Effects of Levetiracetam (Keppra) on Alcohol Consumption

The investigators propose a 42-day, double-blind, placebo-controlled crossover study in light to moderate and heavy alcohol users who are social drinkers.

The specific aims are to:

• Determine if levetiracetam alters daily alcohol consumption by comparing the mean drinks consumed per day during levetiracetam administration compared with the mean drinks per day consumed during placebo administration.
• Obtain blood that will be banked for future genetic analysis of polymorphisms in genes that may predict the level of response to alcohol or effects of levetiracetam on alcohol consumption.
• Test whether the AccuswayTM platform can detect changes in body sway in light to moderate or heavy social drinkers and in subjects taking levetiracetam versus placebo.

Inclusion criteria

• Healthy adults who are social drinkers 21 and 50 years of age.
• Moderate to heavy social drinkers (women=7-21 drinks/week, men=7-25 drinks/week).
• Body Mass Index (BMI)>18 and <30.
• If female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device [IUD], hormonal birth control, or double barrier method [male condom, female condom, or diaphragm plus a spermicidal agent such as contraceptive foam, jelly or cream]).
• Able and willing to provide written informed consent.
• Able to understand and follow the instructions of the investigator, and understand all rating scales.
• Have a negative urine drug screen at all visits, with the exception of cannabinoids.

Exclusion criteria

• Positive urine drug screen, except cannabinoids. Occasional cannabinoid use is allowed, however daily use, dependence, or if considered more than a casual user by study physician, subject will be excluded.
• Use of cocaine, amphetamines or other stimulants, hallucinogens, ecstasy or other psychoactive drugs, greater than 10 times in the last 24 months or at anytime in the past 60 days.
• Lifetime use of PCP or ketamine greater than 10 times, or at any time in the last 24 months.
• History of abusing inhalants (such as glue, toluene or other volatile substances).
• Current or past dependence on, or addiction to any psychoactive drug (except nicotine or caffeine) including alcohol, as determined by the study physician's assessment.
• Current or prior enrollment in an alcohol or other drug treatment program, or current legal problems relating to alcohol or other drug use, including awaiting trial or supervision by a parole or probation officer.
• Binge drinking more than three times per week (binge defined as >5 standard drinks in one session).
• Alcohol consumption >21 drinks/week for women and >25 drinks/week for men.
• Currently trying to quit alcohol and/or recreational drug use.
• Positive for lifetime abnormal opioid use or prescription drug abuse.
• Clinically significant medical or psychiatric illness (including anxiety or panic disorders) as determined by screening blood tests, medical history, and physical exam performed or reviewed by the study physician.
• Bilirubin more than 2 times the normal upper limit.
• AST (SGOT), ALT (SGPT), or alkaline phosphatase more than 2 times the normal upper limit.
• Body Mass Index >30 or <18
• Pregnancy or a woman of child bearing potential not currently using an adequate means of contraception.
• Currently taking any medication other than over-the-counter nonsteroidal anti-inflammatories, acetaminophen, inhaled asthma therapy, contraceptives, nicotine patches, and over-the-counter non-sedating antihistamines.NSAIDs, acetaminophen, or any other OTC (including herbal) medication (unless cleared by study physician).
• BAC level greater than 0.02% at the beginning of visits 1, 7, or 8 (within margin of error for detection).
• Estimated creatinine clearance < 50 ml/min.
• Chronic pain condition requiring regular physician visits and treatment under a physician's supervision.
• Neurological dysfunction or psychiatric disorder severe enough to interfere with assessment of outcome measures as defined above.
• Allergy to levetiracetam.
• Significant cardiac pathology or abnormal initial EKG with QT/QTc interval prolongation > 480 m secs at baseline.
• Has received an investigational drug within 30 days prior to Study Visit 2 (after screening visit).
• Subjects who are unable to read or speak English.
• Those, in the opinion of the investigator, who are considered unable to adhere to scheduled appointments, unlikely to comply with the study protocol, or who are unsuitable for any other reason.