Full Text View
Tabular View
No Study Results Posted
Related Studies
Fluoxetine as a Quit Smoking AID for Depression Prone
This study has been completed.
Study NCT00113737   Information provided by National Heart, Lung, and Blood Institute (NHLBI)
First Received: June 9, 2005   Last Updated: June 23, 2005   History of Changes

June 9, 2005
June 23, 2005
February 1998
 
 
 
Complete list of historical versions of study NCT00113737 on ClinicalTrials.gov Archive Site
 
 
 
Fluoxetine as a Quit Smoking AID for Depression Prone
 

To test whether adding fluoxetine pharmacotherapy to behavioral cessation treatment improves the depression-prone smoker’s ability to quit.

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.

 
Interventional
Prevention, Double-Blind, Placebo Control
  • Cardiovascular Diseases
  • Heart Diseases
  • Drug: fluoxetine
  • Behavioral: cognitive behavioral therapy
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
January 2002
 

An estimated 144 smokers with a prior history of depression and 206 smokers who lacked such a history.

Both
 
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00113737
 
183
National Heart, Lung, and Blood Institute (NHLBI)
 
Investigator: Bonnie Spring U.S. Dept/Vets Affairs Med Ctr.
National Heart, Lung, and Blood Institute (NHLBI)
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP