Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms

• ClinicalTrials.gov Identifier: NCT00578669
• Recruitment Status: Completed
• First Posted: December 21, 2007
• Results First Posted: October 16, 2018
• Last Update Posted: October 16, 2018
• Sponsor: Butler Hospital
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Butler Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Major Depressive Disorder; Nicotine Dependence; Depression	Drug: Fluoxetine; Drug: Dextrose	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 206 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms
• Study Start Date: April 2008
• Actual Primary Completion Date: July 2013
• Actual Study Completion Date: November 2013

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Drug: Fluoxetine; 20mg once daily for 16 weeks; Other Name: Prozac
Placebo Comparator: 2; Sequential placebo medication (dextrose), begun 8 weeks prior to and extended throughout brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.	Drug: Dextrose; Once daily for 16 weeks

Outcome Measures

Primary Outcome Measures :

1. Number of Participants Achieving Smoking Abstinence [ Time Frame: One year ]
   7-day point prevalence abstinence

Secondary Outcome Measures :

1. Self-reported Depressive Symptoms [ Time Frame: One year ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Rhode Island

Butler Hospital

Providence, Rhode Island, United States, 02906

Sponsors and Collaborators

Butler Hospital

National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Richard A. Brown, Ph.D.; Butler Hospital

More Information

Additional Information:

Website for Butler Hospital with links to research 

• Responsible Party: Butler Hospital
• ClinicalTrials.gov Identifier: NCT00578669
• Other Study ID Numbers: PHI0710-002; 1R01DA023190 ( U.S. NIH Grant/Contract )
• First Posted: December 21, 2007
• Results First Posted: October 16, 2018
• Last Update Posted: October 16, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Butler Hospital:

Smoking Cessation; Tobacco Use Cessation; Antidepressants

Additional relevant MeSH terms:

Tobacco Use Disorder; Depression; Depressive Disorder; Depressive Disorder, Major; Behavioral Symptoms; Mood Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Fluoxetine; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors