Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms

NCT ID: NCT00578669

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2013-11-30

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.

Conditions

Major Depressive Disorder; Nicotine Dependence; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Fluoxetine

Intervention Type: DRUG

20mg once daily for 16 weeks

2

Sequential placebo medication (dextrose), begun 8 weeks prior to and extended throughout brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.

Group Type: PLACEBO_COMPARATOR

Dextrose

Intervention Type: DRUG

Once daily for 16 weeks

Interventions

Fluoxetine

20mg once daily for 16 weeks

Intervention Type: DRUG

Dextrose

Once daily for 16 weeks

Intervention Type: DRUG

Other Intervention Names

Prozac

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Butler Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard A. Brown, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Butler Hospital

Locations

Butler Hospital

Providence, Rhode Island, United States

Countries

United States

Related Links

http://www.butler.org

Website for Butler Hospital with links to research

Other Identifiers

1R01DA023190

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PHI0710-002

Identifier Type: -

Identifier Source: org_study_id