Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249405
Status:
COMPLETED
Last Update Posted:
2010-11-03
First Post:
2005-11-04
Brief Title:
Predicting Alcoholics Treatment Responses to a Selective Serotonin Re-uptake Inhibitor SSRI
Sponsor:
University of Cincinnati
Organization:
University of Cincinnati
Study Overview
Official Title:
Predicting Alcoholics Treatment Responses to an SSRI
Status:
COMPLETED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US 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 US FDA has not approved citalopram for the treatment of alcohol dependence Therefore it is being used off-label in this study
Citalopram is a drug approved by the US 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 US 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 patients 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 individuals 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
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 individuals 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIH Grant R01 AA013957-02 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01AA013957 |
| R01AA013957 | NIH | None | None |