Intervention: Carisbamate
Trial phase: Phase 1 | Phase 2
ATC code: N03AX19
SMILES: NC(=O)OC[C@@H](O)c1ccccc1Cl
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Participants will receive carisbamate 600mg qd from days 2- 4.

Carisbamate: 600mg Orally on days 2-4
Eligibility criteria:
Inclusion Criteria:

Be an English-speaking volunteer who is not seeking treatment at the time of the study
Be between 18-55 years of age
Meet DSM-IV TR criteria for alcohol abuse; participants may or may not meet criteria for nicotine dependence. Nicotine dependence is allowed but not required because most alcohol users smoke cigarettes.
Have a self-reported history of using alcohol.
Have vital signs as follows: resting pulse must be < 90 bpm and the blood pressure must be < 150 mmHg systolic and < 90 mmHg diastolic.

Have hematology and chemistry laboratory tests that are within normal (+/- 10%) limits with the following exceptions:

liver function tests (total bilirubin, ALT, AST, and alkaline phosphatase) < 3 x the upper limit of normal, and b) kidney function tests (creatinine and BUN) within normal limits
Have a baseline EKG that demonstrates clinically normal sinus rhythm, clinically normal conduction, and no clinically significant arrhythmias
Have a medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the admitting physician and the principal investigator.

Exclusion Criteria:

Meet DSM IV TR criteria for dependence on drugs other than alcohol or nicotine.
Have any history or evidence suggestive of seizure disorder or brain injury
Have any previous medically adverse reaction to alcohol, including loss of consciousness, chest pain, or epileptic seizure

Have neurological or psychiatric disorders, such as:

psychosis, bipolar illness or major depression as assessed by SCID
organic brain disease or dementia assessed by clinical interview
history of any psychiatric disorder which would require ongoing treatment or which would make study compliance difficult
history of suicide attempts within the past year and/or current suicidal ideation/plan
Have evidence of clinically significant heart disease or hypertension, as determined by the PI
Have evidence of untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease
Have symptomatic HIV or are taking antiretroviral medication
Be pregnant or nursing. Other females must either be unable to conceive (i.e., surgically sterilized, sterile, or post-menopausal) or be using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device, condoms, or spermicide). All females must provide negative pregnancy urine tests before study entry, upon hospital admission, and at the end of study participation
Have any other illness, condition, or use of psychotropic medications, which in the opinion of the PI and/or the admitting physician would preclude safe and/or successful completion of the study.
Currently seeking help for alcohol dependence.
Subjects with or prone to clinically significant alcohol withdrawal.
More than thirty days of abstinence from alcohol in the ninety days prior to enrollment.
A history of major alcohol-related medical complications requiring hospitalization (i.e. pancreatitis).
Contraindication(s) to take the study medication such as renal or hepatic impairment, nephrolithiasis, congenital metabolic disorders or history of seizures. Moderate-to-severe renal impairment defined as creatinine clearance less than 30 mL/min.
Use of inhibitors/substrates for renal cationic transporters, or medications contraindicated with ethanol.
A history of violence or aggression, assessed as part of the clinical interview at screening visit.