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Examining the Effect of the Nicotine Patch in Male and Female Smokers - 3

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00390559
Recruitment Status : Completed
First Posted : October 20, 2006
Results First Posted : July 18, 2012
Last Update Posted : July 18, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Drug Addiction Smoking Cessation Drug: nicotine transdermal system Drug: Nicotine transdermal system Other: Nicotine containing cigarette Other: Placebo 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : October 2005
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Subjective Effects [ Time Frame: 6 hours ]
    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").


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00390559


Locations
United States, Virginia
Virginia Commonwealth University - Clinical Behavioral Pharmacology Laboratory
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Thomas E Eissenberg, PhD Virginia Commonwealth University Department of Psychology, Institute for Drug and Alcohol Studies
More Information

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00390559     History of Changes
Other Study ID Numbers: NIDA-11082-3
R01DA011082 ( U.S. NIH Grant/Contract )
R01-11082-3 DPMC
First Posted: October 20, 2006    Key Record Dates
Results First Posted: July 18, 2012
Last Update Posted: July 18, 2012
Last Verified: July 2012

Keywords provided by Virginia Commonwealth University:
Nicotine Replacement Therapy
Tobacco Smoking
Smoking stimuli
Gender

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action