Combined Pharmacotherapies for Alcoholism (Naltrexone/Ondansetron)
NCT ID: NCT00027079
Last Updated: 2007-12-10
Study Results
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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COMPLETED
PHASE2
360 participants
INTERVENTIONAL
2001-09-30
2004-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Interventions
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ondansetron (Zofran)
naltrexone (ReVia)
Cognitive Behavioral Therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
* Current treatment with any medications having a potential effect on alcohol consumption and related behaviors or mood.
* Urine must be free of opiates, cocaine, amphetamines, barbiturates, benzodiazepines, prescription and non-prescription drugs.
* Pyrexia of unknown origin.
18 Years
65 Years
ALL
No
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Locations
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University of Texas Health Science Center
San Antonio, Texas, United States
Countries
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Other Identifiers
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NIAAAJOH12964
Identifier Type: -
Identifier Source: org_study_id