Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms
| Status: | Completed |
|---|---|
| Conditions: | Depression, Smoking Cessation, Major Depression Disorder (MDD), Tobacco Consumers |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/18/2018 |
| Start Date: | April 2008 |
| End Date: | November 2013 |
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.
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.
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.
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
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Butler Hospital Founded in 1844, Butler Hospital is the state's only non-profit, free-standing psychiatric hospital...
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