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Ondansetron Treatment for Alcoholism

Primary Purpose

Alcoholism

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ondansetron (Zofran)
Sponsored by
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meet criteria for alcohol dependence. Subjects with early onset alcoholism must also have a diagnosis of antisocial personality disorder. Understand the requirements of the study and be able to complete the questionnaires and rating scales. Exclusion Criteria: Current diagnosis of substance dependence or self-report of having used narcotics (opiates, cocaine, amphetamine-like substances, and hallucinogens) in the 30 day period prior to study. Positive urine drug screen test for narcotics, barbiturates, or benzodiazepines. Receiving current psychotropic medications. Current history of other psychiatric disorders excluding nicotine dependence. Hepatocellular disease. Pregnant females.

Sites / Locations

  • Substance Abuse Research Center, University of Texas Health Science Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00000443
Brief Title
Ondansetron Treatment for Alcoholism
Official Title
Pharmacological Treatment for Alcoholism
Study Type
Interventional

2. Study Status

Record Verification Date
August 2002
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to: a) evaluate the effectiveness of ondansetron (Zofran) in the treatment of alcohol dependent patients; b) investigate whether early versus late onset alcoholism predicts treatment outcome; and c) determine whether the early and late onset groups respond differently to treatment. Individuals will be "typed" into early onset and late onset alcoholism groups. Individuals will be randomly assigned to a 12-week outpatient treatment program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ondansetron (Zofran)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet criteria for alcohol dependence. Subjects with early onset alcoholism must also have a diagnosis of antisocial personality disorder. Understand the requirements of the study and be able to complete the questionnaires and rating scales. Exclusion Criteria: Current diagnosis of substance dependence or self-report of having used narcotics (opiates, cocaine, amphetamine-like substances, and hallucinogens) in the 30 day period prior to study. Positive urine drug screen test for narcotics, barbiturates, or benzodiazepines. Receiving current psychotropic medications. Current history of other psychiatric disorders excluding nicotine dependence. Hepatocellular disease. Pregnant females.
Facility Information:
Facility Name
Substance Abuse Research Center, University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Ondansetron Treatment for Alcoholism

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