Please select the eligibility criteria that correspond to the clinical trial below.
Title: Placebo-Controlled Crossover Trial of Levetiracetam on Ethanol Intake
Brief Summary: The overall goals of this study are to (1) expand knowledge about interactions of levetiracetam with alcohol by assessing the effects of levetiracetam compared to placebo in moderate and heavy social alcohol users and (2) to test the AccuswayTM platform as a tool to measure postural control (which has been used as a marker of intoxication) and the effects of levetiracetam on postural control.


Options:
A: Inclusion Criteria:

* Meet criteria for primary alcohol dependence including loss of control of drinking
* No more than one previous inpatient medical detoxification
* Consumes on average 5 standard drinks for men and 4 standard drinks for women
* Able to maintain sobriety for 4 days (with or without detox medications).
* Able to read and understand questionnaires and Informed Consent
* Lives within 50 miles of the study site

Exclusion Criteria:

* Currently meets DSM-IV criteria for any other psychoactive substance dependency disorder except nicotine dependence
* Ever abused opiates
* Any psychoactive substance abuse, except marijuana and nicotine within the last 30 days as evidenced by subject report, collateral report, or urine drug screen.
* Meets DSM-IV criteria for current Axis I disorder of major depression, panic disorder, obsessive-compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, dissociative disorder or eating disorder, schizophrenia, or any other psychotic disorder or organic mental disorder.
* Has current suicidal or homicidal ideation
* Need for maintenance or acute treatment with any psychoactive medication including antiseizure medications.
* Current use of disulfiram.
* Clinically significant medical problems, such as cardiovascular, renal, GI or endocrine problem that would impair participation or limit medication ingestion.
* Hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at least 3.0 times normal at screening and/or after 5 days of abstinence.
* Sexually active females of child bearing potential who are pregnant (by urine HCG), nursing or who are not using a reliable form of birth control.
* Has current charges pending for a violent crime (not including DUI related offenses).
* Does not have a stable living situation and a reliable source of collateral reporting.
* Has taken an opiate antagonist drug in the last month.
* Has taken gabapentin in the last month or has experienced adverse effects from it at any time in the past.
B: Inclusion criteria

The following inclusion criteria are to be met:

1. Male and female outpatients \> 18 years of age.
2. Participants will have a current DSM-IV diagnosis of alcohol dependence.
3. Participants will have signed a witnessed informed consent.
4. Participants must have been drinking a minimum of \> 14 drinks (females) or \> 21 drinks (males) on average per week over a consecutive 30-day period in the 90-day period prior to initiation of abstinence, and have two or more days of heavy drinking (defined as 4 drinks for females and 5 drinks for males) in the 90-day period prior to initiation of abstinence.
5. Participants must have had a minimum of 4 consecutive days (96 hours) of abstinence and have a CIWA \< 8 prior to randomization.
6. Participants can be abstinent for a maximum of 21 days prior to randomization.
7. Participants will have no more than 21 consecutive days of planned absence during the 16 week active treatment period.
8. Participants who are able to identify at least one "locator" person to assist in tracking the participant for follow-up assessment.
9. Participants who are able to speak and understand English.

Exclusion criteria

The following exclusion criteria rule out participants:

1. Participants who meet current DSM-IV criteria for bipolar disorder, schizophrenia, bulimia/anorexia, dementia, or a psychological disorder requiring medication.
2. Participants requiring concomitant therapy with any medications that pose safety issues (see Appendix B).
3. Participants with a current diagnosis of dependence on any drug except for nicotine, cannabis, and alcohol, or habitual caffeine use. If there is a positive urine screen the participant can be retested after the (metabolic) interval appropriate to that drug. If the second urine drug screen is positive the person is excluded.
4. Participants who meet DSM-IV criteria for opiate dependence or abuse within the past 6 months, chronic treatment with any opiate-containing medications during the previous month, or urine positive for opioids.
5. Participants who have significant medical disorders that will increase the potential risk of study treatment or interfere with study participation, and participants with sensitivity to study medications or related drugs as evidenced by adverse drug experience, especially with opiate-containing analgesics, opioid antagonists, or acamprosate.
6. Participants with abnormal AST or ALT (more than 3 times the upper limit of the normal range(ULN)) or elevated bilirubin (more than 10% above the ULN). Tests may be repeated if initial results are out of range.
7. Participants who are pregnant or nursing infant(s), and women of childbearing potential not using a contraceptive method judged by the investigator to be effective.
8. Participants who intend to engage in additional formal treatment for alcohol-related problems, or who intend to continue in current treatment for alcohol-related problems during the active treatment period. Self-help treatments are not considered formal treatment.
9. Participants who have had more than seven days of inpatient treatment for substance use disorders in the 30 days previous to randomization.
10. Participants who have prior use of study medication(s) in the last 30 days.

Any question concerning the interpretation of or application of the inclusion/exclusion criteria will be referred to the medical expert at the Coordinating Center. If he is unavailable, the question will be referred to the Chairperson of the Treatment Subcommittee.
C: Inclusion Criteria:

1. Healthy adults who are social drinkers 21 and 50 years of age.
2. Moderate to heavy social drinkers (women=7-21 drinks/week, men=7-25 drinks/week).
3. Body Mass Index (BMI)\>18 and \<30.
4. 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 \[male condom, female condom, or diaphragm plus a spermicidal agent such as contraceptive foam, jelly or cream\]).
5. Able and willing to provide written informed consent.
6. Able to understand and follow the instructions of the investigator, and understand all rating scales.
7. Have a negative urine drug screen at all visits, with the exception of cannabinoids.

Exclusion Criteria:

1. 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.
2. 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.
3. Lifetime use of PCP or ketamine greater than 10 times, or at any time in the last 24 months.
4. History of abusing inhalants (such as glue, toluene or other volatile substances).
5. 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.
6. 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.
7. Binge drinking more than three times per week (binge defined as \>5 standard drinks in one session).
8. Alcohol consumption \>21 drinks/week for women and \>25 drinks/week for men.
9. Currently trying to quit alcohol and/or recreational drug use.
10. Positive for lifetime abnormal opioid use or prescription drug abuse.
11. 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.
12. Bilirubin more than 2 times the normal upper limit.
13. AST (SGOT), ALT (SGPT), or alkaline phosphatase more than 2 times the normal upper limit.
14. Body Mass Index \>30 or \<18
15. Pregnancy or a woman of child bearing potential not currently using an adequate means of contraception.
16. 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).
17. BAC level greater than 0.02% at the beginning of visits 1, 7, or 8 (within margin of error for detection).
18. Estimated creatinine clearance \< 50 ml/min.
19. Chronic pain condition requiring regular physician visits and treatment under a physician's supervision.
20. Neurological dysfunction or psychiatric disorder severe enough to interfere with assessment of outcome measures as defined above.
21. Allergy to levetiracetam.
22. Significant cardiac pathology or abnormal initial EKG with QT/QTc interval prolongation \> 480 m secs at baseline.
23. Has received an investigational drug within 30 days prior to Study Visit 2 (after screening visit).
24. Subjects who are unable to read or speak English.
25. 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.
D: Inclusion Criteria:

* Have a current diagnosis of alcohol dependence
* drink an average of 28 or more standard drinking units/week for women or 35 or more standard drinking units/week for men
* have a desire to stop drinking completely or to reduce alcohol consumption with the possible long-term goal of abstinence
* have a body mass index of 18 or more
* sexually active women capable of having children must be using an acceptable method of birth control
* must be in generally good health.

Exclusion Criteria:

* No current or recent (within 6 months) diagnosis of other substance abuse or dependence
* no inpatient or outpatient counseling for alcohol dependence other than Alcoholics Anonymous within 4 weeks
* not more than 4 past failed inpatient treatments attempts for alcohol dependence
* no other psychiatric disorder that requires treatment with medication or therapy
* no current probation or parole requirement or legally mandated requirement to participate in an alcohol treatment program.

Answer: C