Mindfulness-Based Relapse Prevention for Opioid and Alcohol Use Disorders

NCT04278352 | Completed DMC

• 1 other identifier: Pro00084844
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

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.

Conditions

Opioid-use Disorder; Opioid Abuse, in Remission; Alcohol Use Disorder; Alcohol Use Disorder, in Remission

Outcome Measures

Primary Outcomes (4)

• Change in frequency of opioid/alcohol use

  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.

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

• Change in opioid/alcohol craving

  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.

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

• Change in withdrawal symptoms

  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.

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

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

  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.

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

Secondary Outcomes (9)

• 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 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 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 medication adherence

  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)

Other Outcomes (7)

• Satisfaction with Treatment

  Assessed at 8 weeks for the experimental group and 16 weeks for the control group.

• Demographics

  Assessed at baseline

• Adverse life event history

  Assessed at baseline

Study Arms (2)

Mindfulness Based Relapse Prevention

EXPERIMENTAL

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.

Behavioral: Mindfulness Based Relapse Prevention

Control

NO 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.

Interventions

Mindfulness Based Relapse Prevention BEHAVIORAL

The intervention is a group skills training program that is delivered once weekly for eight weeks. Content focuses on mindfulness and cognitive-behavioral relapse prevention skills, including psychoeducation, experiential exercises, and between session homework assignments.

Mindfulness Based Relapse Prevention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• current psychosis
• dementia
• moderate to severe traumatic brain injury
• pregnancy
• active suicidality
• persistent antisocial behavior
• acute episode of an SUD (past two weeks)
• persistent self-injury requiring clinical management
• already completed or attending a mindfulness-based intervention

Sponsors & Collaborators

• Clemson University: lead
• Prisma Health-Upstate: collaborator

Study Sites (3)

Clemson University

Clemson, South Carolina, 29634, United States

Location

Prisma Health-Upstate Internal Medicine Clinic

Greenville, South Carolina, 29605, United States

Location

Phoenix Center

Greenville, South Carolina, 29607, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Alcoholism

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Alcohol-Related Disorders

Study Officials

• Lu Shi, Ph.D.

  Clemson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Waitlist control design

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 20, 2020
• Study Start: July 1, 2020
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)