Ghrelin for Alcohol Use in Non-Treatment-Seeking Heavy Drinkers

• INCLUSION CRITERIA

Male and female participants between 21-60 years of age.

Good health as determined by medical history, physical exam, ECG and lab tests.

Creatinine greater than or equal to 2 mg/dl.

Female must have a negative urine pregnancy (hCG) test at the start of each study session. Females of childbearing potential must agree to use a reliable method of birth control during the study. Reliable methods of birth control include oral contraceptives or Norplant(Registered Trademark); barrier methods such as diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices; a partner with a vasectomy; or abstinence from intercourse.

Participants must drink alcohol regularly at a heavy level, on average greater than 20 drinks per week for men, and greater than 15 drinks per week for women, and not be seeking help for alcohol-related problems.

Participant must be willing to receive two IV lines.

EXCLUSION CRITERIA

Current or prior history of any clinically significant disease, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders.

Specific exclusion criteria related to the administration of ghrelin, are chronic inflammatory diseases (e.g., Crohn's disease, ulcerative colitis, celiac disease diabetes, obesity (BMI >= 30 kg/m2), high triglycerides level (> 350 mg/dL), history of clinically significant hypotension (e.g.: history of fainting and/or syncopal attacks).

Positive hepatitis or HIV test at screening.

Current history of Axis-I psychiatric illness.

Current or lifetime diagnosis of substance dependence.

Currently seeking treatment for alcohol use disorder.

History of significant withdrawal symptoms or presence of clinically significant withdrawal symptoms (Clinical Institute Withdrawal Assessment (CIWA) score > 8) at screening.

Non-drinkers (alcohol-na ve individuals or current abstainers) or no experience drinking 5 or more drinks on one occasion.

Positive result on urine drug screen.

Pregnancy or intention to become pregnant for women. Female participants will undergo a urine beta-hCG test to ensure they are not pregnant.

Use of prescription or OTC medications known to interact with alcohol within 2 weeks of the study. These include, but may not be limited to: isosorbide, nitroglycerine, benzodiazepines, warfarin, anti-depressants such as amitriptyline, clomipramine and nefazodone, anti-diabetes medications such as glyburide, metformin and tolbutamide, H2-antagonists for heartburn such as cimetidine and ranitidine, muscle relaxants, anti-epileptics including phenytoin and Phenobarbital codeine, and narcotics including darvocet, percocet and hydrocodone. Drugs known to inhibit or induce enzymes that metabolize alcohol should not be used for 4 weeks prior to the study. These include chlorzoxazone, isoniazid, metronidazole and disulfiram. Cough-and-cold preparations, which contain antihistamines, pain medicines and anti-inflammatories such as aspirin, ibuprofen, acetaminophen, celecoxib and naproxen, should be withheld for at least 72 hours prior to each study session.

Current or prior history of alcohol-induced flushing reactions.

Contraindications for MRI scanning, including metal in body that are contraindicated for MRI (such as implants, pacemaker, prostheses, shrapnel, irremovable piercings), left-handedness, and claustrophobia.