Smoking While on Transdermal Nicotine Replacement Therapy: Effects on Craving and Cessation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2009-07-31

Brief Summary

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Smoking while on nicotine patches will help subjects to reduce their expired carbon monoxide levels from the levels they were before they started using the patch. Subjects will also decrease their daily consumption of cigarettes.

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Detailed Description

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Subjects who smoke while on an individually dosed tNRT will reduce their expired carbon monoxide levels from pre- to post-treatment conditions. They will also decrease their daily consumption of cigarettes.

Conditions

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Nicotine Dependence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single open-label treatment arm

Adult smokers willing to quit were treated with escalating doses of transdermal nicotine patch (Nicoderm) and brief counselling if they continued to smoke over a 9-week treatment period.

Group Type EXPERIMENTAL

Nicoderm

Intervention Type DRUG

Interventions

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Nicoderm

Intervention Type DRUG

Other Intervention Names

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NRT patch nicotine patch

Eligibility Criteria

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Inclusion Criteria

* at least 19 years of age
* male or female
* have intention to quit smoking within the next 6 months
* smoke 10 or more cigarettes per day

Exclusion Criteria

* Pregnant or not using an adequate enough method of birth control to ensure that they are not at risk of becoming pregnant
* breastfeeding
* have any generalized skin disorders
* are in an immediate post-myocardial infarction period or have life-threatening arrhythmias, have severe or worsening angina pectoris or have had a recent cerebral vascular accident
* are using additional nicotine replacement therapies or any other smoking cessation pharmacotherapy
* any clinically significant ECG abnormalities
* any known hypersensitivity to components of the transdermal system

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No