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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00113737 |
To test whether adding fluoxetine pharmacotherapy to behavioral cessation treatment improves the depression-prone smokers ability to quit.
Condition | Intervention |
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Cardiovascular Diseases Heart Diseases |
Drug: fluoxetine Behavioral: cognitive behavioral therapy |
Study Type: | Interventional |
Study Design: | Prevention, Double-Blind, Placebo Control |
Study Start Date: | February 1998 |
Estimated Study Completion Date: | January 2002 |
DESIGN NARRATIVE:
The research was a treatment-matching study to test whether adding fluoxetine pharmacotherapy to behavioral cessation treatment improved the depression-prone smoker's ability to quit. The investigators randomized 144 smokers with a prior history of depression and 206 smokers who lack such a history to a double-blind treatment with either 60 mg fluoxetine or placebo, while they underwent cognitive behavioral treatment to quit smoking. The main study outcome was biologically verified abstinence 6 months after treatment. The administration of placebo and fluoxetine began 3 weeks before the quit smoke date and continued for 2 months post-quit date (totaling 11 weeks on drug/placebo). Cognitive behavioral treatment were weekly before quitting and biweekly after quitting. There were monthly follow-up evaluations for six months after the quit date. The research tested both the Selective Benefit Hypothesis and the Generalized Benefit Hypothesis of fluoxetine's effects. The hypothesis of the mechanism of action was that the drug diminished compulsive smoking behavior, obsessional cigarette craving, and nicotine withdrawal dysphoria that occurred independently of depressive vulnerability.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
An estimated 144 smokers with a prior history of depression and 206 smokers who lacked such a history.
Study ID Numbers: | 183 |
Study First Received: | June 9, 2005 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00113737 |
Health Authority: | United States: Federal Government |
Fluoxetine Smoking Depression |
Heart Diseases Depressive Disorder Serotonin |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors Pharmacologic Actions |
Serotonin Agents Therapeutic Uses Cardiovascular Diseases Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |