Alcohol Dependency Study: Combining Medication Treatment for Alcoholism

Condition(s) targeted: Alcoholism

Intervention: ondansetron (Drug); topiramate (Drug); cognitive behavioral (Behavioral); ondansetron + topiramate (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Official(s) and/or principal investigator(s):
Bankole Johnson, M.D., Principal Investigator, Affiliation: University of Virginia Center for Addiction Research and Education

Overall contact:
Mindy Borszich, BA, Phone: (434) 243-0549, Email: uvacare@virginia.edu

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.

Official title: Combining Medications Treatment for Alcoholism

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Efficacy Study

Primary outcome: Reduction of alcohol consumption

Secondary outcome: Abstinence from alcohol consumption

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 examination, and group 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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:

- Current existing psychiatric disorder other than alcohol or nicotine dependence.

- Elevated liver enzymes greater than four times the upper limit of the normal range or

elevated direct bilirubin.

- Serious medical co-morbidity requiring medical intervention or close supervision or

any condition which can interfere with the receipt of ondansetron.

- Severe or life-threatening adverse reactions to medications either in the past or

during this clinical trial.

- Females who are pregnant, nursing, or not using an acceptable form of contraception

at any time during the study.

- Received inpatient or outpatient treatment for alcohol dependence within the last 30

days.

- Members of the same household.

- Treated with medications having a potential effect on alcohol consumption or mood.

- Urine must be free of opiates, cocaine, amphetamines, barbiturates, benzodiazepines,

and other prescription and non-prescription drugs.

- Severe alcohol withdrawal symptoms which require inpatient treatment.

- Mandatory participation in an alcohol treatment program.

- Pyrexia of unknown origin.

- Past or current history or seizures.

- Past or current history of recurrent kidney stones.

- History of glaucoma.

Mindy Borszich, BA, Phone: (434) 243-0549, Email: uvacare@virginia.edu

University of Virginia Center for Addiction Research and Education, Charlottesville, Virginia 22911, United States; Recruiting
Mindy Borszich, BA, Phone: 434-243-0549, Email: uvacare@virginia.edu
Eva Jenkins-Mendoza, BS, Phone: (434)243-0562, Email: uvacare@virginia.edu
Bankole Johnson, M.D., Principal Investigator
Nassima Ait-Daoud, M.D., Sub-Investigator

UVA CARE Richmond, Richmond, Virginia 23294, United States; Recruiting
Johnson Bankole, MD, Principal Investigator
Nassima Ait-Daoud,, MD, Sub-Investigator

Related publications:

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. Review.

Starting date: March 2005
Ending date: August 2010
Last updated: February 3, 2009