Alcohol Dependency Study: Combining Medication Treatment for Alcoholism

March 14, 2013 updated by: Bankole Johnson

Combining Medications Treatment for Alcoholism

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Recruiting
        • University of Virginia Center for Addiction Research and Education
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bankole Johnson, DSc, MD, PhD
        • Sub-Investigator:
          • Nassima Ait-Daoud Tiouririne, MD
      • Richmond, Virginia, United States, 23294
        • Recruiting
        • University of Virginia Center for Addiction Research and Education
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bankole Johnson, DSc, MD, PhD
        • Sub-Investigator:
          • Nassima Ait-Daoud Tiouririne, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ondansetron
Ondansetron + cognitive behavioral therapy
Drug: ondansetron + cognitive behavioral therapy
ondansetron (4 mcg/kg b.i.d)
Other Names:
  • Zofran
Experimental: Topiramate
Topiramate + cognitive behavioral therapy
Drug: topiramate + cognitive behavioral therapy
topiramate (up to 300 mg/day)
Other Names:
  • Topamax
Placebo Comparator: Placebo
Placebo + cognitive behavioral therapy
Drug: Placebo + cognitive behavioral therapy
placebo
Other Names:
  • sugar pill
Experimental: Ondansetron + Topiramate
Ondansetron + Topiramate + cognitive behavioral therapy
Drug: ondansetron + topiramate + cognitive behavioral therapy
ondansetron (4 mcg/kg b.i.d) + topiramate (up to 300 mg/day)
Other Names:
  • zofran, topamax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption
Time Frame: Throughout the study
Drinks per drinking day, Drinks per day, Percent Days Abstinent, BAC, CDT, GGT
Throughout the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors
Time Frame: Throughout the study
Pill Count, Q-LES-Q, SFQ, AASE, ADBS, OCDS, CIWA-Ar, CGI, TCI, MAC, AOQ, FHAM
Throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bankole Johnson

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Bankole Johnson, DSc, MD, PhD, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

September 11, 2000

First Submitted That Met QC Criteria

September 11, 2000

First Posted (Estimate)

September 12, 2000

Study Record Updates

Last Update Posted (Estimate)

March 15, 2013

Last Update Submitted That Met QC Criteria

March 14, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAAAJOH1052207A1
  • R01AA013964 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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