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

Center for Addiction and Mental Health (CAMH)

Status: Completed

Conditions: Nicotine Dependence

Treatments: Drug: Nicoderm

Study type: Interventional

Funder types: Other

Identifiers

NCT00289653

205/2005

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 23 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

single open-label treatment arm

Experimental group

Description:

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.

Treatment:

Drug: Nicoderm