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Clinical Trials: Alcohol Dependence
IRB No. 08-310-1 (Dr. Marilyn Sanders, PI): UCONN Health Center Research Tissue Registry/Repository
The objective of this project is to develop a research repository for the purpose of performing cancer studies. Information will be gathered form UCHC medical records, molecular and pathological analysis of blood collected and tissue gathered during surgical procedures. The tissue will be obtained during surgical procedures the patient may have elected to have performed at the Health Center in the future. The collection of data will also permit review of relevant information to identify patients who may be eligible for future studies, and to seek permission of patients to be contacted to determine their interest in taking part in future studies. De-identified information will be used for approved research studies and to gather pilot data for extra-mural grant applications.
IRB No. 16-211-3.1 (Dr. Matthew Costello, 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.
IRB No. 19-147-2 (Dr. Jonathan Covault, PI): Dutasteride treatment for reducing heavy drinking in AUD: Predictors of efficacy.
Heavy drinking remains a significant public health problem and is frequently under treated. Although several medications have been shown to help patients stop or reduce drinking, additional medication options are needed as there is considerable variability in effectiveness or tolerability of existing medications for individual patients. Additionally, identification of individual subject level predictors of efficacy are needed to better personalize pharmacotherapy treatment recommendations. This 24-week treatment study will use an innovative randomized placebo controlled step therapy design to examine the safety and efficacy of dutasteride to reduce drinking among a sample of 190 treatment seeking women and men with hazardous levels of alcohol use. At 12-weeks placebo non-responders will transition to dutasteride and dutasteride non-responders will transition to naltrexone, an FDA approved medication with demonstrated efficacy for reducing heavy drinking. 12-week responders (reduction in drinks/week of 60% or greater compared with screening) will continue for an additional 12-weeks on their initial study medication assignment (dutasteride or placebo).