Safety and Pharmacodynamic Study of GET 73 in Alcohol Dependent

Inclusion Criteria:

- male or female subjects, between 21 and 65 years old (inclusive);

- participants must meet criteria for current Diagnostic and Statistical Manual
(DSM-IV)diagnosis of alcohol dependence,supported by the structured clinical interview
for DSM-IV Axis I Disorders Patient Edition;

- participants must meet criteria for heavy drinking, defined as averaging

- 4 drinks/day for women and ≥5 drinks/day for men during a 30-day period within
the 90 days prior to screening evaluation;

- participants must be in good health as confirmed by medical history, physical
examination, ECG, lab tests;

- females must be postmenopausal for at least one year or surgically sterile. Otherwise,
females will be excluded (even if they are using any kind of birth control). Proof
(medical records, certification from an medical doctor) of surgical sterility will be
required. Certification of postmenopausal for at least 1 year and postmenopausal
levels of FSH will also be required to be into the study;

- participants must be willing to take oral medication and adhere to the study
procedures;

- participants must give their consent to enter the study by signing the informed
consent form.

Exclusion Criteria:

- individuals seeking treatment for alcohol dependence;

- positive urine drug screen at baseline for positive drug screen for the following:
opioids, benzodiazepines, cocaine, methamphetamine or any other stimulants. A urine
drug screen may be repeated once and must test negative before randomization;

- individuals diagnosed with a current substance dependence, other than alcohol or
nicotine;

- meet DSM-IV Axis I criteria for a lifetime diagnosis of schizophrenia, bipolar
disorder, or other psychoses;

- Subjects taking any psychoactive medication that in the opinion of the subjects
primary care physician, cannot be discontinued at least 14 days prior to being
randomized;

- an active illness within the past 6 months of Visit 1 that meet the DSM-IV criteria
for a diagnosis of Major Depressive Disorder or Anxiety Disorder;

- subjects with a history of suicide attempts and/or at risk for suicide will be
excluded, based on the Structured Clinical Interview Disorders assessment and on the
Investigators' evaluation;

- clinically significant medical abnormalities (i.e., unstable hypertension, clinically
significant abnormal ECG, bilirubin > 150% of the upper normal limit, alanine
aminotransferase or aspartate aminotransferase elevations >300% the upper normal
limit, estimated creatinine clearance ≤ 60 dl/min);

- current use of any medications prescribed to reduce alcohol use e.g. naltrexone,
acamprosate, disulfiram or topiramate;

- concomitant use of cytochromeP450 2C19 substrates; assumption of cytochromeP450 2C19
and cytochromeP450 3A4 inhibitors or inducers in the 14 days before dosing;

- individuals with a reasonable expectation of being institutionalized during the course
of the trial;

- participants who have significant alcohol withdrawal symptoms, defined as a Clinical
Institute Withdrawal Assessment >10;

- history of seizures (e.g. epilepsy), including alcohol-related seizures;

- history of delirium tremens;

- subjects who have participated in any behavioral and/or pharmacological study within
the past 30 days;

- history of delirium tremens.