Ondansetron Treatment for Alcoholism

Alcoholism Clinical Trial

Official title:

Pharmacological Treatment for Alcoholism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000443
• Other study ID #: NIAAAJOH10522
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005
• Est. completion date: April 2000

Study information

• Verified date: August 2002
• Source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• ondansetron (Zofran)

Locations

Country	Name	City	State
United States	Substance Abuse Research Center, University of Texas Health Science Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States,