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Mindfulness Meditation for Health

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01056484
First received: January 22, 2010
Last updated: April 19, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this 52-week randomized controlled trial is to see if the meditation-based therapy can reduce relapse and improve psychological health among adults recovering from alcohol dependence.


Condition Intervention Phase
Alcohol Dependence
 Behavioral: Mindfulness Based Relapse Prevention for Alcohol Dependence
Other: "Wait-list" control
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness Meditation For Alcohol Relapse Prevention

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism
U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Percent days abstinent from alcohol [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Drinking Related Negative Consequences [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Subject Treatment Satisfaction [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Subject Treatment Adherence [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 123
Study Start Date: September 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Meditation
Mindfulness Based Relapse Prevention intervention + Standard of Care therapy
 Behavioral: Mindfulness Based Relapse Prevention for Alcohol Dependence
All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and "traditional" cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study.
Other Names:
  • Mindfulness Meditation
  • Meditation
  • Mindfulness
  • Relapse Prevention
Wait-list control
Standard of Care therapy only
 Other: "Wait-list" control
'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC.
Other Names:
  • Standard of Care
  • Treatment as Usual

Detailed Description:

Relapse prevention is one of the most challenging issues in the treatment of alcohol dependence and calls for the development of new therapeutic modalities. Mindfulness meditation (meditation), a popular mind-body therapy, is a promising treatment for substance use disorders (SUDs). However, there have been no published rigorous studies evaluating the effects of meditation in alcohol dependence.

This unblinded, 2-arm randomized controlled trial (RCT) will 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 is manualized and based on existing models. For this study, 112 adult alcohol dependent subjects will be recruited from collaborating treatment centers, randomly assigned to one of two equal study arms, and followed for 52-weeks. This RCT will evaluate 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 will also gather preliminary data on potential mechanisms of meditation action. It is 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).

The proposed study will provide rigorous 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01056484

Locations
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
National Institutes of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Aleksandra Zgierska, MD PhD University of Wisconsin, Madison
  More Information

Additional Information:
brief description of the findings from the pilot study  This link exits the ClinicalTrials.gov site

Publications:
Zgierska A, Rabago D, Zuelsdorff M, Miller M, Coe C, Fleming MF. Mindfulness Meditation for Relapse Prevention in Alcohol Dependence: a feasibility pilot study. J Addiction Med, 2008, 2(3):165-173

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01056484     History of Changes
Other Study ID Numbers: H-2009-0118, 1K23AA017508-01A1
Study First Received: January 22, 2010
Last Updated: April 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Alcohol Dependence
Alcoholism
Substance Use Disorders
Substance Abuse

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 13, 2013