Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373679
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-04-05
Brief Title:
Switch or Quit R01
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Non-cigarette Tobacco Products as Harm Reduction Tools in Smokers Who Failed to Quit With Traditional Methods
Status:
RECRUITING
Status Verified Date:
2024-08
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 study evaluates whether non-cigarette tobacco products e-cigarettes can help smokers quit smoking as compared to traditional quit methods nicotine replacement therapy or vareniclineChantix Participants in this study will be randomly assigned to one of two groups then will have a choice between the offered products of that group Participants in the e-cigarette group will have a choice of e-cigarette brand and flavor Participants in the medication group will have choice between nicotine replacement therapy patches and lozenges or varenicline also known as Chantix Participation will last 6 months and will include weekly phone calls for the initial 7-weeks plus a 11-week phone call and a 6-month follow-up visit Participants will also complete electronic daily diaries during the first 7-weeks
Detailed Description:
Even though e-cigarettes have risen in prevalence over the last decade data on the use of these products as harm reduction tools for smokers who try to switch completely is lacking
These data are urgently needed for several reasons
1 Clinicians cannot provide clear guidance to smokers who may be interested in switching Questions from medical patients about e-cigarettes are on the rise and data show that medical providers are providing mixed messages about the safety and utility of e-cigarettes with some physicians discouraging their use and some recommending them as cessation aids
2 Public health organizations are also providing mixed messages about the health risks of non-cigarette tobacco products-with some not recommending their use at all The American Cancer Society American Lung Association and some acknowledging that complete switching to e-cigarettes would reduce health risks compared to continued smoking but not recommending the use of these products over traditional methods Centers for Disease Control Food and Drug Administration
3 In the absence of clear messaging about non-cigarette products smokers who fail with traditional methods are continuing to smoke cigarettes the most harmful tobacco product available
The reviews underscore the need for additional data on this topic especially data comparing the products to pharmacotherapy The goal of the proposed study is to provide one of the first well-designed randomized controlled trials that addresses whether alternative tobacco products e-cigarettes have the potential to serve as harm reduction tools in a critical population-smokers who have tried to quit smoking using FDA-approved pharmacotherapy and failed to do so
These data are urgently needed for several reasons
1 Clinicians cannot provide clear guidance to smokers who may be interested in switching Questions from medical patients about e-cigarettes are on the rise and data show that medical providers are providing mixed messages about the safety and utility of e-cigarettes with some physicians discouraging their use and some recommending them as cessation aids
2 Public health organizations are also providing mixed messages about the health risks of non-cigarette tobacco products-with some not recommending their use at all The American Cancer Society American Lung Association and some acknowledging that complete switching to e-cigarettes would reduce health risks compared to continued smoking but not recommending the use of these products over traditional methods Centers for Disease Control Food and Drug Administration
3 In the absence of clear messaging about non-cigarette products smokers who fail with traditional methods are continuing to smoke cigarettes the most harmful tobacco product available
The reviews underscore the need for additional data on this topic especially data comparing the products to pharmacotherapy The goal of the proposed study is to provide one of the first well-designed randomized controlled trials that addresses whether alternative tobacco products e-cigarettes have the potential to serve as harm reduction tools in a critical population-smokers who have tried to quit smoking using FDA-approved pharmacotherapy and failed to do so
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01DA056445-01A1 | NIH | None | httpsreporternihgovquickSearch1R01DA056445-01A1 |