Smoking While on Transdermal Nicotine Replacement Therapy: Effects on Craving and Cessation - Full Text View

Purpose

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, change how they smoke the cigarette, and will show reduced reactivity to smoking-related cues and reduced craving.

Condition	Intervention
Nicotine Dependence	Drug: Nicoderm

MedlinePlus related topics:

Mental Health Smoking

Drug Information available for:

Nicotine polacrilex Nicotine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:

carbon monoxide levels

Secondary Outcome Measures:

craving
cessation

Estimated Enrollment:	60
Study Start Date:	September 2005
Estimated Study Completion Date:	June 2006

Detailed 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, change their smoking topography, and will show reduced reactivity to smoking-related cues and reduced craving.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289653

Locations


Canada, Ontario
	Centre for Addiction and Mental Health
	Toronto, Ontario, Canada, M5S 2S1

Sponsors and Collaborators

Centre for Addiction and Mental Health

Investigators


Principal Investigator:	Peter Selby, MD	Centre for Addiction and Mental Health

More Information

Study ID Numbers:	205/2005
First Received:	February 8, 2006
Last Updated:	January 31, 2007
ClinicalTrials.gov Identifier:	NCT00289653
Health Authority:	Canada: Health Canada

Keywords provided by Centre for Addiction and Mental Health:

nicotine dependence,

transdermal nicotine patch,

smoking while receiving nicotine replacement,

comorbidities

Study placed in the following topic categories:

Nicotine polacrilex

Smoking

Nicotine

Mental Disorders

Tobacco Use Disorder

Substance-Related Disorders

Disorders of Environmental Origin

Additional relevant MeSH terms:

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Cholinergic Agonists

Autonomic Agents

Nicotinic Agonists

Physiological Effects of Drugs

Ganglionic Stimulants

Peripheral Nervous System Agents

Cholinergic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 23, 2008

Sponsored by:	Centre for Addiction and Mental Health
Information provided by:	Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:	NCT00289653