Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-26 @ 7:38 PM
Study NCT ID:
NCT00390559
Status:
COMPLETED
Last Update Posted:
2012-07-18
First Post:
2006-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Examining the Effect of the Nicotine Patch in Male and Female Smokers - 3
Sponsor:
Virginia Commonwealth University
Organization:
Study Overview
Official Title:
Effects of Transdermal Nicotine on Tobacco Withdrawal and the Effects of Smoking-related Stimuli in Men and Women
Status:
COMPLETED
Status Verified Date:
2012-07
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 in the effectiveness of nicotine replacement therapy. In addition, the purpose of this study is to determine whether men and women differ in their response to smoking-related stimuli (e.g., taste or smell of a lit cigarette). Conclusions drawn from this study may help to improve 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) and/or 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, suc has the taste, sight, or smell of cigarette smoke. Tailoring treatments to the separate needs of smoker subgroups , such as men and women, my produce better cessation outcomes. The purpose of this study is to assess whether men and women differ in the their response to NRT (i.e., transdermal nicotine) and smoking-related stimuli.
Participants in this double-blind, dose-comparison study will complete separate sessions in random order.
Each session will last approximately 6.5 hours and will correspond to a transdermal patch dose (0 or 21mg) and cigarette type (denicotinized and nicotinized). Objectively verified cigarette abstinence will be required before each session. Sessions will occur at least 48 hours apart to avoid carryover. At the beginning of each session a patch will be placed on the participant's back and at 4, 5, and 6 hours after patch application the participant will smoke a cigarette (all identifying marking on the cigarette will be covered for blinding purposes). Physiological, subjective, cognitive, and smoking behavior outcomes will be collected during study visits.
Participants in this double-blind, dose-comparison study will complete separate sessions in random order.
Each session will last approximately 6.5 hours and will correspond to a transdermal patch dose (0 or 21mg) and cigarette type (denicotinized and nicotinized). Objectively verified cigarette abstinence will be required before each session. Sessions will occur at least 48 hours apart to avoid carryover. At the beginning of each session a patch will be placed on the participant's back and at 4, 5, and 6 hours after patch application the participant will smoke a cigarette (all identifying marking on the cigarette will be covered for blinding purposes). Physiological, subjective, cognitive, and smoking behavior outcomes will be collected during study visits.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01DA011082 | NIH | None | https://reporter.nih.gov/quic… | View |
| R01-11082-3 DPMC | None | None | View |