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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: | NCT00183222 |
The purpose of this study is to determine whether naltrexone (an opiate blocking agent approved for the treatment of alcohol dependence), ondansetron a serotonin 3 antagonist medication approved to treat nausea) or their combination are effective in the reduction of alcohol craving and drinking compared to placebo.
Condition | Intervention | Phase |
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Alcohol Dependence |
Drug: naltrexone (up to 50 mg/day) for 8 days; ondansetron (0.25 mg twice a day) for 8 days |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Alcohol Research Center Grant. Component #1. COMBINING MEDICATIONS: ALCOHOL REACTIVITY AND CONSUMPTION |
Estimated Enrollment: | 160 |
Study Start Date: | May 2005 |
Study Completion Date: | December 2005 |
Non-treatment seeking individuals meeting criteria for alcohol dependence N=160) will be recruited through advertisement and paid for their participation. Alcoholics, after baseline evaluation, will be assigned through urn randomization (using a double dummy placebo controlled design) to one of four experimental groups, naltrexone (50 mg/day) (N=40), ondansetron (0.25 mg twice a day) (N=40), naltrexone and ondansetron (N=40) or placebos (N=40). Subjects will take the study drugs for 8 days (day 1-5 being the natural observation period). After a minimum of 48 hours of abstinence from alcohol day 6-8) they will undergo an alcohol administration (priming dose) and motivated free choice drinking procedure (on day 8). Alcoholic subjects will receive a brief counseling session at the end of the study to enhance their awareness of problem drinking and to motivate them to seek treatment. Referral for treatment will be offered.A subset of subjects from each medication group (N=15) will undergo a functional MRI brain scan with cue stimulation on day 7, on the evening before the alcohol administration paradigm.
A smaller group of social drinker controls (N=16), recruited and paid in a similar fashion, will be randomly assigned to the same medication groups (4 per group). They will be used as procedure controls for the alcohol administration lab study and as a comparison/contrast group for the brain imaging sub-study.
Ages Eligible for Study: | 21 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Inclusion Criteria (alcohol dependent group):
Inclusion Criteria (social drinker group):
Inclusion for fMRI imaging sub-study (see methodology section for rationale):
Exclusion Criteria:
United States, South Carolina | |
Center for Drug and Alcohol Programs, Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425 |
Principal Investigator: | Raymond F Anton, MD | Medical University of South Carolina |
Study ID Numbers: | NIAAAANT010761-2005a, NIH Grant P50 AA010761 |
Study First Received: | September 13, 2005 |
Last Updated: | November 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00183222 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Alcohol dependence Alcoholism Craving |
Neurotransmitter Agents Tranquilizing Agents Narcotic Antagonists Psychotropic Drugs Central Nervous System Depressants Disorders of Environmental Origin Antiemetics Narcotics Antipsychotic Agents Serotonin |
Mental Disorders Alcoholism Naltrexone Substance-Related Disorders Antipruritics Anti-Anxiety Agents Alcohol-Related Disorders Ondansetron Peripheral Nervous System Agents Ethanol |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Narcotic Antagonists Psychotropic Drugs Disorders of Environmental Origin Antiemetics Serotonin Antagonists Sensory System Agents Mental Disorders Therapeutic Uses Substance-Related Disorders Antipruritics Alcohol-Related Disorders |
Ondansetron Dermatologic Agents Tranquilizing Agents Gastrointestinal Agents Central Nervous System Depressants Antipsychotic Agents Pharmacologic Actions Serotonin Agents Autonomic Agents Naltrexone Alcoholism Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents |