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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: | NCT00667875 |
The principal aim of this exploratory study is to examine whether the addition of aripiprazole to naltrexone will enhance efficacy over naltrexone alone in a 16-week randomized, placebo-controlled clinical trial, in which all subjects will be provided medical management as delivered in the COMBINE Study (Anton et al, 2006). To test whether medication treatment will reduce drinking compared to placebo treatment alone in the context of medical management and whether naltrexone plus aripiprazole will reduce drinking compared to naltrexone treatment alone in the context of medical management.
Condition | Intervention | Phase |
---|---|---|
Alcohol Dependence |
Drug: Placebo Drug: Naltrexone Drug: Naltrexone + Aripiprazole |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence |
Estimated Enrollment: | 60 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator |
Drug: Placebo
placebo
|
2: Active Comparator
Naltrexone
|
Drug: Naltrexone
Naltrexone (25mg or 50 mg per titration schedule)
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3: Active Comparator
Naltrexone + Aripiprazole
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Drug: Naltrexone + Aripiprazole
Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
|
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects will meet criteria for primary alcohol dependence operationalized as follows:
A. Meets the DSM IV criteria for alcohol dependence including loss of control over drinking (criterion 3) B. Has not had more than one previous inpatient medical detoxification
Exclusion Criteria:
Contact: Alicia M Baros, Ph.D. | 843-792-0073 | baros@musc.edu |
Contact: Patricia K Latham, Ph.D. | 843-792-1230 | lathampk@musc.edu |
United States, South Carolina | |
Medical University of South Carolina, Center for Drug and Alcohol Programs | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Principal Investigator: Raymond F Anton, MD |
Responsible Party: | Medical University of South Carolina ( Raymond F. Anton, M.D. ) |
Study ID Numbers: | ANTON-1R21AA017525-01, NIH Grant AA017525-01 |
Study First Received: | April 24, 2008 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00667875 |
Health Authority: | United States: Federal Government |
Alcohol Dependence Alcoholism Naltrexone Aripiprazole Substance Abuse |
Mental Disorders Naltrexone Alcoholism Substance-Related Disorders |
Disorders of Environmental Origin Alcohol-Related Disorders Aripiprazole Ethanol |
Tranquilizing Agents Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Narcotic Antagonists Psychotropic Drugs |
Central Nervous System Depressants Peripheral Nervous System Agents Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |