Fluoxetine as a Quit Smoking AID for Depression Prone
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|ClinicalTrials.gov Identifier: NCT00113737|
Recruitment Status : Completed
First Posted : June 10, 2005
Last Update Posted : February 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Heart Diseases||Drug: fluoxetine Behavioral: cognitive behavioral therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Study Start Date :||February 1998|
|Actual Study Completion Date :||January 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00113737
|OverallOfficial:||Bonnie Spring||U.S. Dept/Vets Affairs Med Ctr.|