Phase 2
N=123
Mindfulness Meditation for Health
Alcohol Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01056484 ↗Enrolled (actual)
123
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Percent Heavy Drinking Days — 3.8; 3.0 percentage of heavy drinking days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mindfulness Based Relapse Prevention for Alcohol Dependence (Behavioral); "Wait-list" control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Heavy Drinking Days |
3.8; 3.0 | — |
| PRIMARY Percent Days Abstinent From Alcohol |
88.5; 94.1 | — |
| PRIMARY Time to Relapse (Resumption of Drinking) |
29.0 | — |
| SECONDARY Drinker Inventory of Consequences |
11.3; 16.5 | — |
| SECONDARY Subject Treatment Satisfaction |
5.5 | — |
| SECONDARY Subject Treatment Adherence |
71.9 | — |
Summary
The purpose of this 52-week clinical trial is to see if the meditation-based intervention, adjunctive to standard of care therapy, can reduce relapse and improve psychological health among adults recovering from alcohol dependence.
Eligibility Criteria
Inclusion Criteria
- Alcohol dependence diagnosis
- Completed at least 2 weeks of IOP or (IOP equivalent=at least 2 days per week) for alcohol dependence
- Sober since beginning of outpatient treatment
- English fluency; ability to fill out surveys
- Permanent home address and telephone
- At least 18 years old
- Score >13 on the Perceived Stress Scale
Exclusion Criteria
- Pregnant
- Alcohol abstinence >14 weeks before enrollment
- Current, regular meditation
- Pre-existing bipolar, schizophrenia, or delusional disorder
- Regular drug use (other than tobacco) in last 2 weeks
- Inability to reliably participate
Data sourced from ClinicalTrials.gov (NCT01056484). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.