An interventional study of fluoxetine and cognitive behavioral therapy in Cardiovascular Diseases and Heart Diseases, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Completed. Open to participants aged Up to 100 Years. Per ClinicalTrials.gov, last updated 2016-02-18.
Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Not applicable, Interventional, and Prevention
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.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
Browse Cardiovascular Diseases studies →National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,117 studies on the registry; 71 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 49 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
An estimated 144 smokers with a prior history of depression and 206 smokers who lacked such a history.
No study locations are listed for this record.
This study is completed, as verified in Jun 2005. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Heart, Lung, and Blood Institute (NHLBI)