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| Sponsor: | Bankole Johnson |
|---|---|
| Collaborator: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| Information provided by (Responsible Party): | Bankole Johnson, University of Virginia |
| ClinicalTrials.gov Identifier: | NCT00006205 |
Purpose
The purpose of this study is to learn whether ondansetron and topiramate either alone or in combination is safe and effective in the treatment of alcohol dependence. This 13 week out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will receive ondansetron and topiramate either alone or in combination or a placebo coupled with psychotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Alcoholism |
Drug: ondansetron + cognitive behavioral therapy Drug: topiramate + cognitive behavioral therapy Drug: Placebo + cognitive behavioral therapy Drug: ondansetron + topiramate + cognitive behavioral therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Combining Medications Treatment for Alcoholism |
| Estimated Enrollment: | 320 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ondansetron |
Drug: ondansetron + cognitive behavioral therapy
ondansetron (4 mcg/kg b.i.d)
Other Name: Zofran
|
| Experimental: Topiramate |
Drug: topiramate + cognitive behavioral therapy
topiramate (up to 300 mg/day)
Other Name: Topamax
|
| Placebo Comparator: Placebo |
Drug: Placebo + cognitive behavioral therapy
placebo
Other Name: sugar pill
|
| Experimental: Ondansetron + Placebo |
Drug: ondansetron + topiramate + cognitive behavioral therapy
ondansetron (4 mcg/kg b.i.d) + topiramate (up to 300 mg/day)
Other Name: zofran, topamax
|
This study is a 13 week clinical trial. During the 13 weeks participants receive placebo, ondansetron and topiramate alone or in combination. During the 13 weeks participants come to an outpatient clinic to receive the study medication, physical checks, and cognitive behavioral therapy. The duration of the weekly visit is 3 hours. 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 there is nothing found to make someone ineligible to participate, they come to the out-patient clinic for a more thorough in-clinic screening.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Please contact site for additional information
Contacts and Locations| Contact: Mindy Borszich | 1-888-882-2345 | mcb3x@virginia.edu |
| Contact: Eva Jenkins-Mendoza | (434) 243-0562 | emj9c@virginia.edu |
| United States, Virginia | |
| University of Virginia Center for Addiction Research and Education | Recruiting |
| Charlottesville, Virginia, United States, 22911 | |
| Contact: Mindy Borszich 888-882-2345 mcb3x@virginia.edu | |
| Contact: Eva Jenkins-Mendoza (434)243-0562 emj9c@virginia.edu | |
| Principal Investigator: Bankole Johnson, DSc, MD, PhD | |
| Sub-Investigator: Nassima Ait-Daoud Tiouririne, MD | |
| University of Virginia Center for Addiction Research and Education | Recruiting |
| Richmond, Virginia, United States, 23294 | |
| Contact: Mindy Borszich 888-882-2345 mcb3x@virginia.edu | |
| Contact: Eva Jenkins-Mendoza (434)243-0562 emj9c@virginia.edu | |
| Principal Investigator: Bankole Johnson, DSc, MD, PhD | |
| Sub-Investigator: Nassima Ait-Daoud Tiouririne, MD | |
| Principal Investigator: | Bankole Johnson, DSc, MD, PhD | University of Virginia |
More Information
| Responsible Party: | Bankole Johnson, Chair of Psychiatry and Neurobehavioral Sciences, University of Virginia |
| ClinicalTrials.gov Identifier: | NCT00006205 History of Changes |
| Other Study ID Numbers: | NIAAAJOH1052207A1, R01AA013964 |
| Study First Received: | September 11, 2000 |
| Last Updated: | February 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
alcoholism alcohol addiction |
|
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Ondansetron Topiramate Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Antipruritics |
Dermatologic Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Anti-Anxiety Agents Anticonvulsants Neuroprotective Agents Protective Agents Anti-Obesity Agents |
