Predicting Alcoholics' Treatment Responses to a Selective Serotonin Re-uptake Inhibitor (SSRI)
Information source: University of Cincinnati
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcoholism; Alcohol Abuse
Intervention: Citalopram + MI (Drug); Placebo + MI (Behavioral)
Phase: Phase 2
Status: Completed
Sponsored by: University of Cincinnati Official(s) and/or principal investigator(s):
Robert M. Anthenelli, MD, Principal Investigator, Affiliation: University of Cincinnati
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.
Clinical Details
Official title: Predicting Alcoholics' Treatment Responses to an SSRI
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Percent days abstinent
Secondary outcome: Percent heavy drinking days
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.
Eligibility
Minimum age: 21 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University of Cincinnati, Cincinnati, Ohio 45237, United States
Additional Information
Starting date: February 2005
Last updated: November 2, 2010
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