Combined Pharmacotherapies for Alcoholism (Naltrexone/Ondansetron)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)1 site in 1 country360 target enrollmentSeptember 2001

ConditionsAlcoholism

Drugsondansetron (Zofran)naltrexone (ReVia)

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Alcoholism
Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Enrollment: 360
Locations: 1
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will compare the effectiveness of ondansetron (Zofran) and naltrexone (ReVia) both alone and in combination in treating Early Onset Alcoholics versus Late Onset Alcoholics. All subjects will received standardized Cognitive Behavioral Therapy. Followup assessments will be completed at 1, 3, 6, and 9 months after treatment.

Registry

clinicaltrials.gov

Start Date

September 2001

End Date

August 2004

Last Updated

18 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Eligibility Criteria

Inclusion Criteria

•Current diagnosis of alcohol dependence.
•Provide a written informed consent.
•Must weigh within 30% of their ideal body weight.
•Patients must weigh at least 89 lbs. and no more than 342 lbs.
•Good physical health.
•Currently drinking 14 or more alcohol units per week for women and 21 or more alcohol units per week for men in the last 30 days.
•Provide evidence of stable residence in the last month prior to enrollment in the study.
•No plans to move in the nine months after entering the study.
•Literate in English and able to read, understand, and complete questionnaires and follow instructions.
•Willingness to participate in behavioral treatment for alcoholism.

Exclusion Criteria

•Current psychiatric disorder other than alcohol or nicotine dependence.
•Elevated liver enzymes or elevated bilirubin.
•Severe alcohol withdrawal symptoms which require treatment.
•Serious medical co-morbidity requiring medical intervention or close supervision.
•Severe or life-threatening adverse reactions to medications in the past or during this trial.
•Female patients who are pregnant, lactating, or not adhering to an acceptable form of contraception at any time during the study.
•Received inpatient or outpatient treatment for alcohol dependence within the last 30 days.
•Compelled to participate in an alcohol treatment program for alcohol dependence to maintain their liberty.
•Members of the same household.
•Tuberculosis.