Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Butler Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Butler Hospital
ClinicalTrials.gov Identifier:
NCT00578669
First received: December 19, 2007
Last updated: June 11, 2013
Last verified: March 2012
  Purpose

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 Intervention Phase
Major Depressive Disorder
Nicotine Dependence
Depression
Drug: Fluoxetine
Drug: Dextrose
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms

Resource links provided by NLM:


Further study details as provided by Butler Hospital:

Primary Outcome Measures:
  • Self-reported smoking abstinence via Timeline Followback (TLFB) [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Biochemically verified smoking abstinence via carbon monoxide and saliva cotinine [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-reported depressive symptoms [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Self-reported nicotine withdrawal symptoms [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 206
Study Start Date: April 2008
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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, 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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578669

Locations
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
Investigators
Principal Investigator: Richard A. Brown, Ph.D. Butler Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT00578669     History of Changes
Other Study ID Numbers: PHI0710-002, 1 R01 DA023190
Study First Received: December 19, 2007
Last Updated: June 11, 2013
Health Authority: United States: Federal Government

Keywords provided by Butler Hospital:
Smoking Cessation
Tobacco Use Cessation
Antidepressants

Additional relevant MeSH terms:
Depression
Depressive Disorder
Tobacco Use Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Substance-Related Disorders
Antidepressive Agents
Fluoxetine
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on July 22, 2014