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Clinical Trials: Alcohol Dependence
IRB No. 16-148-3.1 (Dr. Jonathan Covault, PI): Zonisamide treatment of Alcohol Use Disorder: An Evaluation of Efficacy and Mechanism of Action
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.
IRB No. 16-211-3.1 (Dr. Mark Litt, PI): Individualized Assessment and Treatment Program for Alcoholism: Treatment and Mechanisms
Through our 2009 R-21 pilot project we developed a cellphone-based experience sampling (ES) procedure that assesses, in near real time, coping skills and associated thoughts and feelings that contribute to preventing relapse in alcoholics in treatment. We propose using the experience sampling procedure prior to treatment to collect data on thoughts, feelings and behaviors that patients have when they encounter drinking situations in real life. This information will be used by a therapist tailoring an individualized cognitive-behavioral treatment for each particular patient. The individualized assessment and treatment program (IATP) will be compared to a more conventional packaged cognitive-behavioral treatment (PCBT), and to a Case Management Control condition (CaseM). 207 men and women meeting criteria for alcohol use disorder will be randomly assigned to 12 weekly sessions of either CaseM, PCBT or IATP. Follow-ups will be conducted at posttreatment, and at 3-month intervals out to 27 months. The use of momentary assessments of thoughts, feelings and behaviors will allow us to determine what patients are actually doing, in close to real time, to initiate and maintain their own sobriety. The use of experience sampling in the follow-up period will allow us to determine whether the mechanisms that were active in initiation and early maintenance continue to be active in maintaining long-term abstinence. By comparing IATP with CaseM and PCBT we will be able to control for the general effects of study participation (i.e., "common factors"), the effects of being in a treatment study and receiving manualized treatment, general skills training (psychoeducation), and therapist presence.