Clinical trial NCT00382642 (phase 3, status: completed)
Conditions: alcohol dependence
ICD codes: F10.20, F10.24, F10.27, F10.280, F10.281, F10.282, F10.288
Drugs: ondansetron + cognitive behavioral therapy, placebo + cognitive behavioral therapy
SMILES: CN1C2=C(C3=CC=CC=C13)C(=O)C(CN1C=CN=C1C)CC2, 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.

          -  Ages 18 years and above and, must weigh at least 40 Kg and no more than 140 Kg

          -  Good physical health as determined by a complete physical examination, an EKG within
             normal limits, and laboratory screening tests within acceptable parameters.

          -  Audit score equal or more than 8

          -  Current DSM-IV diagnosis of alcohol dependence

          -  Currently drinking equal or more than 14 alcohol units/week for women and equal or
             more than 21 alcohol units/week for men in the last 30 days.

          -  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.

          -  The pregnancy test for females at intake must be negative. Additionally, women of
             childbearing potential must be using an acceptable form of contraception. These
             include: oral contraceptives, hormonal (levonorgestrel) or surgical implants, or
             barrier plus spermicide.

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

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

          -  Willingness to participate in behavioral treatments for alcoholism.

        Exclusion Criteria:

          -  Subjects who are legally mandated to participate in an alcohol treatment program.

          -  Any current axis I DSM IV psychiatric disorder other than alcohol or nicotine
             dependence

          -  Elevation of liver enzymes - (SGOT), serum glutamic pyruvic transaminase (SGPT), blood
             urea nitrogen (BUN), or lactate dehydrogenase (LDH) greater than four times the normal
             range, or clinically significant elevated direct bilirubin as deemed by the principal
             investigator.

          -  Severe alcohol withdrawal symptoms which in the physicians opinion requires inpatient
             treatment.

          -  Serious medical co-morbidity requiring medical intervention or close supervision, or
             any condition, which can interfere with the receipt of ondansetron.

          -  Severe or life-threatening adverse reactions to ondansetron or similar medication
             either in the past or during this clinical 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 (support groups such as AA are not exclusionary).

          -  Compelled to participate in an alcohol treatment program to maintain their liberty.

          -  Members of the same household.

          -  Treated with any medications having a potential effect on alcohol consumption and
             related behaviors, or mood. These include: opiate antagonist (e.g. naltrexone),
             glutamate antagonists (e.g., acamprosate), serotonin re-uptake inhibitors (e.g.
             fluoxetine), serotonin antagonists (e.g. ritanserin or buspirone), other
             antidepressants (e.g. tricyclic antidepressants or monoamine oxidase inhibitors),
             dopamine antagonists (e.g. haloperidol), calcium channel antagonists (e.g.
             isradipine), or compounds with actions similar to disulfiram (antabuse) or nicotine.

          -  Before double-blind randomization, urine must be free of opiates, cocaine,
             amphetamines, barbiturates, benzodiazepines, prescription and non-prescription drugs.