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Sponsors and Collaborators: |
Butler Hospital National Institute on Drug Abuse (NIDA) |
Information provided by: | Butler Hospital |
ClinicalTrials.gov Identifier: | NCT00578669 |
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.
Condition | Intervention | Phase |
Major Depressive Disorder Nicotine Dependence Depression |
Drug: Fluoxetine Drug: Dextrose |
Phase III |
MedlinePlus related topics: | Antidepressants Depression Smoking Smoking Cessation |
ChemIDplus related topics: | Fluoxetine Dextrose Fluoxetine hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
Official Title: | Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms |
Estimated Enrollment: | 206 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | April 2013 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
Sequential antidepressant pharmacotherapy with (20mg) fluoxetine, begun 8 weeks prior to and extended throughout brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.
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Drug: Fluoxetine
20mg once daily for 16 weeks
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2: Placebo Comparator
Sequential placebo medication, begun 8 weeks prior to and extended throughout brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.
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Drug: Dextrose
Once daily for 16 weeks
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Richard A. Brown, Ph.D. | (401) 455-6254 | richard_brown@brown.edu |
United States, Rhode Island | |||||
Butler Hospital | Recruiting | ||||
Providence, Rhode Island, United States, 02906 | |||||
Contact: Richard A. Brown, Ph.D. 401-455-6254 richard_brown@brown.edu | |||||
Principal Investigator: Richard A. Brown, Ph.D. | |||||
Sub-Investigator: Ana Abrantes, Ph.D. | |||||
Sub-Investigator: Ivan Miller, Ph.D. | |||||
Sub-Investigator: Raymond Niaura, Ph.D. | |||||
Sub-Investigator: Lawrence Price, M.D. | |||||
Sub-Investigator: David Strong, Ph.D. | |||||
Sub-Investigator: Kathleen Palm, Ph.D. |
Butler Hospital |
National Institute on Drug Abuse (NIDA) |
Principal Investigator: | Richard A. Brown, Ph.D. | Butler Hospital |
Website for Butler Hospital with links to research 
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Responsible Party: | Butler Hospital ( Richard A. Brown, Ph.D. ) |
Study ID Numbers: | PHI0710-002, 1 R01 DA023190 |
First Received: | December 19, 2007 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00578669 |
Health Authority: | United States: Federal Government |
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