Interdisciplinary Study of Two Novel Anticonvulsants in Alcoholism
Status:
Terminated
Trial end date:
2013-08-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Boston Medical Center
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)