Skip to content

Fluoxetine as a Quit Smoking AID for Depression Prone

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00113737
Enrollment
Unknown
Registered
2005-06-10
Start date
1998-02-28
Completion date
2002-01-31
Last updated
2016-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Heart Diseases

Brief summary

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

Detailed description

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.

Interventions

DRUGfluoxetine
BEHAVIORALcognitive behavioral therapy

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
Lead SponsorNIH

Study design

Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
No minimum to 100 Years
Healthy volunteers
No

Inclusion criteria

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026