Clinical trial NCT00006205: Alcohol Dependency Study: Combining Medication Treatment for Alcoholism
Official title: Combining Medications Treatment for Alcoholism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Alcoholism
Keywords: alcoholism
alcohol addiction
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2000-09-12
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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 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:

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Primary outcomes:
measure: Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption
timeFrame: Throughout the study
Secondary outcomes:
measure: Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Center for Addiction Research and Education
state: Virginia
city: Richmond
country: United States
facility: University of Virginia Center for Addiction Research and Education
state: Virginia
Study officials:
affiliation: University of Virginia
name: Bankole Johnson, DSc, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.