The Effects of Levetiracetam on Alcohol Dependent Subjects

NCT00325182 | Completed Phase 4

• 1 other identifier: H-23008
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcoholism

Keywords

Alcoholism

Outcome Measures

Primary Outcomes (1)

• Change in mean number of drinks

  The primary outcome of this study will be determined by comparing the mean drinks consumed per day at baseline (the month prior to the screening session) compared with the mean drinks per day consumed during week 11 of the treatment period.

  Baseline and at 11 weeks

Secondary Outcomes (2)

• Heavy drinks per drinking day

  At 13 weeks and last value carries forward approaches

• OCDS scores, MOS-Sleep Scores, and POMS scores.

  At 13 weeks and last value carries forward approaches

Study Arms (2)

Intervention: Levetiracetam

EXPERIMENTAL

Levetiracetam dose schedule Days 1-4 250 mg bid Days 5- 19 500 mg bid Days 20 -70 1000 mg bid Days 71-78 500 mg bid Days 79-85 250 mg bid Days 86-91

Drug: Levetiracetam

Historical controls

PLACEBO COMPARATOR

Historical controls from COMBINE study who receive a placebo

Other: Historical controls

Interventions

Levetiracetam DRUG

Also known as: Keppra

Intervention: Levetiracetam

Historical controls OTHER

Historical controls

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston University: lead
• UCB Pharma: collaborator

Study Sites (1)

Boston University Dept of Psychiatry Clinical Studies Unit

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ofra Sarid-Segal, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2006
• First Posted: May 12, 2006
• Study Start: January 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: October 1, 2009
• Last Updated: March 15, 2017

Record last verified: 2007-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)