Predicting Alcoholics' Treatment Responses to a Selective Serotonin Re-uptake Inhibitor (SSRI)
Primary Purpose
Alcoholism, Alcohol Abuse
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Citalopram + MI
Placebo + MI
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholism focused on measuring Clinical trial, Alcoholism, Alcohol, Pharmacogenetics, Citalopram, Genotype, Therapy compliance, Serotonin inhibitor, Alcoholism/alcohol abuse therapy
Eligibility 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
Sites / Locations
- University of Cincinnati
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
citalopram
Placebo
Outcomes
Primary Outcome Measures
Percent days abstinent
Secondary Outcome Measures
Percent heavy drinking days
Full Information
NCT ID
NCT00249405
First Posted
November 4, 2005
Last Updated
November 2, 2010
Sponsor
University of Cincinnati
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT00249405
Brief Title
Predicting Alcoholics' Treatment Responses to a Selective Serotonin Re-uptake Inhibitor (SSRI)
Official Title
Predicting Alcoholics' Treatment Responses to an SSRI
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Cincinnati
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Alcohol Abuse
Keywords
Clinical trial, Alcoholism, Alcohol, Pharmacogenetics, Citalopram, Genotype, Therapy compliance, Serotonin inhibitor, Alcoholism/alcohol abuse therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
citalopram
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Citalopram + MI
Other Intervention Name(s)
celexa
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Placebo + MI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent days abstinent
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Percent heavy drinking days
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert M. Anthenelli, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45237
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20598843
Citation
Thompson RD, Heffner JL, Strong JA, Blom TJ, Anthenelli RM. Relationship between the serotonin transporter polymorphism and obsessive-compulsive alcohol craving in alcohol-dependent adults: a pilot study. Alcohol. 2010 Aug;44(5):401-6. doi: 10.1016/j.alcohol.2010.05.008. Epub 2010 Jul 3.
Results Reference
derived
PubMed Identifier
20105415
Citation
Heffner JL, Tran GQ, Johnson CS, Barrett SW, Blom TJ, Thompson RD, Anthenelli RM. Combining motivational interviewing with compliance enhancement therapy (MI-CET): development and preliminary evaluation of a new, manual-guided psychosocial adjunct to alcohol-dependence pharmacotherapy. J Stud Alcohol Drugs. 2010 Jan;71(1):61-70. doi: 10.15288/jsad.2010.71.61.
Results Reference
derived
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Predicting Alcoholics' Treatment Responses to a Selective Serotonin Re-uptake Inhibitor (SSRI)
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