Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135746
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-08-23
Brief Title:
Examining the Effectiveness of the Nicotine Patch in Male and Female Smokers - 2
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Effects of Transdermal Nicotine on Tobacco Withdrawal and the Effects of Smoking in Men and Women
Status:
COMPLETED
Status Verified Date:
2015-10
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:
Treatment studies have demonstrated that current smoking cessation techniques are less effective for women The purpose of this study is to determine the role that gender plays on the effectiveness of nicotine replacement therapy This may lead to improved cessation interventions for all smokers particularly women
Detailed Description:
Currently about 70 percent of smokers who try to quit by using smoking cessation treatments are unsuccessful Treatment studies have demonstrated that current smoking cessation techniques are less effective for women There is no clear explanation for this difference but it may involve a differential response to nicotine replacement treatments NRTs andor smoking-related stimuli For women NRT may be less effective at suppressing withdrawal or blunting the effects of smoking during a quit attempt Women may also be more sensitive to smoking-related stimuli such as the taste sight and smell of smoke Tailoring treatment to the separate needs of subgroups such as men and women may produce better outcomes The purpose of this study is to assess the influence of gender on the effectiveness of transdermal nicotine treatment in a group of male and female smokers
Participants in this double-blind dose-comparison study will complete separate sessions in a random order
Each session will last approximately 65 hours and will correspond to a specific transdermal patch dose 0 7 14 or 21 mg Objectively verified cigarette abstinence will be required before each session Sessions will occur at least 48 hours apart to avoid carryover Cognitive behavioral subjective and physiological measures will occur during study visits Specifically the NRT dose response to tobacco suppression and cigarette blunting effects will be compared in women and men
Participants in this double-blind dose-comparison study will complete separate sessions in a random order
Each session will last approximately 65 hours and will correspond to a specific transdermal patch dose 0 7 14 or 21 mg Objectively verified cigarette abstinence will be required before each session Sessions will occur at least 48 hours apart to avoid carryover Cognitive behavioral subjective and physiological measures will occur during study visits Specifically the NRT dose response to tobacco suppression and cigarette blunting effects will be compared in women and men
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| DPMC | None | None | None |
| R01-11082-2 | None | None | None |