Predicting Alcoholics' Treatment Responses to a Selective Serotonin Re-uptake Inhibitor (SSRI)
Condition: Alcoholism; Alcohol Abuse
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Citalopram + MI; Placebo + MI
Intervention type(s): Drug; Behavioral
Intervention description(s): 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.; 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.
Other intervention name(s): celexa
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Clinical trial; Alcoholism; Alcohol; Pharmacogenetics; Citalopram; Genotype; Therapy compliance; Serotonin inhibitor; Alcoholism/alcohol abuse therapy