Official Title: “Sertraline Pharmacotherapy for Alcoholism Subtypes”

The purpose of this study is to determine whether Sertraline, compared to placebo, is effective in the treatment of alcohol dependence as a function of the subtype of alcoholic patient being treated.

Study Type: Interventional

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

Study Primary Completion Date: March 2009

In an effort to broaden the options for pharmacotherapy of alcoholism, this study will examine the effects of sertraline, a selective serotonin reuptake inhibitor (SSRI), for the treatment of alcohol dependence. The study is based on evidence that, although SSRI therapy is not appropriate for all alcoholics, there exists a substantial subgroup of alcoholics for whom SSRI's appear to exert a clinically important effect. Sertraline is among the most widely prescribed psychotropic medications in the world. Consequently, this study will examine the safety and efficacy of sertraline, the mechanism and duration of those effects and the best method for subtyping alcoholics to identify individuals for whom the medication is most likely to produce a clinically important reduction in drinking behavior.

The study employs a stratified, parallel groups, prospective design in which patient subtype (early-onset/late-onset) is used to assign subjects randomly to medication group in a placebo-controlled trial of sertraline. The study will include a 14-week treatment period, during which 160 early-onset or late-onset alcoholics will receive either sertraline (to a maximum of 200 mg/day) or matching placebo. Daily process measures of positive and negative events, global perceived stress, mood, desire to drink, and drinking frequency and intensity, collected using interactive voice response technology, will provide insight into the mechanisms by which sertraline may exert its effects. Coping-skills training will be provided weekly for the first 6 weeks, then every other week for the last 8 weeks of the study. A 6-month post-treatment follow-up period will evaluate the duration of medication effects.

This study will also examine the relation between genotypes at a number of relevant loci and both risk of alcohol dependence and response to sertraline treatment.

Intervention(s) in this Clinical Trial

• Drug: sertraline
  • sertraline (to a maximum of 200 mg/day) for 14-week treatment period
• Drug: Placebo
  • placebo for 14-week treatment period

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • sertraline
• Placebo Comparator: 2
  • Placebo

Primary Measures

• Number of days on which subjects drink
  • Time Frame: 14-week treatment period, 6 months follow up
    Safety Issue?: No

Secondary Measures

• Likelihood of total abstinence during the treatment period
  • Time Frame: 14-week treatment period, 6 months follow up
    Safety Issue?: No
• Mean daily alcohol consumption
  • Time Frame: 14-week treatment period, 6 months follow up
    Safety Issue?: No
• Number of days of heavy drinking (defined as >= 4 drinks for females and >= 5 drinks for males)
  • Time Frame: 14-week treatment period; 6 months follow up
    Safety Issue?: No
• Carbohydrate-deficient transferrin levels
  • Time Frame: 14-week treatment period; 6 months follow up
    Safety Issue?: No
• Level of alcohol-related problems
  • Time Frame: 14-week treatment period; 6 months follow up
    Safety Issue?: No
• Frequency of serious adverse events
  • Time Frame: 14-week treatment period; 6 months follow up
    Safety Issue?: Yes
• Frequency of moderate or severe adverse events
  • Time Frame: 14-week treatment period; 6 months follow up
    Safety Issue?: Yes

Inclusion Criteria:

• Current episode (i.e., in the preceding month) of alcohol dependence defined by Diagnostic and Statistical Manual of Mental Disorders 4th ed (DSM-IV) criteria
• 18-65 years of age
• Abstinent from alcohol for a period of at least 3 days prior to baseline research assessment
• Able to read English and complete study evaluations
• Male, or if female, without active reproductive potential
• Participants will have signed informed consent

Exclusion Criteria:

• Currently meets criteria for dependence on a psychoactive substance other than alcohol and nicotine
• Regular use of psychoactive drugs including anxiolytics and antidepressants.
• Current use of disulfiram or naltrexone
• Current major depression or psychosis (or other severe psychiatric disability e.g., suicidality, current mania)
• Significant underlying medical conditions such as hepatic, cerebral, renal, thyroid, or cardiac pathology, which in the opinion of the evaluating physician would preclude the patient from study adherence or be of potential harm to the subject

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Connecticut

Overall Clinical Trial Officials and Contacts

Henry R. Kranzler, MD Principal Investigator University of Connecticut Health Center  

Overall Contact: Kristen A. Tremblay, MPH 860-679-4755 tremblay@psychiatry.uchc.edu

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00368550

Study ID Number: 03-225-2

ClinicalTrials.gov Identifier: NCT00368550

Health Authority: United States: Federal Government

University of Connecticut Health Center, Dept. of Psychiatry Research Studies