Effects of Ghrelin on Alcohol Cue Reactivity and Craving

Inclusion criteria

• Understanding that this is not a treatment study.
• Breath alcohol concentration (BAC) equal to 0.00 when the participants sign the informed consent document.
• Age between 18 and 70 years old (inclusive).
• Female participants must be postmenopausal for at least one year, surgically sterile, or practicing an effective method of birth control before entry and throughout the study; have a negative urine pregnancy test at screening and cue-reactivity (CR) visits.
• Diagnosis of Alcohol dependence using Module E of the structured clinical interview for the Diagnostic and Statistical Manual of Mental Disorders - Text Revised (DSM-IV-TR).
• Participants must meet criteria for heavy drinking, defined as averaging ≥4 drinks/day for women and ≥5 drinks/day for men during a consecutive 30-day period within the 90 days prior to baseline evaluation
• Good health as confirmed by medical history, physical examination, electrocardiogram (ECG), laboratory tests and vital signs.
• Participant must be willing to receive an I.V. line.

Exclusion criteria

• Individuals expressing interest in treatment for alcoholism.
• Females who are of child bearing potential and not practicing effective birth control.
• Current (last 12 months) diagnosis of dependence on any psychoactive substance other than alcohol and nicotine (according to the DSM-IV-TR)
• DSM-IV-TR Axis I criteria for a lifetime diagnosis of schizophrenia, bipolar disorder, or other psychoses; an active illness within the past 6 months that meet the DSM-IV-TR criteria for a diagnosis of Major Depressive Disorder or Anxiety Disorder; in the investigators' opinion, moderate to severe risk of suicide (e.g. active plan, or attempt in last 6 months).
• History of hospitalization for alcohol intoxication delirium, alcohol withdrawal delirium or seizure.
• Clinical Institute Withdrawal Assessment for Alcohol revised (CIWA-Ar) ≥ 10, at any assessment.
• Positive urine drug screen at baseline for any illegal substance other than marijuana (a urine drug screen may be repeated once during the screening period).
• Subjects who have received any behavioral and/or pharmacological treatment for alcoholism within the past 30 days.
• Current use of psychotropic medications that cannot be discontinued.
• Clinically significant medical abnormalities [e.g., alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >300% the upper limit of normal].
• Significant medical conditions, such as cancer, liver cirrhosis, heart chronic failure, chronic kidney failure, chronic intestinal diseases (e.g., Crohn's disease), chronic neurological disorders (e.g., tardive dyskinesia, epilepsy, Parkinson's disease), diabetes, obesity [Body Mass Index(BMI) ≥ 30 kg/m2].
• Participants with a history of hypotension clinically significant (e.g.: history of fainting and/or syncopal attacks).
• No history of adverse reactions or hypersensitivity to ghrelin i.v. nor history of adverse reactions to needle puncture.