Clinical trial NCT00578669: Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms
Official title: Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Nicotine Dependence
Depression
Keywords: Smoking Cessation
Tobacco Use Cessation
Antidepressants
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2007-12-21
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Achieving Smoking Abstinence
timeFrame: One year
Secondary outcomes:
measure: Self-reported Depressive Symptoms
timeFrame: One year
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Richard A. Brown, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: