Recruiting
Phase 2

Medication Treatment

Sponsor:

Bankole Johnson

Code:

NCT00006205

Conditions

Alcoholism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ondansetron + cognitive behavioral therapy

topiramate + cognitive behavioral therapy

Placebo + cognitive behavioral therapy

ondansetron + topiramate + cognitive behavioral therapy

Study Details

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.

Conditions

Alcoholism

Study ID

NCT00006205

Start date

Mar, 2005

Status verified date

Mar, 2013

Completion date

Dec, 2013

Anticipated

Primary completion date

Jun, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

320 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ondansetron

Ondansetron + cognitive behavioral therapy

experimental: Topiramate

Topiramate + cognitive behavioral therapy

placebo comparator: Placebo

Placebo + cognitive behavioral therapy

experimental: Ondansetron + Topiramate

Ondansetron + Topiramate + cognitive behavioral therapy

Interventions

ondansetron + cognitive behavioral therapy

ondansetron (4 mcg/kg b.i.d)

topiramate + cognitive behavioral therapy

topiramate (up to 300 mg/day)

Placebo + cognitive behavioral therapy

placebo

ondansetron + topiramate + cognitive behavioral therapy

ondansetron (4 mcg/kg b.i.d) + topiramate (up to 300 mg/day)

Primary outcome measure

  • Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption [ Time Frame: Throughout the study ]

Central Contacts and Locations

Central contacts

Mindy Borszich

1-888-882-2345mcb3x@virginia.edu

Eva Jenkins-Mendoza

(434) 243-0562emj9c@virginia.edu

Locations

University of Virginia Center for Addiction Research and Education

Recruiting

Charlottesville, Virginia, United States, 22911

Contacts

Mindy Borszich

888-882-2345mcb3x@virginia.edu

Eva Jenkins-Mendoza

(434)243-0562emj9c@virginia.edu

Principal Investigator:

Bankole Johnson, DSc, MD, PhD

University of Virginia Center for Addiction Research and Education

Recruiting

Richmond, Virginia, United States, 23294

Contacts

Mindy Borszich

888-882-2345mcb3x@virginia.edu

Eva Jenkins-Mendoza

(434)243-0562emj9c@virginia.edu

Principal Investigator:

Bankole Johnson, DSc, MD, PhD

More Information

Sponsor

Bankole Johnson

Last update posted

Mar 15, 2013

Last verified

Mar, 2013

Keywords

  • alcoholism
  • alcohol addiction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bankole Johnson on 2013-03-15.