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Completed

NCT Number: NCT00000443

Ondansetron Treatment for Alcoholism

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.

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Key information

Conditions

Alcoholism Alcohol-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Substance Abuse Research Center, University of Texas Health Science Center

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ondansetron (Zofran)

Drug

Sponsors and collaborators

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Nih

Registry information

Official study title

Pharmacological Treatment for Alcoholism

Important dates

Study completion
2000
First posted
Nov 3, 1999
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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