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

NCT ID: NCT00390559

Last Updated: 2012-07-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-03-31

Brief Summary

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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

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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.

Conditions

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Drug Addiction Smoking Cessation

Keywords

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Nicotine Replacement Therapy Tobacco Smoking Smoking stimuli Gender

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ActiveP/ActiveC

21 mg patch/Nicotine-containing cigarette

Group Type EXPERIMENTAL

nicotine transdermal system

Intervention Type DRUG

21 mg nicotine transdermal system

Nicotine containing cigarette

Intervention Type OTHER

Nicotine containing cigarette

PlaceboP/ActiveC

0 mg patch/nicotine-containing cigarette

Group Type EXPERIMENTAL

Nicotine transdermal system

Intervention Type DRUG

Placebo nicotine patch

Nicotine containing cigarette

Intervention Type OTHER

Nicotine containing cigarette

Active P/PlaceboC

21 mg patch/no nicotine cigarette

Group Type EXPERIMENTAL

nicotine transdermal system

Intervention Type DRUG

21 mg nicotine transdermal system

Placebo cigarette

Intervention Type OTHER

Non nicotine containing cigarette

PlaceboP/PlaceboC

0 mg patch/no nicotine cigarette

Group Type EXPERIMENTAL

Nicotine transdermal system

Intervention Type DRUG

Placebo nicotine patch

Placebo cigarette

Intervention Type OTHER

Non nicotine containing cigarette

Interventions

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nicotine transdermal system

21 mg nicotine transdermal system

Intervention Type DRUG

Nicotine transdermal system

Placebo nicotine patch

Intervention Type DRUG

Nicotine containing cigarette

Nicotine containing cigarette

Intervention Type OTHER

Placebo cigarette

Non nicotine containing cigarette

Intervention Type OTHER

Other Intervention Names

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Nicoderm CQ

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas E Eissenberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University Department of Psychology, Institute for Drug and Alcohol Studies

Locations

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Virginia Commonwealth University - Clinical Behavioral Pharmacology Laboratory

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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R01DA011082

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01-11082-3 DPMC

Identifier Type: -

Identifier Source: secondary_id

NIDA-11082-3

Identifier Type: -

Identifier Source: org_study_id