Interdisciplinary Study of Two Novel Anticonvulsants in Alcoholism

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Alcoholism, Alcohol Dependence, Alcohol Abuse

In brief

This is a double-blind, placebo-controlled, parallel group design study with 4 treatment groups; levetiracetam, zonisamide, topiramate, and placebo control. Subjects will receive study medications for 14 weeks. Potential subjects will be initially screened for interest in study participation and alcohol consumption level to determine basic eligibility by telephone, or in person. Individuals who meet telephone screening criteria will be scheduled for a clinic appointment to obtain informed consent and conduct screening assessments. Subjects who report average drinks per day that are within the guidelines for safe levels of alcohol consumption (i.e. 2 drinks/ day males; 1 drink/day females-HHS standard) in the two weeks prior to screening will be excluded. Subjects meeting screening criteria will be scheduled for a second randomization visit. During this visit baseline assessments will be obtained. Eligible subjects will then be randomized to a treatment group and will be provided with the first week's study medications. The goal is to directly compare the efficacy and tolerability of two novel anticonvulsants, zonisamide and levetiracetam, with placebo, and using topiramate, which has extensive evidence supporting its efficacy in alcoholism, as a positive control group. We believe that this will be the first direct comparison of these agents in alcoholism, and the results will provide information on the efficacy and safety of the medications.

Key facts

Study ID

NCT00862563

Run by

Boston Medical Center

People needed

85

Starts

2009-05-01

Expected to finish

2013-08-01

Last updated by the study team

2015-04-28

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To be admitted into this study candidates must meet the following criteria:
• DSM-IV-TR Diagnosis of Alcohol Dependence.
• A minimal level of an average of 28 standard drinks per week for women or 35 drinks per week for men over a baseline 28 day consecutive period prior to the screening session during the 90 day time line follow-back.
• Male or Female 21- 65 years of age.
• Able to provide informed consent and comprehend study procedures.
• Negative urine toxicological screen for opioids, cocaine, amphetamines, methamphetamine, and benzodiazepines. The test may be repeated for opioids or benzodiazepines shown to be medically prescribed for an acute disorder. The urine test may also be repeated if the Investigator deems necessary.
• A score of >8 on the Alcohol Use Disorder Identification Test (AUDIT) during screening.
• Must be suitable for outpatient management of alcoholism.
• Express desire to stop drinking or reduce alcohol consumption.
• Provide contact information for themselves or an alternate contact that the staff will call in case of missed appointment.
• Women must be postmenopausal for at least one year, be surgically sterile, or be using an effective method of birth control.
• Must be able to take oral medications, adhere to the regimen and be willing to return for follow up visits.

You may not qualify if…

• Subjects meeting the following criteria will be excluded from the study:
• Dependent on DSM IV-TR drugs or substances other than ethanol, nicotine, or caffeine.
• DSM IV-TR diagnosis of any current Axis I diagnosis other than alcohol dependence, nicotine dependence, or caffeine dependence that in the opinion of the study physicians might require intervention with either pharmacological or non-pharmacological therapy that will interfere with the course of the study.
• Receiving inpatient treatment for alcohol dependence, other then alcohol detoxification, within 4 weeks prior to enrollment into this study.
• Subjects with a score of 10 or greater on the Clinical Institute Withdrawal Assessment for Alcohol-Revised on first or second visits.
• Being treated with acamprosate, disulfiram or naltrexone within two weeks prior to randomization:
• Currently being treated with any of the following medications: a) antipsychotic agents. b) antimanic or anticonvulsant agents. c) sedative- hypnotics. d) chronic opioid treatment. e) psychomotor stimulants- amphetamine derivatives, methylphenidate
• Subjects who are legally mandated to participate in an alcohol treatment program.
• Use of any medication known to inhibit or induce cytochrome P450 3A4 enzymes.
• Subjects who have attempted suicide or who have had suicidal ideation within 30 days of their first visit.
• Subjects with renal disease or history of kidney stones.
• Subjects with AST or ALT >3 times the upper limit of the normal range during screening.
• History of significant neurological disorder.
• Subjects who are pregnant (as assessed by serum HCG) or lactating.
• Subjects known to have clinically significant medical conditions that in the opinion of the study physician would preclude administration of the study medications or limit participation in the clinical trial.
• Subjects with history of treatment with levetiracetam, topiramate or zonisamide.
• Score of 25 or less on the Folstein Mini- Mental examination.
• History of anticonvulsant-induced rash.
• Taking drugs that contain "sulfa" moiety, such as sulfonamides, sulfonylureas, carbonic anhydrase inhibitors, thiazides, and loop diuretics (except ethacrynic acid).
• During the 2 weeks prior to screening subjects who report average drinks per day that are within the guidelines for safe levels of alcohol consumption (i.e. 2 drinks/ day males; 1 drink/day females-HHS standard) will be excluded.
• Subjects with a sulfa allergy.

Where it is running

• Boston University School of Medicine — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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