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Sponsors and Collaborators: |
University of Connecticut National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
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Information provided by: | University of Connecticut |
ClinicalTrials.gov Identifier: | NCT00368550 |
The purpose of this study is to determine whether Sertraline, compared to placebo, is effective in the treatment of alcohol dependence as a function of the subtype of alcoholic patient being treated.
Condition | Intervention | Phase |
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Alcoholism Alcohol Drinking Alcohol Dependence |
Drug: sertraline Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Sertraline Pharmacotherapy for Alcoholism Subtypes |
Estimated Enrollment: | 160 |
Study Start Date: | February 2004 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
sertraline
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Drug: sertraline
sertraline (to a maximum of 200 mg/day) for 14-week treatment period
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2: Placebo Comparator
Placebo
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Drug: Placebo
placebo for 14-week treatment period
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In an effort to broaden the options for pharmacotherapy of alcoholism, this study will examine the effects of sertraline, a selective serotonin reuptake inhibitor (SSRI), for the treatment of alcohol dependence. The study is based on evidence that, although SSRI therapy is not appropriate for all alcoholics, there exists a substantial subgroup of alcoholics for whom SSRI's appear to exert a clinically important effect. Sertraline is among the most widely prescribed psychotropic medications in the world. Consequently, this study will examine the safety and efficacy of sertraline, the mechanism and duration of those effects and the best method for subtyping alcoholics to identify individuals for whom the medication is most likely to produce a clinically important reduction in drinking behavior.
The study employs a stratified, parallel groups, prospective design in which patient subtype (early-onset/late-onset) is used to assign subjects randomly to medication group in a placebo-controlled trial of sertraline. The study will include a 14-week treatment period, during which 160 early-onset or late-onset alcoholics will receive either sertraline (to a maximum of 200 mg/day) or matching placebo. Daily process measures of positive and negative events, global perceived stress, mood, desire to drink, and drinking frequency and intensity, collected using interactive voice response technology, will provide insight into the mechanisms by which sertraline may exert its effects. Coping-skills training will be provided weekly for the first 6 weeks, then every other week for the last 8 weeks of the study. A 6-month post-treatment follow-up period will evaluate the duration of medication effects. This study will also examine the relation between genotypes at a number of relevant loci and both risk of alcohol dependence and response to sertraline treatment.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kristen A. Tremblay, MPH | 860-679-4755 | tremblay@psychiatry.uchc.edu |
United States, Connecticut | |
University of Connecticut Health Center | Recruiting |
Farmington, Connecticut, United States, 06030 | |
Contact: Kristen A. Tremblay, MPH 860-679-4755 tremblay@psychiatry.uchc.edu | |
Principal Investigator: Henry R. Kranzler, MD | |
Sub-Investigator: Howard Tennen, Ph.D. | |
Sub-Investigator: Jonathan Covault, M.D., Ph.D. | |
Sub-Investigator: Cheryl Oncken, M.D., M.P.H. | |
Sub-Investigator: Albert Arias, M.D. | |
Sub-Investigator: Stephen Armeli, Ph.D. | |
Sub-Investigator: Carolyn Drazinic, M.D., Ph.D. |
Principal Investigator: | Henry R. Kranzler, MD | University of Connecticut Health Center |
Responsible Party: | University of Connecticut Health Center ( Henry R. Kranzler, M.D. ) |
Study ID Numbers: | 03-225-2, NIAAAKRA013631-04 |
Study First Received: | August 22, 2006 |
Last Updated: | November 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00368550 |
Health Authority: | United States: Federal Government |
Sertraline Pharmacotherapy Alcoholism Subtypes Early- vs. Late-Onset Alcoholism |
Mental Disorders Alcoholism Substance-Related Disorders Drinking Behavior Sertraline |
Disorders of Environmental Origin Alcohol-Related Disorders Alcohol Drinking Serotonin |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Serotonin Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Serotonin Uptake Inhibitors Central Nervous System Agents Pharmacologic Actions Antidepressive Agents |