Predicting Alcoholics' Treatment Responses to a Selective Serotonin Re-Uptake Inhibitor (SSRI) - Tabular View

Tracking Information

First Received Date ^ICMJE

November 4, 2005

Last Updated Date

May 8, 2009

Start Date ^ICMJE

February 2005

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percent days abstinent [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Percent days abstinent

Change History

Complete list of historical versions of study NCT00249405 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Percent heavy drinking days [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Percent heavy drinking days

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Predicting Alcoholics' Treatment Responses to an SSRI

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.

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Alcoholism
Alcohol Abuse

Intervention ^ICMJE

Drug: Citalopram + MI
Behavioral: Placebo + MI

Study Arms / Comparison Groups

Experimental: citalopram
Placebo Comparator: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Stephanie L Nolting, M.Ed.

513-558-7183

stephanie.nolting@uc.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00249405

Responsible Party

Robert Anthenelli, M.D., Principle Investigator

Study ID Numbers ^ICMJE

NIAAAANT013957-B, NIH Grant R01 AA013957-02

Study Sponsor ^ICMJE

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Robert M. Anthenelli, MD

University of Cincinnati

Information Provided By

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP