Clinical trial NCT04278352: Mindfulness-Based Relapse Prevention for Opioid and Alcohol Use Disorders
Official title: Randomized Controlled Trial of Mindfulness-Based Relapse Prevention for Opioid and Alcohol Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Opioid Abuse, in Remission
Alcohol Use Disorder
Alcohol Use Disorder, in Remission
Lead sponsor: Clemson University
Sponsor class: OTHER
Collaborators: name: Prisma Health-Upstate
First posted: 2020-02-20
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Waitlist control design
Primary purpose: PREVENTION

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.

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
* 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

Primary outcomes:
measure: Change in frequency of opioid/alcohol use
timeFrame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
measure: Change in opioid/alcohol craving
timeFrame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
measure: Change in withdrawal symptoms
timeFrame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
measure: Change in quality of life: World Health Organization Quality of Life (WHOQOL)-BREF
timeFrame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
Secondary outcomes:
measure: Change in perceived stress
timeFrame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
measure: Change in posttraumatic stress symptoms
timeFrame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
measure: Change in pain severity: Brief Pain Inventory
timeFrame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
measure: Change in medication adherence
timeFrame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
measure: Change in mindfulness skills
timeFrame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
measure: Change in emotion regulation skills
timeFrame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
measure: Change in executive functioning
timeFrame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
measure: Change in Savoring
timeFrame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
measure: Change in positive and negative affect
timeFrame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
Other outcomes:
measure: Satisfaction with Treatment
timeFrame: Assessed at 8 weeks for the experimental group and 16 weeks for the control group.
measure: Demographics
timeFrame: Assessed at baseline
measure: Adverse life event history
timeFrame: Assessed at baseline
measure: Trauma History
timeFrame: Assessed at baseline
measure: Comorbid Mental Health Conditions
timeFrame: Assessed at baseline
measure: Psychological Treatment History
timeFrame: Assessed at baseline
measure: Intervention Adherence/Mindfulness Practice Frequency
timeFrame: Assessed at 8 weeks (post-intervention for experimental group), and 16 weeks (follow-up for experimental group, post-intervention for control group)
Locations:
city: Clemson
country: United States
facility: Clemson University
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health-Upstate Internal Medicine Clinic
state: South Carolina
city: Greenville
country: United States
facility: Phoenix Center
state: South Carolina
Study officials:
affiliation: Clemson University
name: Lu Shi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: