Mindfulness Meditation for Health

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01056484
Study type	Interventional
Source	University of Wisconsin, Madison
Contact
Status	Completed
Phase	Phase 2
Start date	September 2009
Completion date	May 2013

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02901041` - Interdisciplinary Study of A Novel Anticonvulsant in Alcoholism	Phase 3
Completed	`NCT03340051` - Remote Alcohol Monitoring and Episodic Thinking	N/A
Completed	`NCT02486900` - Neurofeedback & Alcohol Dependence	N/A
Completed	`NCT02705898` - Lifestyle Physical Activity Intervention for Depressed Alcohol Dependent Women	N/A
Completed	`NCT02179749` - Mifepristone Treatment of Alcohol Use Disorder	Phase 2
Completed	`NCT02197598` - Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed Use	Phase 4
Recruiting	`NCT02385643` - The Efficacy of A Smartphone-based Support System to Reinforce Alcohol Abstinence in Treatment-seeking Patients	N/A
Completed	`NCT01828866` - Eye Movement Desensitization and Reprocessing (EMDR) in Alcohol Dependent Patients	N/A
Terminated	`NCT01408641` - Topiramate for Alcohol Use in Posttraumatic Stress Disorder	N/A
Active, not recruiting	`NCT01182766` - New Treatment for Alcohol and Nicotine Dependence	Phase 2/Phase 3
Completed	`NCT02193204` - Chronic Alcohol, Stress Inflammatory Response and Relapse Risk	N/A
Completed	`NCT01342549` - Treatment Strategy for Alcohol Use Disorders in Veterans With TBI	Phase 3
Completed	`NCT01176591` - HBPL Study of the Impact of the NK1 Antagonist Aprepitant	Phase 2
Completed	`NCT01165541` - A Study of Quetiapine and Mirtazapine for the Treatment of Alcohol Dependency	Phase 2
Completed	`NCT00585780` - Prazosin to Reduce Stress-Induced Alcohol/Drug Craving and Relapse	Phase 1/Phase 2
Completed	`NCT00607620` - Disseminating Organizational SBI Services at Trauma Centers	N/A
Completed	`NCT00884884` - Aripiprazole and Topiramate on Free-Choice Alcohol Use	Phase 2/Phase 3
Completed	`NCT00463346` - Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism	Phase 3
Completed	`NCT00226694` - Alcohol and Gender Effects on Stress Circuit Function	N/A
Completed	`NCT00746785` - A New Pharmacotherapy for Alcohol Dependence: Olanzapine	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.