Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
University of Virginia |
---|---|
Information provided by: | University of Virginia |
ClinicalTrials.gov Identifier: | NCT00678457 |
This study would like to test whether the combination of ondansetron and olanzapine will be superior to placebo at decreasing self-reported heavy drinking among early onset alcoholics.
Condition | Intervention | Phase |
---|---|---|
Alcohol Dependence |
Drug: Ondansetron Drug: Olanzapine Drug: Placebo |
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: | Ondansetron With Olanzapine for the Treatment of Alcohol Dependence: A Preliminary Clinical Trial |
Enrollment: | 40 |
Study Start Date: | January 2007 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
ondansetron/olanzapine: Experimental
ondansetron (4 μg/kg b.i.d.) olanzapine (9 μg/kg) |
Drug: Ondansetron
ondansetron (4 μg/kg b.i.d.)
Drug: Olanzapine
olanzapine (9, 18, and 36 μg/kg)
|
placebo: Placebo Comparator
placebo
|
Drug: Placebo
placebo
|
Target population: We will enroll male and female who meet DSM IV criteria for alcohol dependence and who are currently drinking equal or more than 21 alcohol units/week for women and equal or more than 28 alcohol units/week for men in the 7 day period prior to enrollment.
This is a double-blind placebo-controlled study. Eligible subjects will be randomized to ondansetron (4 ug/kg) and olanzapine (9, 18, 36 ug/kg) vs placebo. All subjects will participate in a 9 week regimen of weekly BBCET and outpatient medication treatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Virginia | |
UVA CARE | |
Charlottesville, Virginia, United States, 22911 | |
UVA CARE Richmond | |
Richmond, Virginia, United States, 23294 |
Principal Investigator: | Bankole Johnson, DSc, MD, PhD | University of Virginia |
Responsible Party: | University of Virginia ( Bankole Johnson, DSc, M.D., Ph.D. ) |
Study ID Numbers: | TO45228, IRB-HSR #12816 |
Study First Received: | May 8, 2008 |
Last Updated: | May 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00678457 |
Health Authority: | United States: Food and Drug Administration |
alcohol dependence alcohol abuse drinking alcohol |
Mental Disorders Alcoholism Olanzapine Substance-Related Disorders Disorders of Environmental Origin |
Alcohol-Related Disorders Ondansetron Serotonin Ethanol |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Gastrointestinal Agents Central Nervous System Depressants Antiemetics Antipsychotic Agents Serotonin Uptake Inhibitors |
Pharmacologic Actions Serotonin Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses Antipruritics Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Dermatologic Agents |