Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms
Condition: Major Depressive Disorder; Nicotine Dependence; Depression
MeSH terms: Tobacco Use Disorder; Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to determine whether, among smokers with elevated
      depressive symptoms, sequential antidepressant pharmacotherapy with fluoxetine (20 mg) begun
      8 weeks prior to and extended throughout standard smoking cessation treatment with
      transdermal nicotine patch (ST-TNP) will result in superior short-and long-term smoking
      cessation outcomes compared to sequential pharmacotherapy with placebo medication combined
      with ST-TNP. The secondary aim of the study is to test the hypothesis that, among smokers
      with elevated depressive symptoms, sequential treatment with fluoxetine will result in lower
      levels of depressive symptoms and negative mood and higher levels of positive mood
      immediately prior to and throughout the course of smoking cessation treatment relative to the
      placebo condition.
    

Detailed description: 
      Cigarette smoking is the leading cause of death and disability in the United States,
      accounting for over 430,000 deaths in this country every year. The selection hypothesis of
      smoking prevalence argues that smokers who are unable to quit successfully are likely to
      possess risk factors or characteristics that make it difficult to quit, such as nicotine
      dependence and psychiatric comorbidity. As such, significant strides in helping "today's"
      smokers quit will ultimately be found in the ability to develop specialized treatments that
      target the particular needs of subgroups of smokers, especially those who are at higher risk
      for relapse. Depression is the psychiatric disorder most frequently associated with cigarette
      smoking in adults and strong associations have been demonstrated between cigarette smoking
      and both depressive disorders and depressive symptoms. In fact, a prospective analysis from
      the National Health and Nutrition Examination Survey showed that smokers with elevated
      depressive symptoms were 40% less likely than nondepressed smokers to have quit nine years
      later.

      The development of an efficacious, specialized treatment of nicotine dependence for smokers
      with elevated depressive symptoms would address this need by providing physicians with an
      effective treatment alternative for the large number of smokers with depressive symptoms seen
      daily in clinical practice. This study examines the hypothesis that smokers with elevated
      depressive symptoms treated with fluoxetine 8 weeks prior to quitting and extended throughout
      8 weeks of standard treatment with the nicotine patch post-quit will demonstrate superior
      cessation outcomes compared to placebo medication combined with standard treatment and the
      nicotine patch, administered with the identical treatment schedule. A secondary hypothesis is
      to examine whether reductions in depressive symptoms and negative mood and increases in
      positive mood will be greater for those in the sequential fluoxetine versus placebo
      condition.
    

Intervention name(s): Fluoxetine; Dextrose
Intervention type(s): Drug; Drug
Intervention description(s): 20mg once daily for 16 weeks; Once daily for 16 weeks
Other intervention name(s): Prozac
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Smoking Cessation; Tobacco Use Cessation; Antidepressants