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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: | NCT00382642 |
The purpose of this study is to learn whether ondansetron is safe and effective in the treatment of alcohol dependence. We also want to learn whether the study drug ondansetron combined with Cognitive Behavioral Therapy will assist researchers to determine whether having a certain gene is responsible for determining how a person benefits or does not benefit from the use of ondansetron for alcohol dependence.
Condition | Intervention | Phase |
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Alcohol Dependence |
Drug: Ondansetron Behavioral: Group behavioral therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Pharmacological Treatment for Alcoholism |
Estimated Enrollment: | 320 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Arm 1 = Ondansetron + group behavioral therapy
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Drug: Ondansetron
13 week outpatient trial
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2: Placebo Comparator
Arm 2 = Placebo + group behavioral therapy
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Behavioral: Group behavioral therapy
13 week outpatient trial
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This is a 13 week outpatient clinical trial. Participants will either receive ondansetron or placebo and behavioral therapy. There is a 1, 2, and 3 month post-study follow up visit.Screening for this study is initially done over the telephone and takes 15-20 minutes. If participants are eligible after the initial screen, they will be invited to come in for a more thorough in house screen which takes about 5 to 6 hours. The screening will include a physical exam, review of medical, alcohol and drug histories and blood collection. If participants are found to be eligible after the in house screen, they will be enrolled in the 13 week outpatient clinical trial.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
naltrexone), glutamate antagonists (e.g., acamprosate), serotonin re-uptake inhibitors (e.g. fluoxetine), serotonin antagonists (e.g. ritanserin or buspirone), other antidepressants (e.g. tricyclic antidepressants or monoamine oxidase inhibitors), dopamine antagonists (e.g. haloperidol), calcium channel antagonists (e.g. isradipine), or compounds with actions similar to disulfiram (antabuse) or nicotine.
United States, Virginia | |
UVA Center for Addiction Research and Education | |
Charlottesville, Virginia, United States, 22911 |
Principal Investigator: | Bankole Johnson, M.D., Ph.D. | University of Virginia |
Responsible Party: | University of Virginia Center for Addiction Research and Education ( Bankole Johnson, M.D., Study Principal Investigator ) |
Study ID Numbers: | R01AA10522-11 |
Study First Received: | September 28, 2006 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00382642 History of Changes |
Health Authority: | United States: Food and Drug Administration |
alcoholism, alcohol disorder, drinking,alcohol |
Neurotransmitter Agents Tranquilizing Agents Psychotropic Drugs Central Nervous System Depressants Disorders of Environmental Origin Antiemetics Antipsychotic Agents Serotonin Mental Disorders |
Alcoholism 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 Psychotropic Drugs Antiemetics Disorders of Environmental Origin Serotonin Antagonists 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 Alcoholism Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents |