuals, those with severe brain injury, active psychosis or suicidality, recent substance abuse episodes, persistent antisocial behavior or self-injury issues.Check my eligibility
What is being tested?
The study tests a program called Mindfulness-Based Relapse Prevention (MBRP) to see if it helps people stay off opioids and alcohol after treatment. Participants will learn mindfulness skills combined with strategies to prevent relapse. The study will track their substance use frequency, cravings, withdrawal symptoms and overall quality of life.See study design
What are the potential side effects?
Since MBRP involves group therapy and mental exercises rather than medication there aren't typical side effects like you'd expect from drugs; however participants may experience emotional discomfort when confronting addiction-related thoughts or feelings during sessions.
MBRP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can attend all required treatment sessions.
Select...
I am over 18 years old.
MBRP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in frequency of opioid/alcohol use
Change in opioid/alcohol craving
Change in quality of life: World Health Organization Quality of Life (WHOQOL)-BREF
+1 moreSecondary outcome measures
Change in Savoring
Change in emotion regulation skills
Change in executive functioning
+6 moreOther outcome measures
Adverse life event history
Comorbid Mental Health Conditions
Demographics
+4 moreMBRP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness Based Relapse PreventionExperimental Treatment1 Intervention
MBRP is a group aftercare program that integrates mindfulness skills training with cognitive-behavioral relapse prevention strategies. The intervention consists of eight weekly two-hour group therapy sessions, delivered by two facilitators with 6-12 people. The experimental group will complete the intervention in weeks 1-8. They will continue treatment as usual for weeks 9-16.
Group II: ControlActive Control1 Intervention
The waitlist control group will not receive the MBRP program during weeks 1-8 and will continue treatment as usual. During weeks 9-16, the control group will receive MBRP.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness Based Relapse Prevention
2012
Completed Phase 2
~450
Find a Location
Who is running the clinical trial?
Prisma Health-UpstateOTHER
82 Previous Clinical Trials
42,927 Total Patients Enrolled
Clemson UniversityLead Sponsor
33 Previous Clinical Trials
5,882 Total Patients Enrolled
Lu Shi, Ph.D.Principal InvestigatorClemson University
2 Previous Clinical Trials
132 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with a substance use disorder for opioids or alcohol according to the DSM-5 criteria.You currently have a mental condition called psychosis.You are pregnant.I have had a serious head injury.You have had a recent episode of substance use disorder (within the past two weeks).You consistently behave in a way that is harmful or disruptive to others.I can attend all required treatment sessions.You must be able to speak and understand English.I am over 18 years old.You currently have thoughts or plans of harming yourself.You frequently hurt yourself and need medical attention to manage your injuries.I finished treatment for opioid or alcohol use disorder in the last 8 weeks.You have dementia (a condition that affects thinking and memory).I have completed or am currently in a mindfulness program.
Research Study Groups:
This trial has the following groups:- Group 1: Mindfulness Based Relapse Prevention
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being included in this clinical trial?
"Affirmative, according to clinicaltrials.gov the trial was posted on July 1st 2020 and modified last April 20th 2022. This medical experiment is currently searching for 240 participants across 3 different sites."
Answered by AI
Is enrollment in this experiment currently available?
"Indeed, the clinical trial is currently recruiting patients. This research endeavor was posted on July 1st 2020 and has been edited as recently as April 20th 2022, according to data hosted by clinicaltrials.gov."
Answered by AI
What primary purpose does this clinical trial have?
"This medical trial aims to gauge the efficacy of its intervention over a Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group) time frame by measuring Change in withdrawal symptoms. Secondary outcomes include Change in perceived stress (evaluated using Warttig's Short Form Perceived Stress Scale - PSS-4; 0 to 56 score range with higher scores signifying lower stress levels), Change in emotion regulation skills (assessed via Kaufman's Difficulties in Emotion Regulation Scale - DERS; 18 to 90 score range with greater impairments"
Answered by AI
Who else is applying?
What state do they live in?
Georgia
What site did they apply to?
Clemson University
Prisma Health-Upstate Internal Medicine Clinic
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Clemson University: < 48 hours
Average response time
- < 2 Days
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