Alcohol Dependency Study: Combining Medication Treatment for Alcoholism
Combining Medications Treatment for Alcoholism
2 other identifiers
interventional
320
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2005
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2000
CompletedFirst Posted
Study publicly available on registry
September 12, 2000
CompletedStudy Start
First participant enrolled
March 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMarch 15, 2013
March 1, 2013
8.3 years
September 11, 2000
March 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption
Drinks per drinking day, Drinks per day, Percent Days Abstinent, BAC, CDT, GGT
Throughout the study
Secondary Outcomes (1)
Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors
Throughout the study
Study Arms (4)
Ondansetron
EXPERIMENTALOndansetron + cognitive behavioral therapy
Topiramate
EXPERIMENTALTopiramate + cognitive behavioral therapy
Placebo
PLACEBO COMPARATORPlacebo + cognitive behavioral therapy
Ondansetron + Topiramate
EXPERIMENTALOndansetron + Topiramate + cognitive behavioral therapy
Interventions
ondansetron (4 mcg/kg b.i.d)
topiramate (up to 300 mg/day)
ondansetron (4 mcg/kg b.i.d) + topiramate (up to 300 mg/day)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Please contact site for additional information
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Virginia Center for Addiction Research and Education
Charlottesville, Virginia, 22911, United States
University of Virginia Center for Addiction Research and Education
Richmond, Virginia, 23294, United States
Related Publications (1)
Johnson BA. An overview of the development of medications including novel anticonvulsants for the treatment of alcohol dependence. Expert Opin Pharmacother. 2004 Sep;5(9):1943-55. doi: 10.1517/14656566.5.9.1943.
PMID: 15330732BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bankole Johnson, DSc, MD, PhD
University of Virginia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chair of Psychiatry and Neurobehavioral Sciences
Study Record Dates
First Submitted
September 11, 2000
First Posted
September 12, 2000
Study Start
March 1, 2005
Primary Completion
June 1, 2013
Study Completion
December 1, 2013
Last Updated
March 15, 2013
Record last verified: 2013-03