Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04525755
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2020-08-19
Brief Title:
STARS Smoking Treatment And Remote Sampling Study
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
A Translational Randomized Clinical Trial of Varenicline Sampling to Promote Smoking Cessation and Scalable Treatment Dissemination
Status:
RECRUITING
Status Verified Date:
2024-03
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 is a research study to find out if a smoking cessation medications either varenicline or nicotine replacement products patches or lozenges are effective when given to smokers remotely as a one-time sample
Participants will either receive a sample of varenicline nicotine patches and lozenges or neither This will be decided randomly Participants have a 50chance of receiving varenicline a 25 chance of receiving nicotine products and a 25 chance of receiving neither If the participant is assigned to a group that receives free samples they will be mailed to them free of charge There is no requirement to use them and it is completely up to the participants There is also no requirement to quit in this study
The study lasts for six months and will involve six total surveys In addition investigators ask that participants complete daily diaries about 1 minute each for the first 4 weeks of the study Both varenicline and nicotine replacement products are well-established medications that help smokers quit
Participants will either receive a sample of varenicline nicotine patches and lozenges or neither This will be decided randomly Participants have a 50chance of receiving varenicline a 25 chance of receiving nicotine products and a 25 chance of receiving neither If the participant is assigned to a group that receives free samples they will be mailed to them free of charge There is no requirement to use them and it is completely up to the participants There is also no requirement to quit in this study
The study lasts for six months and will involve six total surveys In addition investigators ask that participants complete daily diaries about 1 minute each for the first 4 weeks of the study Both varenicline and nicotine replacement products are well-established medications that help smokers quit
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None