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Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms

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ClinicalTrials.gov Identifier: NCT00578669
Recruitment Status : Completed
First Posted : December 21, 2007
Results First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Butler Hospital

Tracking Information
First Submitted Date  ICMJE December 19, 2007
First Posted Date  ICMJE December 21, 2007
Results First Submitted Date  ICMJE August 9, 2018
Results First Posted Date  ICMJE October 16, 2018
Last Update Posted Date October 16, 2018
Study Start Date  ICMJE April 2008
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2018)
Number of Participants Achieving Smoking Abstinence [ Time Frame: One year ]
7-day point prevalence abstinence
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
  • Self-reported smoking abstinence via Timeline Followback (TLFB) [ Time Frame: One year ]
  • Biochemically verified smoking abstinence via carbon monoxide and saliva cotinine [ Time Frame: One year ]
Change History Complete list of historical versions of study NCT00578669 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2018)
Self-reported Depressive Symptoms [ Time Frame: One year ]
Self-reported depressive symptoms based on the Center for Epidemiologic Studies-Depression (CES-D) scale. CES-D consists of 20 items, with total scores on the scale ranging from 0 - 60. Higher scores are indicative of greater levels of depressive symptoms.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
  • Self-reported Depressive Symptoms [ Time Frame: One year ]
  • Self-reported nicotine withdrawal symptoms [ Time Frame: One year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms
Official Title  ICMJE Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Major Depressive Disorder
  • Nicotine Dependence
  • Depression
Intervention  ICMJE
  • Drug: Fluoxetine
    20mg once daily for 16 weeks
    Other Name: Prozac
  • Drug: Dextrose
    Once daily for 16 weeks
Study Arms  ICMJE
  • 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 (dextrose), begun 8 weeks prior to and extended throughout brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.
    Intervention: Drug: Dextrose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2007)
206
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00578669
Other Study ID Numbers  ICMJE PHI0710-002
1R01DA023190 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Butler Hospital
Study Sponsor  ICMJE Butler Hospital
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Richard A. Brown, Ph.D. Butler Hospital
PRS Account Butler Hospital
Verification Date September 2018

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