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Sponsored by: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
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Information provided by: | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
ClinicalTrials.gov Identifier: | NCT00000456 |
This study will compare cognitive behavioral therapy with a time-limited motivational enhancement therapy to which naltrexone (Revia) or placebo medication is added. In this randomized clinical trial, 160 alcohol-dependent outpatients, after 5 days of abstinence, will receive one of the two psychosocial therapies and either naltrexone (Revia) or placebo for a 12-week treatment period. Abstinence rates, alcohol use, and time to alcohol relapse will be evaluated in all four groups along with measures of alcohol craving, biological measures of alcohol consumption, drinking consequences, changes in self-confidence for avoiding alcohol, and medication compliance. All study participants will be assessed for measures of outcome variables at 3 and 6 months after completing the treatment protocol.
Condition | Intervention | Phase |
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Alcoholism Alcohol Dependence |
Drug: naltrexone (Revia) Behavioral: cognitive behavior therapy Behavioral: motivational enhancement therapy |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Comparison of Cognitive Behavioral Therapy and Motivational Enhancement Therapy Plus Naltrexone for Alcoholism |
Ages Eligible for Study: | 21 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, South Carolina | |
Medical Univ. of South Carolina | |
Charleston, South Carolina, United States, 29425 |
Principal Investigator: | Ray Anton, MD | Medical University of South Carolina |
Study ID Numbers: | NIAAAANT09568 |
Study First Received: | November 2, 1999 |
Last Updated: | November 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00000456 |
Health Authority: | United States: Federal Government |
Alcoholism Alcohol Dependence Naltrexone Cognitive Behavioral Therapy |
Mental Disorders Naltrexone Alcoholism Substance-Related Disorders |
Disorders of Environmental Origin Alcohol-Related Disorders Ethanol |
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Narcotic Antagonists |
Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions |