Official Title: “Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2011

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(s) in this Clinical Trial

• Drug: Fluoxetine
  • 20mg once daily for 16 weeks
• Drug: Dextrose
  • Once daily for 16 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Sequential antidepressant pharmacotherapy with (20mg) fluoxetine, begun 8 weeks prior to and extended throughout brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.
• Placebo Comparator: 2
  • Sequential placebo medication, begun 8 weeks prior to and extended throughout brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.

Primary Measures

• Self-reported smoking abstinence via Timeline Followback (TLFB)
  • Time Frame: One year
    Safety Issue?: No
• Biochemically verified smoking abstinence via carbon monoxide and saliva cotinine
  • Time Frame: One year
    Safety Issue?: No

Secondary Measures

• Self-reported depressive symptoms
  • Time Frame: One year
    Safety Issue?: No
• Self-reported nicotine withdrawal symptoms
  • Time Frame: One year
    Safety Issue?: No

Inclusion Criteria:

• Regular smoker for at least one year
• Currently smokes at least 10 cigarettes per day
• Elevated depressive symptoms
• Uses no other tobacco products

Exclusion Criteria:

• Current Axis I disorder, including Major Depressive Disorder
• Psychoactive substance abuse or dependence (excluding nicotine dependence) within past year
• Current use of psychotropic medication
• Use of antidepressant medication within past 6 months
• Current suicidal risk
• History of significant medical illness, such as cardiovascular disease, neurological, gastrointestinal, or other systemic illness
• Pregnancy or breast feeding
• Use of nicotine replacement therapy or of any medication for smoking cessation not provided by the researchers during the quit attempt

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?: Accepts Healthy Volunteers

Lead Sponsor: Butler Hospital

Overall Clinical Trial Officials and Contacts

Richard A. Brown, Ph.D. Principal Investigator Butler Hospital  

Overall Contact: Richard A. Brown, Ph.D. (401) 455-6254 richard_brown@brown.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00578669

Study ID Number: PHI0710-002

ClinicalTrials.gov Identifier: NCT00578669

Health Authority: United States: Federal Government

Website for Butler Hospital with links to research