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Clinical Trial Details
Zonisamide treatment of Alcohol Use Disorder: An Evaluation of Efficacy and Mechanism of Action
Clinical Trial ( IRB ) #: 16-148-3
Title: Zonisamide treatment of Alcohol Use Disorder: An Evaluation of Efficacy and Mechanism of Action
Principal Investigator: Dr. Jonathan Covault
Description: Alcohol use disorders (AUDs) are highly prevalent (lifetime prevalence estimated to be >30% in the U.S. general population, and >40% in military veterans) and have large detrimental impacts on patients, their families and society. The number of FDA-approved medication treatments for alcoholism is limited in number (naltrexone, acamprosate, disulfiram) and have only modest effects. Anticonvulsant (anti-epileptic) medications have shown evidence of efficacy in treating alcoholism. Zonisamide (ZNS) is an anticonvulsant and a promising potential treatment for AUDs. Zonisamide reduces drinking, craving for alcohol, and anxiety in subjects with AUDs. We (Arias, Feinn, Oncken, Covault, and Kranzler. 2010) completed a randomized, placebo-controlled pilot trial of zonisamide for treating alcohol dependence, which showed reductions in heavy drinking, overall drinking, and alcohol craving with the medication. Zonisamide was very well tolerated in the pilot study. Recently, another small placebo-controlled trial of zonisamide showed advantages of the medication over placebo in reducing drinking. However, no definitive study of ZNS treatment for alcoholism has been performed. In this study we will test if the medication zonisamide can reduce harmful drinking patterns, and try to determine whether medication response can be predicted by a few key factors such as genotype, age of onset of alcoholism (early vs. late), or stress-reactivity. This study includes an innovative pharmacogenomics secondary component that examines whether the total number of risk alleles for a panel of previously identified alcohol use and stress response risk alleles is associated with treatment response. The study is funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) via a grant to Dr. Arias at Yale University and seeks to recruit 160 subjects across 2 clinical sites (West Haven VA Alcohol Research Center and UConn Health Center). Understanding how ZNS works, and for whom it works best, will advance pharmacologic treatment for alcohol use disorders and bring us closer to personalized treatment.
Classification:
  Addiction/Substance Abuse
Eligibility Criteria: Check with study contact
How to Contact: Marcia Lawlor. Telephone: 860-679-6730. Email: lawlor@uchc.edu
Enrollment Status/Comments: Enrolling/recruiting. For current recruitment status, please check with study contact.