Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00218140
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-09-16
Brief Title:
Effectiveness of the Nicotine Patch in Suppressing Nicotine Withdrawal Symptoms in Women Versus Men - 1
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Effects of Nicotine Patch in Men and Women
Status:
COMPLETED
Status Verified Date:
2016-10
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:
Women typically have a more difficult time quitting smoking than men Little research has been done to understand the differences between men and women that may cause this distinction This study will assess whether the reduced effectiveness of nicotine replacement therapy in women is caused by gender differences in the withdrawal suppression induced by nicotine replacement therapy
Detailed Description:
Smoking can cause a variety of cancers cardiovascular disorders and other health problems Quitting smoking greatly decreases ones risk for these problems Studies have shown however that quitting smoking is more difficult for women than men Despite that knowledge little research has been done to try to understand the mechanistic differences between men and women that may cause this distinction This study will assess whether the reduced effectiveness of nicotine replacement therapy in women is caused by physical and psychological gender differences in the withdrawal suppression induced by nicotine replacement therapy
Participants in this double-blind study will attend 4 treatment sessions each approximately 65 hours long and each corresponding to one of four transdermal nicotine replacement patch doses 0 7 21 or 42 mg Sessions will be separated by at least 48 hours to avoid carryover effects Immediately following arrival at each session participants expired air carbon monoxide CO levels will be measured to verify that the participant has not smoked for at least 8 hours prior to the visit If the CO level meets the necessary criteria to proceed a baseline blood sample will be obtained followed by additional blood samples every 30 minutes Baseline nicotine withdrawal levels will be assessed using questionnaires Computerized recordings of physiological responses will also commence and will continue throughout the session These response measures will include heart rate percent oxygen saturation skin temperature systolic and diastolic blood pressure and mean arterial pressure Upon completion of baseline measures participants will receive a randomly assigned dose of nicotine replacement therapy in the form of three patches placed on the participants back The patches will be removed after 6 hours and the participant will be assessed for any residual effects from the medication
Participants in this double-blind study will attend 4 treatment sessions each approximately 65 hours long and each corresponding to one of four transdermal nicotine replacement patch doses 0 7 21 or 42 mg Sessions will be separated by at least 48 hours to avoid carryover effects Immediately following arrival at each session participants expired air carbon monoxide CO levels will be measured to verify that the participant has not smoked for at least 8 hours prior to the visit If the CO level meets the necessary criteria to proceed a baseline blood sample will be obtained followed by additional blood samples every 30 minutes Baseline nicotine withdrawal levels will be assessed using questionnaires Computerized recordings of physiological responses will also commence and will continue throughout the session These response measures will include heart rate percent oxygen saturation skin temperature systolic and diastolic blood pressure and mean arterial pressure Upon completion of baseline measures participants will receive a randomly assigned dose of nicotine replacement therapy in the form of three patches placed on the participants back The patches will be removed after 6 hours and the participant will be assessed for any residual effects from the medication
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DPMC | None | None | None |
| R01-11082-1 | None | None | None |