Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers
Condition: Depression; Smoking
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This project is a treatment-matching study to test whether adding antidepressant
      pharmacotherapy to behavioral cessation treatment improves the depression-prone smoker's
      ability to quit, while not undermining cessation goals for the smoker who lacks a history of
      depression. The study target is to randomize 120 smokers with a prior history of depression
      and 120 smokers who lack such a history to a double-blind treatment with either 60 mg
      fluoxetine or placebo, while they undergo cognitive behavioral treatment to quit smoking.
    

Detailed description: 
      The aim of this research is to examine whether adding antidepressant pharmacotherapy to
      behavioral cessation treatment improves the depression-prone smoker's ability to quit, while
      not undermining cessation for the smoker who lacks a history of depression, by randomizing
      smokers both with and without such a history to double-blind treatment with either 60 mg
      fluoxetine or placebo. The primary Depressive Episode Hypothesis states that the stress of
      quitting smoking and the biological challenge of nicotine withdrawal trigger a depressive
      episode in vulnerable individuals. To the extent that episode onset can be prevented by
      prophylactic administration of antidepressant pharmacotherapy, smokers with a history of
      depression will show significantly higher abstinence rates when treated with fluoxetine than
      placebo, whereas no drug effect will be evident for history negative smokers who lack the
      depressive diathesis. An alternative generalized withdrawal hypothesis construes
      post-cessation dysphoria as one general manifestation of a nicotine withdrawal syndrome that
      occurs independently of depressive vulnerability, and predicts that fluoxetine, as compared
      to placebo, will uniformly improve cessation outcomes, regardless of whether smokers possess
      the diathesis for depression. Over period of four years, the study hopes to randomize 120
      smokers with a history of depression and 120 smokers who lack such a history to double-blind
      treatment with either 60 mg fluoxetine or placebo, while they undergo group cognitive
      behavioral treatment to quit smoking. To allow plasma drug levels to stabilize before
      quitting smoking, drug or placebo treatment begins 3 weeks before quitting smoking and
      continues for an additional 8 weeks following the quit date. Participants will be followed up
      monthly for 4 months after the end of treatment in order to assess the main study outcome;
      abstinence from smoking 6 months after the quit date.
    

Intervention name(s): Fluoxetine; Behavioral group smoking cessation treatment; Placebo
Intervention type(s): Drug; Behavioral; Drug
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Depression; Fluoxetine; Nicotine dependence