Ignite Creation Date:
2024-05-06 @ 7:04 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02460900
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2015-05-29
Brief Title:
Optimizing Smoking Cessation for People With HIVAIDS Who Smoke
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Optimizing Smoking Cessation for People With HIVAIDS Who Smoke
Status:
COMPLETED
Status Verified Date:
2023-07
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 single greatest health behavior change that could improve cardiovascular morbidity and associated mortality is to assist people living with HIVAIDS who smoke to quit The investigators will use a factorial design to evaluate the most promising behavioral and pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among people living with HIVAIDS who smoke Results of this study will provide crucial real world evidence of the best way for healthcare providers to help smokers living with HIVAIDS quit smoking
Detailed Description:
The study used a factorial design to randomize participants into 4 conditions 1 Varenicline 12 weeks Positively Smoke Free PSF 8 weeks 2 Varenicline 12 weeks Standard of Care brief advice to quit 3 Placebo 12 weeks Positively Smoke Free 8 weeks and 4 Placebo 12 weeks Standard of Care The primary outcome was the 7-day point prevalence abstinence PPA 10mm at 36 weeks
The specific aims of our proposal are
Primary Aim 1 Compare varenicline to placebo on rates of 7-day point prevalence abstinence PPA at 36 weeks in smokers with HIVAIDS We hypothesize that rates of smoking abstinence at week 36 will be higher in those treated with varenicline compared to placebo
Primary Aim 2 Compare Positively Smoke Free to low intensity brief counseling on rates of 7-day PPA at 36 weeks in smokers with HIVAIDS We hypothesize that rates of smoking abstinence at week 36 will be higher in those treated with Positively Smoke Free compared to brief counseling
Primary Aim 3 Compare Positively Smoke Free varenicline to the other two study conditions outlined above on rates of 7-day PPA in smokers with HIVAIDS at 36 weeks We hypothesize the effect of PSF with varenicline is greater than the effect of PSF or varenicline alone
Exporatory Aim Explore the effect of successful cessationsmoking abstinence on levels of cardiac specific biomarkers nicotine biomarkers generalized markers of inflammation lipids coagulation and monocytemacrophage activation
The specific aims of our proposal are
Primary Aim 1 Compare varenicline to placebo on rates of 7-day point prevalence abstinence PPA at 36 weeks in smokers with HIVAIDS We hypothesize that rates of smoking abstinence at week 36 will be higher in those treated with varenicline compared to placebo
Primary Aim 2 Compare Positively Smoke Free to low intensity brief counseling on rates of 7-day PPA at 36 weeks in smokers with HIVAIDS We hypothesize that rates of smoking abstinence at week 36 will be higher in those treated with Positively Smoke Free compared to brief counseling
Primary Aim 3 Compare Positively Smoke Free varenicline to the other two study conditions outlined above on rates of 7-day PPA in smokers with HIVAIDS at 36 weeks We hypothesize the effect of PSF with varenicline is greater than the effect of PSF or varenicline alone
Exporatory Aim Explore the effect of successful cessationsmoking abstinence on levels of cardiac specific biomarkers nicotine biomarkers generalized markers of inflammation lipids coagulation and monocytemacrophage activation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| R01HL136253 | NIH | None | httpsreporternihgovquickSearchR01HL136253 |