Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113737
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2005-06-09
Brief Title:
Fluoxetine as a Quit Smoking AID for Depression Prone
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To test whether adding fluoxetine pharmacotherapy to behavioral cessation treatment improves the depression-prone smokers 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 smokers 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 drugplacebo 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 fluoxetines 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
The research was a treatment-matching study to test whether adding fluoxetine pharmacotherapy to behavioral cessation treatment improved the depression-prone smokers 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 drugplacebo 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 fluoxetines 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL059348 | NIH | None | httpsreporternihgovquickSearchR01HL059348 |