Ignite Creation Date:
2024-05-06 @ 3:07 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02202499
Status:
COMPLETED
Last Update Posted:
2020-11-27
First Post:
2014-07-22
Brief Title:
Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence Intervention Development and Feasibility Trial
Status:
COMPLETED
Status Verified Date:
2020-11
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 purpose of this Pilot feasibility study is to find out the effect of different behavioral treatments along with different duration of a drug called varenicline on smoking behavior and quitting smoking Varenicline also known as Chantix is an FDA-approved medication that has been shown to help people quit smoking
Detailed Description:
Following the initial telephone screening eligible participants will be scheduled for a screening evaluation session
Following the screening evaluation participants who pass the medical screening and meet all other inclusion criteria will be scheduled for their first assessment and then randomized to receive standard varenicline SV extended varenicline EV or extended varenicline plus facilitated extinction EV FE The randomization list will be generated by the study statistician It will be stratified by gender and will employ a variable block randomization that will guarantee that the arms are balanced when a given block is filled
Following the screening evaluation participants who pass the medical screening and meet all other inclusion criteria will be scheduled for their first assessment and then randomized to receive standard varenicline SV extended varenicline EV or extended varenicline plus facilitated extinction EV FE The randomization list will be generated by the study statistician It will be stratified by gender and will employ a variable block randomization that will guarantee that the arms are balanced when a given block is filled
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