Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms

Depression Clinical Trial

Official title:

Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00578669
• Other study ID #: PHI0710-002
• Secondary ID: 1R01DA023190
• Status: Completed
• Phase: Phase 3
• Start date: April 2008
• Est. completion date: November 2013

Study information

• Verified date: September 2018
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: November 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Drug:
• Fluoxetine
20mg once daily for 16 weeks
• Dextrose
Once daily for 16 weeks

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Achieving Smoking Abstinence	7-day point prevalence abstinence	One year
Secondary	Self-reported Depressive Symptoms	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.	One year

External Links

•   Website for Butler Hospital with links to research