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.
This is a double-blind placebo-controlled study. Eligible subjects will be randomized to
ondansetron (4 ug/kg) and olanzapine (9, 18, 36 ug/kg) vs placebo. All subjects will
participate in a 9 week regimen of weekly BBCET and outpatient medication treatment.
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- 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
- Willing to participate in behavioral treatments for alcoholism
- Answer an advertisement in the newspaper/radio/television, and express a wish to stop
- 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
- Any current axis I DSM-IV psychiatric disorder other than alcohol or nicotine
dependence that warrants treatment or would preclude safe participation in the
- Severe alcohol withdrawal symptoms that, in the physician's opinion, require inpatient
- 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
- 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