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| Sponsor: | University of Virginia |
|---|---|
| Collaborator: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| Information provided by: | University of Virginia |
| ClinicalTrials.gov Identifier: | NCT00768508 |
Purpose
This study would like to test whether the combination of ondansetron and naltrexone will be superior to either medication alone or placebo in the treatment of alcohol dependence.
| Condition | Intervention | Phase |
|---|---|---|
|
Alcoholism |
Drug: Ondansetron Drug: Naltrexone Drug: Ondansetron + Naltrexone Other: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
| Official Title: | Combined Pharmacotherapies for Alcoholism |
| Estimated Enrollment: | 320 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Ondansetron: Experimental
Ondansetron 4 ug/kg b.i.d.),
|
Drug: Ondansetron
Ondansetron 4 ug/kg b.i.d.),
|
|
Naltrexone: Experimental
Naltrexone 50 mg/day
|
Drug: Naltrexone
Naltrexone 50 mg/day
|
|
Ondansetron + Naltrexone: Experimental
Combination of Ondansetron 4 ug/kg bid and Naltrexone 50 mg/day
|
Drug: Ondansetron + Naltrexone
Combination of ondansetron and naltrexone
|
| Placebo: Placebo Comparator |
Other: Placebo
Placebo comparator
|
We propose to conduct a 13 week randomized, controlled clinical trial to evaluate the safety and efficacy of ondansetron and naltrexone alone and in combination.Eligible subjects will be randomized to placebo, ondansetron, naltrexone, or ondansetron + naltrexone treatments. All subjects will receive a weekly CBT (Cognitive Behavioral Therapy)sessions.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Mindy Borszich, B.A. | 1-888-882-2345 | uvacare@virginia.edu |
| United States, Virginia | |
| UVA CARE | Recruiting |
| Charlottesville, Virginia, United States, 22911 | |
| UVA CARE Richmond | Recruiting |
| Richmond, Virginia, United States, 23294 | |
| Principal Investigator: | Bankole Johnson, DSc,MD,PhD | University of Virginia |
More Information
| Responsible Party: | University of Virginia ( Bankole Johnson ) |
| Study ID Numbers: | 12790, R01 AA012964 |
| Study First Received: | October 6, 2008 |
| Last Updated: | January 19, 2010 |
| ClinicalTrials.gov Identifier: | NCT00768508 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Alcohol Alcohol Dependence Alcoholism |
|
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 |