Mindfulness-Based Relapse Prevention for Opioid and Alcohol Use Disorders (MBRP)

Clemson University

Status: Completed

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

Treatments: Behavioral: Mindfulness Based Relapse Prevention

Study type: Interventional

Funder types: Other

Identifiers

NCT04278352

Pro00084844

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Mindfulness Based Relapse Prevention

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness Based Relapse Prevention

Control

No Intervention group

Description:

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.