Ondansetron Treatment for Alcoholism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Completion Date

2000-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Alcoholism

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ondansetron (Zofran)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Substance Abuse Research Center, University of Texas Health Science Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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NIAAAJOH10522

Identifier Type: -

Identifier Source: org_study_id