Alcohol Dependency Study: Combining Medication Treatment for Alcoholism
This study is currently recruiting participants.
Verified March 2013 by University of Virginia
Sponsor:
Bankole Johnson
Collaborator:
Information provided by (Responsible Party):
Bankole Johnson, University of Virginia
ClinicalTrials.gov Identifier:
NCT00006205
First received: September 11, 2000
Last updated: March 14, 2013
Last verified: March 2013
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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 2 |
| 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 |
Resource links provided by NLM:
Further study details as provided by University of Virginia:
Primary Outcome Measures:
- Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]Drinks per drinking day, Drinks per day, Percent Days Abstinent, BAC, CDT, GGT
Secondary Outcome Measures:
- Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]Pill Count, Q-LES-Q, SFQ, AASE, ADBS, OCDS, CIWA-Ar, CGI, TCI, MAC, AOQ, FHAM
| Estimated Enrollment: | 320 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ondansetron
Ondansetron + cognitive behavioral therapy
|
Drug: ondansetron + cognitive behavioral therapy
ondansetron (4 mcg/kg b.i.d)
Other Name: Zofran
|
|
Experimental: Topiramate
Topiramate + cognitive behavioral therapy
|
Drug: topiramate + cognitive behavioral therapy
topiramate (up to 300 mg/day)
Other Name: Topamax
|
|
Placebo Comparator: Placebo
Placebo + cognitive behavioral therapy
|
Drug: Placebo + cognitive behavioral therapy
placebo
Other Name: sugar pill
|
|
Experimental: Ondansetron + Topiramate
Ondansetron + Topiramate + cognitive behavioral therapy
|
Drug: ondansetron + topiramate + cognitive behavioral therapy
ondansetron (4 mcg/kg b.i.d) + topiramate (up to 300 mg/day)
Other Name: zofran, topamax
|
Detailed Description:
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 |
Criteria
Inclusion Criteria:
- Current diagnosis of alcohol dependence and drinking greater than or equal to 14 alcohol drinks/week for women and greater than or equal to 21 alcohol drinks/week for men in the last 30 days.
- Provide a written, informed consent.
- Good physical health and must weigh within at least 40 kg and no more than 140 kg.
- Literate in English and able to read, understand, follow instructions, and complete questionnaires accurately.
- Willingness to participate in behavioral treatments for alcoholism.
- Provide evidence of stable residence in the last month prior to enrollment in the study and have no plans to move during the next three months.
Exclusion Criteria:
Please contact site for additional information
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006205
Contacts
| Contact: Mindy Borszich | 1-888-882-2345 | mcb3x@virginia.edu |
| Contact: Eva Jenkins-Mendoza | (434) 243-0562 | emj9c@virginia.edu |
Locations
| 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 | |
Sponsors and Collaborators
Bankole Johnson
Investigators
| Principal Investigator: | Bankole Johnson, DSc, MD, PhD | University of Virginia |
More Information
Additional Information:
Publications:
| 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: | March 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Virginia:
|
alcoholism alcohol addiction |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 22, 2013