Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00018174
Status:
COMPLETED
Last Update Posted:
2009-03-02
First Post:
2001-07-03
Brief Title:
Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers
Status:
COMPLETED
Status Verified Date:
2009-02
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:
This project is a treatment-matching study to test whether adding antidepressant pharmacotherapy to behavioral cessation treatment improves the depression-prone smokers ability to quit while not undermining cessation goals for the smoker who lacks a history of depression The study target is to randomize 120 smokers with a prior history of depression and 120 smokers who lack such a history to a double-blind treatment with either 60 mg fluoxetine or placebo while they undergo cognitive behavioral treatment to quit smoking
Detailed Description:
The aim of this research is to examine whether adding antidepressant pharmacotherapy to behavioral cessation treatment improves the depression-prone smokers ability to quit while not undermining cessation for the smoker who lacks a history of depression by randomizing smokers both with and without such a history to double-blind treatment with either 60 mg fluoxetine or placebo The primary Depressive Episode Hypothesis states that the stress of quitting smoking and the biological challenge of nicotine withdrawal trigger a depressive episode in vulnerable individuals To the extent that episode onset can be prevented by prophylactic administration of antidepressant pharmacotherapy smokers with a history of depression will show significantly higher abstinence rates when treated with fluoxetine than placebo whereas no drug effect will be evident for history negative smokers who lack the depressive diathesis An alternative generalized withdrawal hypothesis construes post-cessation dysphoria as one general manifestation of a nicotine withdrawal syndrome that occurs independently of depressive vulnerability and predicts that fluoxetine as compared to placebo will uniformly improve cessation outcomes regardless of whether smokers possess the diathesis for depression Over period of four years the study hopes to randomize 120 smokers with a history of depression and 120 smokers who lack such a history to double-blind treatment with either 60 mg fluoxetine or placebo while they undergo group cognitive behavioral treatment to quit smoking To allow plasma drug levels to stabilize before quitting smoking drug or placebo treatment begins 3 weeks before quitting smoking and continues for an additional 8 weeks following the quit date Participants will be followed up monthly for 4 months after the end of treatment in order to assess the main study outcome abstinence from smoking 6 months after the quit date
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None