The Effects of Levetiracetam on Alcohol Dependent Subjects

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will attempt to examine whether Levetiracetam (Keppra (TM)) can help people with alcohol dependence cut down on their alcohol consumption. In addition, the investigation will assess the effectiveness of Keppra on reducing withdrawal symptoms post alcohol cessation. Matched group of historical controls of alcohol dependent patients receiving placebo will be used for comparison.Based on the mechanism of action of Keppra we hypothesize that it may be effective in promoting abstinence and reducing drinking behavior in alcohol dependent patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boston University
• Collaborator: UCB Pharma
• Treatments: Etiracetam; Levetiracetam; Piracetam

Criteria

Inclusion Criteria:

• DSM IV TR Diagnosis of Alcohol Dependence

• Male or female age 21-60 years old

• Able to provide informed consent and comprehend study procedures

• Negative urine toxicological screen for narcotics, amphetamines, sedative hypnotics and cannabinoids. The test may be repeated within a week.

• Score of > 8 on Alcohol Use Disorder Identification Test during screening

• Must be suitable for outpatient management

• Express desire to stop drinking or reduce alcohol consumption with possible long-term goal of abstinence.

• Provide contact information for themselves or an alternate contact that the study staff will contact in case of missed appointment.

• Female subjects must be postmenopausal for at least one year, or practicing an effective method of birth control before entry and throughout the study

• Must be able to take oral medications, adhere to regimen and be willing to return for follow up visits

• Must have breath alcohol concentration of no more than 0.025% when signing the informed consent

Exclusion criteria:

• Dependent on or extensive abuse of drugs or substances other than ethanol, nicotine or caffeine

• DSM IV- TR diagnosis of any current Axis I diagnosis other than alcohol, nicotine or caffeine dependence that in the investigator's judgment might require intervention with either pharmacological or non-pharmacological therapy that might interfere with the course of the study

• Receiving inpatient or outpatient treatment for alcohol dependence (with the exception of AA or other self-help groups) within the 4 weeks prior to enrollment

• Subjects with a score of 10 or greater on the CIWA-Ar at visits one and two

• Currently being treated with disulfiram or naltrexone

• Currently being treated with any the following medications: a) Antipsychotic agent [b) Lithium Carbonate c) Anticonvulsant agent d) Hypnotics e) Antianxiety Agents f) Chronic opiate treatment with methadone, laam, buprenorphine; oxycodone, morphine, etc g) Stimulant treatment

• Subjects who are legally mandated to participate in alcohol treatment program

• Subjects who have had a suicide attempt or suicidal ideation within 30 days of the first visit

• Subjects with renal disease

• Subjects with AST and ALT >3 times the upper limit of the normal range during screening. Test may be repeated prior to enrollment. If repeat lab values are all within acceptable ranges subject may continue study participation.

• Major neurological disorder including seizures

• Subjects who are pregnant or lactating

• Subjects known to have clinically significant medical conditions, including, but not limited to: symptomatic CAD or PVD, malignancy or history of malignancy in the last 5 years, pulmonary disorders, endocrinological disorders

• Subjects with prior hypersensitivity to Keppra

• Subjects with history of medically complicated withdrawal from alcohol.

• Subjects who in the opinion of the investigator should not be enrolled in the study because of the precautions, warnings and contraindications outlined in the Keppra package insert

• Subjects with cardiac pacemaker or metal surgical implant