NCT00000443

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 1999

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2000

Completed
Last Updated

June 24, 2005

Status Verified

August 1, 2002

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Alcoholism

Interventions

ondansetron (Zofran)DRUG

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Substance Abuse Research Center, University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

November 3, 1999

Study Completion

April 1, 2000

Last Updated

June 24, 2005

Record last verified: 2002-08

Locations

US(1)