Ondansetron With Olanzapine for the Treatment of Alcohol Dependence: A Preliminary Clinical Trial

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study would like to test whether the combination of ondansetron and olanzapine will be superior to placebo at decreasing self-reported heavy drinking among early onset alcoholics.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Treatments: Ethanol; Olanzapine; Ondansetron

Criteria

Inclusion Criteria:

• Males and females who have given written informed consent

• Aged 18 years and above and weighing ≥40 kg and ≤140 kg

• Drinking on average ≥21 and ≥28 drinks/week for women and men, respectively, in the 7-day period prior to enrollment

• DSM-IV-R diagnosis of alcohol dependence

• Good physical health as determined by a complete physical examination, electrocardiogram (EKG) within normal limits and laboratory screening tests within acceptable range

• Negative pregnancy test at intake.

• Literate in English and able to read, understand, and complete the rating scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments

• Willing to participate in behavioral treatments for alcoholism

• Answer an advertisement in the newspaper/radio/television, and express a wish to stop drinking

• Provide evidence of stable residence in the last month prior to enrollment in the study, and have no plans to move in the next three months

Exclusion Criteria:

• Any current axis I DSM-IV psychiatric disorder other than alcohol or nicotine dependence that warrants treatment or would preclude safe participation in the protocol

• Severe alcohol withdrawal symptoms that, in the physician's opinion, require inpatient treatment

• Serious medical comorbidity requiring medical intervention or close supervision, or any condition that can interfere with the receipt of ondansetron or olanzapine

• Severe or life-threatening adverse reactions to the ondansetron or olanzapine medications in the past or during this clinical trial

• Female subjects 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

• Significant medical illness (including hypertension) as determined by history and/or complete physical examination.

• Gross neurological disease

• Mental retardation

• Pyrexia of unknown origin

• Diagnosis or suspicion of Alzheimer's disease

• Clinically significant abnormalities on the EKG that will preclude safe participation

• Recent (last 3 months) history of ischemic heart disease or myocardial infarction.

• Current infective hepatitis as evidenced by clinical manifestations. If hepatitis is suspected, a hepatitis antibody/antigen screen will be done.

• Participation in a clinical study within the last 30 days

• Elevation of liver enzymes

• History of any severe or life-threatening reaction to olanzapine or ondansetron

• Past or current history of seizures disorder

• Past or current history of diabetes

• Being treated with any medication with potential for clinically significant interactions with alcohol or olanzapine and/or ondansetron. These include:, serotonin antagonists (e.g., ritanserin or buspirone), dopamine antagonists (e.g., haloperidol), or compounds with actions similar to disulfiram (Antabuse®).

• Pending imprisonment