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Clinical Trials: Alcohol Dependence
IRB No. 16-211-3 (Dr. Mark Litt, PI): Individualized Assessment and Treatment Program for Alcoholism: Treatment and Mechanisms
This is a study to test different outpatient treatments for alcohol problems. Interested persons can reach us by phone to be scheduled for an interview. Those eligible for the study will be asked to engage in a cellphone-based recording procedure prior to start of treatment to allow us to get a sense of their drinking problems. For some patients, this information will be used by a therapist for tailoring an individualized cognitive-behavioral treatment for that person. This individualized assessment and treatment program (IATP) will be compared to a more conventional packaged cognitive-behavioral treatment (PCBT), and to a Case Management condition (CaseM). Each treatment will be delivered individually, and will last 12 weeks, with another 18 months of follow-ups scheduled at 3-month intervals. Additional cellphone monitoring periods will be scheduled during treatment and afterwards, during the follow-up period. All of the treatments delivered here have shown excellent results for people with alcohol problems. We will recruit 207 men and women meeting criteria for alcohol use disorder. Eligible persons will be randomly assigned to one of the three treatments. 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. Thus the study will help us find out what are active aspects of treatment for alcohol use disorder.
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.