Clinical trial NCT00678457 (phase 2, status: completed)
Conditions: alcohol dependence
ICD codes: F10.20, F10.24, F10.27, F10.280, F10.281, F10.282, F10.288
Drugs: ondansetron, olanzapine, placebo
SMILES: CN1C2=C(C3=CC=CC=C13)C(=O)C(CN1C=CN=C1C)CC2, CNCCC(OC1=CC=C(C=C1)C(F)(F)F)C1=CC=CC=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility 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