Sertraline Pharmacotherapy for Alcoholism Subtypes
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      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. This involved administering sertraline (to a maximum of 200 mg/day) or
      an inactive placebo for a 14-week treatment period.
    

Detailed description: 
      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 SSRIs 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 parallel-group, prospective design in which randomization is balanced on
      patient subtype (early-onset/late-onset) and other relevant pretreatment measures with an
      approximately equal number of subjects assigned to treatment with sertraline (to a maximum of
      200 mg/day) or placebo. The study will include a 14-week treatment period; because the 2
      weeks are for medication taper, efficacy will be evaluated over the first 12 treatment weeks.
      A total of 160 early-onset or late-onset alcoholics will be randomized. 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 name(s): Sertraline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sertraline (to a maximum of 200 mg/day) for 14-week treatment period; Placebo for 14-week treatment period
Other intervention name(s): Zoloft
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Alcohol Drinking; Alcohol Dependence; Sertraline Pharmacotherapy; Alcoholism Subtypes; Early- versus Late-Onset Alcoholism