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Fluoxetine as a Quit Smoking AID for Depression Prone

This study has been completed.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI) Identifier:
First received: June 9, 2005
Last updated: February 17, 2016
Last verified: June 2005
To test whether adding fluoxetine pharmacotherapy to behavioral cessation treatment improves the depression-prone smoker's ability to quit.

Condition Intervention
Cardiovascular Diseases
Heart Diseases
Drug: fluoxetine
Behavioral: cognitive behavioral therapy

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: February 1998
Study Completion Date: January 2002
Detailed Description:


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.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.


Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
An estimated 144 smokers with a prior history of depression and 206 smokers who lacked such a history.
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Please refer to this study by its identifier: NCT00113737

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
OverallOfficial: Bonnie Spring U.S. Dept/Vets Affairs Med Ctr.
  More Information

Publications: Identifier: NCT00113737     History of Changes
Other Study ID Numbers: 183
R01HL059348 ( US NIH Grant/Contract Award Number )
Study First Received: June 9, 2005
Last Updated: February 17, 2016

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
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 processed this record on April 27, 2017