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

This study has been completed.
Sponsor:
Information provided by:
Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT00289653
First received: February 8, 2006
Last updated: May 9, 2009
Last verified: May 2009
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Smoking While on Transdermal Nicotine Replacement Therapy: Effects on Craving and Cessation

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier: NCT00289653     History of Changes
Other Study ID Numbers: 205/2005
Study First Received: February 8, 2006
Last Updated: May 9, 2009
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

Additional relevant MeSH terms:
Tobacco Use Disorder
Smoking
Substance-Related Disorders
Mental Disorders
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013