Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390559
Status:
COMPLETED
Last Update Posted:
2012-07-18
First Post:
2006-10-18
Brief Title:
Examining the Effect of the Nicotine Patch in Male and Female Smokers - 3
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
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 eg 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:
Currentlyabout 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 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 ie 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 65 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 participants 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 65 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 participants 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:
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 |
|---|---|---|---|
| R01-11082-3 DPMC | US NIH GrantContract | None | httpsreporternihgovquickSearchR01DA011082 |
| R01DA011082 | NIH | None | None |