Examining the Effect of the Nicotine Patch in Male and Female Smokers - 3
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Drug Addiction Smoking Cessation |
Drug: nicotine transdermal system Drug: Nicotine transdermal system Other: Nicotine containing cigarette Other: Placebo cigarette |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Effects of Transdermal Nicotine on Tobacco Withdrawal and the Effects of Smoking-related Stimuli in Men and Women |
- Subjective Effects [ Time Frame: 6 hours ] [ Designated as safety issue: No ]The full scale name is the "Urge to smoke" visual analog scale (VAS). It measures self-reported "urge to smoke". As with any VAS a word or phrase (in this case, "Urge to Smoke" is centered over a horizontal line anchored on the left by "not at all" and on the right by "extremely." In this study, participants used a mouse to produce a vertical mark on the horizontal line, and the score was the distance of the mark from the left anchor expressed as a percentage of total line length. Thus, the minimum was 0 ("not at all") and the maximum score was 100 ("extremely").
| Enrollment: | 80 |
| Study Start Date: | October 2005 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ActiveP/ActiveC
21 mg patch/Nicotine-containing cigarette
|
Drug: nicotine transdermal system
21 mg nicotine transdermal system
Other Name: Nicoderm CQ
Other: Nicotine containing cigarette
Nicotine containing cigarette
|
|
Experimental: PlaceboP/ActiveC
0 mg patch/nicotine-containing cigarette
|
Drug: Nicotine transdermal system
Placebo nicotine patch
Other: Nicotine containing cigarette
Nicotine containing cigarette
|
|
Experimental: Active P/PlaceboC
21 mg patch/no nicotine cigarette
|
Drug: nicotine transdermal system
21 mg nicotine transdermal system
Other Name: Nicoderm CQ
Other: Placebo cigarette
Non nicotine containing cigarette
|
|
Experimental: PlaceboP/PlaceboC
0 mg patch/no nicotine cigarette
|
Drug: Nicotine transdermal system
Placebo nicotine patch
Other: Placebo cigarette
Non nicotine containing cigarette
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria include, but are not limited to:
18-50 years of age Smokes 15 cigarettes/day for at least 2 years Healthy (as determined by a brief study physical with medical doctor) Displays understanding of cognitive tasks.
Exclusion Criteria include, but are not limited to:
History of chronic health problems or psychiatric conditions History of cardiovascular disease, low or high blood pressure, seizures, head injuries requiring hospital care, peptic ulcer, or diabetes Pregnancy (tested by urinalysis) Scores greater than 17 on the Beck Depression Inventory Lack of a high school degree or GED
Contacts and Locations| United States, Virginia | |
| Virginia Commonwealth University - Clinical Behavioral Pharmacology Laboratory | |
| Richmond, Virginia, United States, 23298 | |
| Principal Investigator: | Thomas E Eissenberg, PhD | Virginia Commonwealth University Department of Psychology, Institute for Drug and Alcohol Studies |
More Information
No publications provided
| Responsible Party: | Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT00390559 History of Changes |
| Other Study ID Numbers: | NIDA-11082-3, R01DA011082, R01-11082-3 DPMC |
| Study First Received: | October 18, 2006 |
| Results First Received: | November 10, 2011 |
| Last Updated: | July 6, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Virginia Commonwealth University:
|
Nicotine Replacement Therapy Tobacco Smoking Smoking stimuli Gender |
Additional relevant MeSH terms:
|
Smoking Substance-Related Disorders Behavior, Addictive Habits Mental Disorders Compulsive Behavior Impulsive Behavior Nicotine Nicotine polacrilex Ganglionic Stimulants Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013