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Ondansetron Treatment for Alcoholism

Pharmacological Treatment for Alcoholism

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00000443
Enrollment
Unknown
Registered
1999-11-03
Start date
Unknown
Completion date
2000-04-30
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholism

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.

Interventions

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026