Alcohol Dependency Study: Combining Medication Treatment for Alcoholism

Bankole Johnson

Status and phase: Unknown; Phase 2

Conditions: Alcoholism

Treatments: Drug: ondansetron + cognitive behavioral therapy; Drug: topiramate + cognitive behavioral therapy; Drug: Placebo + cognitive behavioral therapy; Drug: ondansetron + topiramate + cognitive behavioral therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00006205

R01AA013964 (U.S. NIH Grant/Contract)

NIAAAJOH1052207A1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

---

320 participants in 4 patient groups, including a placebo group

Ondansetron

Experimental group

Description:

Ondansetron + cognitive behavioral therapy

Treatment:

Drug: ondansetron + cognitive behavioral therapy

Topiramate

Experimental group

Description:

Topiramate + cognitive behavioral therapy

Treatment:

Drug: topiramate + cognitive behavioral therapy

Placebo

Placebo Comparator group

Description:

Placebo + cognitive behavioral therapy

Treatment:

Drug: Placebo + cognitive behavioral therapy

Ondansetron + Topiramate

Experimental group

Description:

Ondansetron + Topiramate + cognitive behavioral therapy

Treatment:

Drug: ondansetron + topiramate + cognitive behavioral therapy