Study protocol for a randomized controlled trial of mindfulness-based relapse prevention for opioid use disorders

Area of Science:

• Addiction Medicine
• Clinical Psychology
• Psychiatry

Background:

• The opioid misuse epidemic is a critical public health issue in the U.S.
• Mindfulness-Based Relapse Prevention (MBRP) is effective for substance use disorders, but its specific application to opioid use disorders requires further investigation.
• Understanding the mechanisms underlying MBRP's effectiveness in opioid use disorder treatment is crucial.

Purpose of the Study:

• To outline a randomized controlled trial protocol for MBRP in individuals with opioid use disorder.
• To evaluate the efficacy of MBRP compared to treatment as usual (TAU) in reducing opioid use.
• To explore potential moderators and mediators of MBRP's treatment outcomes.

Main Methods:

• A randomized controlled trial involving 240 participants completing opioid use disorder treatment.
• Participants will be randomized to an 8-week MBRP group intervention or TAU.
• Assessments at baseline, 8 weeks, and 16 weeks, measuring opioid use frequency, craving, withdrawal, and other secondary outcomes.

Main Results:

• The study is designed to assess the primary outcome of opioid use frequency.
• Secondary outcomes include craving, withdrawal symptoms, treatment adherence, and quality of life.
• Potential moderators (comorbid diagnoses, life events) and mediators (mindfulness, emotion regulation) will be examined.

Conclusions:

• This study will contribute to the evidence base for MBRP's efficacy in treating opioid use disorder.
• It aims to elucidate the causal mechanisms and modifying factors influencing MBRP outcomes.
• Findings will inform the development of more effective interventions for opioid use disorder.