Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00296647
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
2006-02-24
Brief Title:
Smoking Cessation Intervention Effectiveness in Primary Care
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Tobacco Dependence Treatment and Outcomes Pharmacotherapies Effectiveness in Primary Care
Status:
COMPLETED
Status Verified Date:
2015-10
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:
The information gathered in this study may help to develop more effective ways to help people quit smoking and stay quit in the future
Detailed Description:
Randomized clinical trials may not accurately reflect the public health benefit of tobacco dependence pharmacotherapies when used in real-world clinical settings due to differences in patient selection motivation and adherence To have a positive public health impact a treatment must be accessible and acceptable to a broad range of smokers and effective under normal use conditions The proposed project will assess primary care patients willingness to use cessation treatment and will determine the relative effectiveness of five cessation pharmacotherapies This research builds on a primary care clinic-based recruitment strategy that was highly successful in a previous study In the proposed research 1320 primary care patients presenting for a regular outpatient visit will be recruited by medical assistants to participate in a free smoking cessation program and will be randomly assigned to one of five active pharmacotherapies patch lozenge bupropion patchlozenge and bupropionlozenge n 264condition Interested participants who pass medical screening will pick up their medications at clinic pharmacies and will receive proactive telephone counseling from the Wisconsin Tobacco Quit Line Assessment will be limited to preserve the generalizability of the findings but select individual differences will be assessed pre-quit to validate algorithms from Project 1 Efficacy designed to optimize pharmacotherapy selection for smokers based on gender level of dependence and other factors Smoking behavior will be assessed at six months and one year post-quit so that abstinence rates across pharmacotherapy conditions can be compared The cost of incorporating tobacco dependence treatment into primary care will also be estimated
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50DA019706 | NIH | None | httpsreporternihgovquickSearchP50DA019706 |