Mindfulness Based Relapse Prevention for Opioid Abuse in Remission

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Opioid Abuse in Remission+3 MoreMindfulness Based Relapse Prevention - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Opioid Abuse in Remission
  • Opioid Use Disorder
  • Alcoholism
  • Alcohol Use Disorder in Remission

Treatment Effectiveness

Study Objectives

4 Primary · 9 Secondary · Reporting Duration: Assessed at baseline

Week 16
Intervention Adherence/Mindfulness Practice Frequency
Week 16
Satisfaction with Treatment
Assessed at baseline
Adverse life event history
Comorbid Mental Health Conditions
Demographics
Psychological Treatment History
Trauma History
Week 16
Change in Savoring
Change in emotion regulation skills
Change in executive functioning
Change in frequency of opioid/alcohol use
Change in medication adherence
Change in mindfulness skills
Change in opioid/alcohol craving
Change in pain severity: Brief Pain Inventory
Change in perceived stress
Change in positive and negative affect
Change in posttraumatic stress symptoms
Change in quality of life: World Health Organization Quality of Life (WHOQOL)-BREF
Change in withdrawal symptoms

Trial Safety

Trial Design

2 Treatment Groups

Control
1 of 2
Mindfulness Based Relapse Prevention
1 of 2

Active Control

Experimental Treatment

240 Total Participants · 2 Treatment Groups

Primary Treatment: Mindfulness Based Relapse Prevention · No Placebo Group · N/A

Mindfulness Based Relapse Prevention
Behavioral
Experimental Group · 1 Intervention: Mindfulness Based Relapse Prevention · Intervention Types: Behavioral
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness Based Relapse Prevention
2012
Completed Phase 2
~440

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: assessed at baseline

Who is running the clinical trial?

Prisma Health-UpstateOTHER
74 Previous Clinical Trials
47,877 Total Patients Enrolled
Clemson UniversityLead Sponsor
27 Previous Clinical Trials
4,389 Total Patients Enrolled
Lu Shi, Ph.D.Principal InvestigatorClemson University
2 Previous Clinical Trials
132 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
Georgia100.0%
What site did they apply to?
Clemson University100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Typically responds via
Email100.0%
Most responsive sites:
  1. Clemson University: < 48 hours
Average response time
  • < 2 Days