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Clinical Trials/NCT04278352
NCT04278352
Completed
Not Applicable

Randomized Controlled Trial of Mindfulness-Based Relapse Prevention for Opioid and Alcohol Use Disorders

Clemson University3 sites in 1 country11 target enrollmentJuly 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid-use Disorder
Sponsor
Clemson University
Enrollment
11
Locations
3
Primary Endpoint
Change in frequency of opioid/alcohol use
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

A randomized controlled trial will examine mindfulness-based relapse prevention (MBRP) program outcomes for 240 individuals who have completed treatment for opioid or alcohol use disorders. MBRP is a group aftercare program that integrates mindfulness skills training with cognitive-behavioral relapse prevention strategies. Primary outcomes will include frequency of opioid/alcohol use, craving, withdrawal, and quality of life. Secondary outcomes include time to first opioid/alcohol use, adherence to medication-assisted treatment plans, perceived stress, posttraumatic stress symptoms, and chronic pain. We will also examine the following potential moderators of intervention outcomes: comorbid diagnoses, life events history, and MBRP intervention adherence. In addition, we will examine the following mediators of intervention outcome: mindfulness skills, emotion regulation skills, executive functioning skills, savoring, and positive and negative affect.

Detailed Description

A randomized controlled trial will examine mindfulness-based relapse prevention (MBRP) program outcomes for 240 individuals who have completed treatment for opioid or alcohol use disorders. Participants will be recruited from outpatient medical clinics and substance use recovery centers. They will be assigned to an intervention group (Group 1) or waitlist control (Group 2), completing assessments at baseline, 8, and 16 weeks. Group 1 will receive the intervention in weeks 1-8 and group 2 will receive the intervention in weeks 9-16. MBRP is a group aftercare program that integrates mindfulness skills training with cognitive-behavioral relapse prevention strategies. Primary outcomes will include frequency of opioid/alcohol use, craving, withdrawal, and quality of life. Secondary outcomes include time to first opioid/alcohol use, adherence to medication-assisted treatment plans, perceived stress, posttraumatic stress symptoms, and chronic pain. We will also examine the following potential moderators of intervention outcomes: comorbid diagnoses, life events history, and MBRP intervention adherence. In addition, we will examine the following mediators of intervention outcome: mindfulness skills, emotion regulation skills, executive functioning skills, savoring, and positive and negative affect.

Registry
clinicaltrials.gov
Start Date
July 1, 2020
End Date
August 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Heidi Zinzow

Professor

Clemson University

Eligibility Criteria

Inclusion Criteria

  • over 18 years of age
  • completed behavioral health treatment for Opioid Use Disorder (OUD) or Alcohol Use Disorder (AUD) within the previous eight weeks
  • continues to be followed by a behavioral health provider
  • meets DSM-5 criteria for OUD or AUD
  • English fluency
  • able to attend intervention sessions
  • Exclusion Criteria
  • current psychosis
  • moderate to severe traumatic brain injury
  • pregnancy

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in frequency of opioid/alcohol use

Time Frame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)

Frequency and time to first use will be assessed with both self-timeline follow-back method and collateral timeline follow-back for the past 60 days (Wray et al 2016; Donohue et al., 2004), as well as urine samples.

Change in opioid/alcohol craving

Time Frame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)

We will assess craving with the Penn Alcohol Craving Scale, which will be modified to assess opioid craving for individuals with opioid use disorder (Garland et al., 2014; Flannery, Volpicelli, \& Pettinati, 1999). The Penn Scale is a 5 item self-report measure with scores ranging from 0 to 30, with higher scores indicating higher levels of craving.

Change in quality of life: World Health Organization Quality of Life (WHOQOL)-BREF

Time Frame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)

Quality of life will be assessed with the World Health Organization Quality of Life (WHOQOL)-BREF. The WHOQOL-BREF is a 26 item self-report measure that assesses four domains: physical health, psychological, social relationships, and environment. Transformed scores range from 0 to 100 for each of the four domains, with higher scores indicating greater quality of life.

Change in withdrawal symptoms

Time Frame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)

Assessed with The Short Opiate Withdrawal Scale (Gossop, 1990) and the Short Alcohol Withdrawal Scale (Gossop et al., 2002). The Short Opiate Withdrawal Scale and the Short Alcohol Withdrawal Scale are each10 item self-report scales, with scores ranging from 0 to 30, with higher scores indicating more withdrawal symptoms.

Secondary Outcomes

  • Change in posttraumatic stress symptoms(Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group))
  • Change in medication adherence(Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group))
  • Change in executive functioning(Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group))
  • Change in pain severity: Brief Pain Inventory(Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group))
  • Change in mindfulness skills(Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group))
  • Change in emotion regulation skills(Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group))
  • Change in perceived stress(Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group))
  • Change in Savoring(Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group))
  • Change in positive and negative affect(Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group))

Study Sites (3)

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