Clinical trial NCT01056484: Mindfulness Meditation for Health
Official title: Mindfulness Meditation For Alcohol Relapse Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Dependence
Keywords: Alcohol Dependence
Alcoholism
Substance Use Disorders
Substance Abuse
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2010-01-26
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The goal of this partially-blinded, two-arm clinical trial was to test whether the Mindfulness Meditation Relapse Prevention (meditation), combined with 'standard of care' (SOC) therapy, is more effective in preventing a return to drinking than SOC alone (wait-list control) among adult recovering alcoholics. The intervention was manualized and based on existing models. It was proposed that meditation may improve outcomes of interest through reduction of the severity of stress-related relapse risk factors such as perceived stress, anxiety, depression, craving and emotion dysregulation, and the level of stress-sensitive biomarkers (cytokine interleukin-6, liver enzymes).

For this study, 123 adult alcohol dependent subjects were recruited from collaborating treatment centers, randomly assigned to one of two equal study arms, and followed for 26-weeks (Period 1, Randomized Controlled Trial, RCT). The RCT evaluated the efficacy of the meditation intervention using self-reported alcohol consumption as primary, and drinking-related harms and subject treatment satisfaction and adherence as secondary outcomes. It also gathered preliminary data on potential mechanisms of meditation action. After the completion of their 26-week RCT (Period 1), controls were eligible to receive the meditation intervention ("cross-over"), and all participants were followed-up for additional 26 weeks (non-randomized Period 2).

This study will provide evidence about the efficacy of meditation for alcohol relapse prevention, will further our understanding of relapse and the potential mechanisms of meditation action, direct future research and guide clinical decision-making.

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

Primary outcomes:
measure: Percent Heavy Drinking Days
timeFrame: 26 weeks
measure: Percent Days Abstinent From Alcohol
timeFrame: 26 weeks
measure: Time to Relapse (Resumption of Drinking)
timeFrame: 26 weeks
Secondary outcomes:
measure: Drinker Inventory of Consequences
timeFrame: 26 weeks
measure: Subject Treatment Satisfaction
timeFrame: 8 weeks
measure: Subject Treatment Adherence
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Aleksandra Zgierska, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zgierska A, Rabago D, Chawla N, Kushner K, Koehler R, Marlatt A. Mindfulness meditation for substance use disorders: a systematic review. Subst Abus. 2009 Oct-Dec;30(4):266-94. doi: 10.1080/08897070903250019.
citation: Zgierska A, Rabago D, Zuelsdorff M, Coe C, Miller M, Fleming M. Mindfulness meditation for alcohol relapse prevention: a feasibility pilot study. J Addict Med. 2008 Sep;2(3):165-73. doi: 10.1097/ADM.0b013e31816f8546.
citation: Marcus MT, Zgierska A. Mindfulness-based therapies for substance use disorders: part 1. Subst Abus. 2009 Oct-Dec;30(4):263-5. doi: 10.1080/08897070903250027. No abstract available.