Ignite Creation Date:
2024-05-06 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03029923
Status:
WITHDRAWN
Last Update Posted:
2017-08-29
First Post:
2017-01-20
Brief Title:
Integrated Smoking Cessation and Mood Management for ACS Patients
Sponsor:
The Miriam Hospital
Organization:
The Miriam Hospital
Study Overview
Official Title:
Integrated Smoking Cessation and Mood Management for ACS Patients PACES Phase IV Vanguard R56 Trial
Status:
WITHDRAWN
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding for this pilot transitioned into funding for a fully powered study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PACES
Brief Summary:
Quitting smoking following acute coronary syndrome can reduce mortality up to 50 However depression and smoking are highly co-morbid and depressed mood may interfere with cessation and independently predicts mortality Thus a single integrated treatment for both smoking and depression could be highly effective in reducing post-acute coronary syndrome mortality Behavioral Activation BA is a well established treatment for depression and has recently shown promise as a treatment for smoking cessation The investigators systematically developed an intervention integrating gold standard smoking cessation counseling with existing BA based mood management techniques for post-ACS smokers Behavioral Activation Treatment for Cardiac Smokers BAT-CS
Objective For this R56 the investigators will conduct a vanguard trial to pilot all methods materials and systems for the later fully powered BAT-CS vs attention control trial The investigators will enroll up to 36 smokers with ACS and randomize them to 12 weeks of BAT-CS or an attention control Health and Wellness Education Both groups will be offered the nicotine patch if medically safe
Objective For this R56 the investigators will conduct a vanguard trial to pilot all methods materials and systems for the later fully powered BAT-CS vs attention control trial The investigators will enroll up to 36 smokers with ACS and randomize them to 12 weeks of BAT-CS or an attention control Health and Wellness Education Both groups will be offered the nicotine patch if medically safe
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R56HL131711-01A1 | NIH | None | httpsreporternihgovquickSearchR56HL131711-01A1 |