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Clinical Trials: Addiction/Substance Abuse
IRB No. 07-131-1 (Dr. Jonathan Covault, PI): Behavioral Gene Bank
The purpose of this registry/repository is to collect diagnostic data (psychiatric and medical diagnoses) and tissue specimens from subjects and/or family members in order to build a Behavioral Gene Bank (BGB). The registry/repository aims to study; subjects with known or suspected genetic or medical syndromes; families with high concentrations of psychiatric illness; and subjects with dysmorphic features or other clinical characteristics suggestive of a genetic or chromosomal disorder. Relatives of individuals with these features and healthy controls will also participate. Subjects will be invited to participate in further behavioral studies in the future.
IRB No. 089-89-1 (Dr. Victor Hesselbrock, PI): Participating Center for Genetics for Alcoholism (Collaborative Study) COGA
Study description not available
IRB No. 1337-85-1 (Dr. Victor Hesselbrock, PI): (1) Neuroelectric Correlates of Risk for Alcohol Dependence (2) Deviance Proneness and the Risk for Alcohol Dependence
Study description not available
IRB No. 13-056-2 (Dr. Jonathan Covault, PI): Dutasteride Treatment for the Reduction of Heavy Drinking
This study will use a 12-week randomized, placebo controlled clinical design to examine the safety and efficacy of dutasteride treatment (1mg daily) combined with medical management to help reduce or stop drinking among a sample of 160 men with hazardous levels of alcohol use. Other aims are: to examine the durability of effects of dutasteride treatment on drinking and heavy drinking during a six-month post-treatment follow-up; to examine whether treatment response is moderated by a common genetic variation, H5Q, in the neuroactive steroid biosynthetic enzyme 3a-hydroxysteroid dehydrogenase gene AKR1C3 that has been associated with alcohol dependence; and to examine the potential effects of dutasteride on the relations among daily mood and daily events on drinking and heavy drinking, and the potential effects of dutasteride on daily reports of alcohol subjective effects to identify potential intermediate effects of dutasteride on treatment outcomes.
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.