Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Butler Hospital
ClinicalTrials.gov Identifier:
NCT00578669
First received: December 19, 2007
Last updated: August 26, 2014
Last verified: March 2012

December 19, 2007
August 26, 2014
April 2008
July 2013   (final data collection date for primary outcome measure)
  • Self-reported smoking abstinence via Timeline Followback (TLFB) [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Biochemically verified smoking abstinence via carbon monoxide and saliva cotinine [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00578669 on ClinicalTrials.gov Archive Site
  • Self-reported depressive symptoms [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Self-reported nicotine withdrawal symptoms [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Major Depressive Disorder
  • Nicotine Dependence
  • Depression
  • Drug: Fluoxetine
    20mg once daily for 16 weeks
    Other Name: Prozac
  • Drug: Dextrose
    Once daily for 16 weeks
  • 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.
    Intervention: Drug: Fluoxetine
  • Placebo Comparator: 2
    Sequential placebo medication, begun 8 weeks prior to and extended throughout brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.
    Intervention: Drug: Dextrose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
206
November 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00578669
PHI0710-002, 1 R01 DA023190
Yes
Butler Hospital
Butler Hospital
National Institute on Drug Abuse (NIDA)
Principal Investigator: Richard A. Brown, Ph.D. Butler Hospital
Butler Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP