Clinical trial NCT03882125: Mindfulness-Based Relapse Prevention for Methadone Maintenance
Official title: Mindfulness-Based Relapse Prevention for Methadone Maintenance: A Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance-Related Disorders
Keywords: mindfulness
methadone maintenance
relapse prevention
Lead sponsor: Pacific University
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The current study was designed to inform protocol adaptation, and to evaluate the feasibility, acceptability, and preliminary efficacy of a mindfulness-based intervention for methadone maintenance clients. Adults (N=15) were recruited from a methadone clinic to participate in a 6-week mindfulness course. Indices of feasibility, including recruitment, retention, data from focus groups and course satisfaction surveys, supported feasibility of the intervention. Outcome measures were self-report, and included depression, craving, PTSD symptoms, and experiential avoidance, and were assessed at baseline, postcourse, and 1-month follow-up. Data were analyzed using qualitative and quantitative approaches. Mean scores on all primary outcomes changed in the expected direction at both postcourse and 1-month follow-up assessment, although only depression and experiential avoidance reached significance. Results support feasibility and acceptability, and provide preliminary data on outcomes for future trials of mindfulness-based approaches within this client population.

Detailed description: As rates of opiate misuse rise in the United States, there areso do significant associated health, and financial consequences to afflicted individuals, their families, and society at large. Methadone Maintenance Therapy (MMT) is one evidence-based approach to treating individuals with opiate addiction, yet supplemental psychosocial treatment to support this approach is lacking. Mindfulness-Based Relapse Prevention (MBRP) has shown to be efficacious in various substance use populations, but has yet to be assessed with MMT clients. The current study was designed to inform protocol adaptation for to MMT clients, and to evaluate the feasibility, acceptability, and preliminary efficacy of a MBRP for this population. The sample consisted of adults (N=15) recruited from a methadone clinic to participate in a 6-week MBRP course. Indices of feasibility, including recruitment, retention, data from focus groups and course satisfaction surveys, supported feasibility of the intervention. Outcome measures were self-report, and included self-compassion, depression, craving, PTSD symptoms, and experiential avoidance, and were assessed at baseline, postcourse, and 1-month follow-up. Data were analyzed using qualitative and quantitative approaches. Mean scores on all primary outcomes changed in the expected direction at both postcourse and 1-month follow-up assessment, although only depression and experiential avoidance reached significance. Results from this initial pilot support feasibility and acceptability, and provide preliminary data on outcomes for future trials of mindfulness-based approaches within the MMT community.

Eligibility criteria: Inclusion Criteria:

* Clearance from clinic staff
* Currently enrolled in a methadone maintenance program
* Agree to complete assessment questionnaires and attend treatment sessions
* Fluent in English

Exclusion Criteria:

* Indication of active psychosis
* Participation in past mindfulness-based relapse prevention group

Primary outcomes:
measure: Acceptability - Satisfaction with the Course
timeFrame: post course (6 weeks)
measure: Acceptability - Enactment of Learned Skills
timeFrame: post course (6 weeks)
Secondary outcomes:
measure: Depression
timeFrame: 1 month
measure: Anxiety
timeFrame: 1 month
measure: Craving
timeFrame: 1 month
measure: Trauma symptoms
timeFrame: 1 month
measure: Experiential avoidance
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
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