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| Sponsor: | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
|---|---|
| Information provided by: | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| ClinicalTrials.gov Identifier: | NCT00249405 |
Purpose
This study is being done to determine if citalopram is safe and effective in the treatment of alcohol dependence. A second purpose is to evaluate whether alcohol dependent individuals who differ in a specific genetic marker respond differently to citalopram.
Citalopram is a drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of depression. It belongs to a category of medications called selective serotonin re-uptake inhibitors or SSRIs. The U.S. FDA has not approved citalopram for the treatment of alcohol dependence. Therefore, it is being used "off-label" in this study.
| Condition | Intervention | Phase |
|---|---|---|
|
Alcoholism Alcohol Abuse |
Drug: Citalopram + MI Behavioral: Placebo + MI |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Predicting Alcoholics' Treatment Responses to an SSRI |
| Estimated Enrollment: | 200 |
| Study Start Date: | February 2005 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
citalopram
|
Drug: Citalopram + MI
14-week citalopram treatment + Motivational Interview (MI) and 9 brief sessions of a manual-guided Compliance Enhancement Therapy; post-treatment follow-up assessments will be conducted at 4, 12 and 24 weeks.
|
|
2: Placebo Comparator
Placebo
|
Behavioral: Placebo + MI
placebo + single Motivational Interview (MI) and 9 brief sessions of a manual-guided Compliance Enhancement Therapy; post-treatment follow-up assessments will be conducted at 4, 12 and 24 weeks.
|
Relapse to alcoholism remains a vexing clinical and national health problem. Efforts to match alcohol dependent patients to specific treatments based on their clinical characteristics have produced mixed results. Pharmacogenetics (the study of genetic influences on therapeutic response to drugs) offers a powerful new tool to match specific elements of an individual patient's complex genetic blueprint with targeted pharmacotherapies to which that individual may optimally respond.
The purpose of this proposed research is to apply pharmacogenetic techniques to predict which alcohol dependent patients will respond favorably to a trial of a selective serotonin re-uptake inhibitor (SSRI) for the prevention of alcoholism relapse. Our central hypothesis is that genetic differences affecting serotonin transporter function will influence an alcohol dependent individual's treatment response to the SSRI, citalopram. To test this hypothesis, we will perform a 14-week, randomized, double blind, parallel group comparison of citalopram and placebo in treatment seeking outpatients who meet DSM-IV criteria for alcohol dependence. All subjects will receive a single Motivational Interview and 9 brief sessions of a manual-guided Compliance Enhancement Therapy designed to promote treatment adherence and enhance motivation to quit or cut down on drinking. Post-treatment follow-up assessments will be conducted at 4, 12 and 24 weeks. Subjects' DNA will be genotyped to determine allelic variants in the promoter region of the serotonin transporter gene that have been found to markedly affect serotonin reuptake and influence treatment responsiveness to SSRIs.
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Stephanie L Nolting, M.Ed. | 513-558-7183 | stephanie.nolting@uc.edu |
| United States, Ohio | |
| University of Cincinnati | Recruiting |
| Cincinnati, Ohio, United States, 45237 | |
| Contact: Robert M. Anthenelli, MD 513-558-7193 anthenrm@ucmail.uc.edu | |
| Principal Investigator: Robert M. Anthenelli, MD | |
| Principal Investigator: | Robert M. Anthenelli, MD | University of Cincinnati |
More Information
| Responsible Party: | Principle Investigator ( Robert Anthenelli, M.D. ) |
| Study ID Numbers: | NIAAAANT013957-B, NIH Grant R01 AA013957-02 |
| Study First Received: | November 4, 2005 |
| Last Updated: | May 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00249405 History of Changes |
| Health Authority: | United States: Federal Government |
|
Clinical trial Alcoholism Alcohol Pharmacogenetics Citalopram |
Genotype Therapy compliance Serotonin inhibitor Alcoholism/alcohol abuse therapy |
|
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Disorders of Environmental Origin Antiparkinson Agents Cholinergic Agents Mental Disorders Therapeutic Uses Substance-Related Disorders |
Alcohol-Related Disorders Antidepressive Agents, Second-Generation Dexetimide Antidepressive Agents Serotonin Uptake Inhibitors Citalopram Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Autonomic Agents Alcoholism Peripheral Nervous System Agents Central Nervous System Agents |
