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Predicting Alcoholics' Treatment Responses to a Selective Serotonin Re-uptake Inhibitor (SSRI)

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ClinicalTrials.gov Identifier: NCT00249405
Recruitment Status : Completed
First Posted : November 7, 2005
Last Update Posted : November 3, 2010
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Alcoholism Alcohol Abuse Drug: Citalopram + MI Behavioral: Placebo + MI Phase 2

Detailed Description:

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Predicting Alcoholics' Treatment Responses to an SSRI
Study Start Date : February 2005
Primary Completion Date : October 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
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.
Other Name: celexa
Placebo Comparator: 2
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.

Outcome Measures

Primary Outcome Measures :
  1. Percent days abstinent [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Percent heavy drinking days [ Time Frame: 24 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Outpatients with a diagnosis of DSM-IV alcohol dependence
  • Not morbidly obese or underweight
  • Express desire to quit or cut down on drinking for duration of trial

Exclusion Criteria:

  • Clinically significant laboratory evidence of diseases
  • Have active psychological disorders other than alcoholism
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00249405

United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45237
Sponsors and Collaborators
University of Cincinnati
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Robert M. Anthenelli, MD University of Cincinnati
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Anthenelli, M.D., Principle Investigator
ClinicalTrials.gov Identifier: NCT00249405     History of Changes
Other Study ID Numbers: NIAAAANT013957-B
R01AA013957 ( U.S. NIH Grant/Contract )
NIH Grant R01 AA013957-02
First Posted: November 7, 2005    Key Record Dates
Last Update Posted: November 3, 2010
Last Verified: November 2010

Keywords provided by University of Cincinnati:
Clinical trial
Therapy compliance
Serotonin inhibitor
Alcoholism/alcohol abuse therapy

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents