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

February 8, 2006
May 9, 2009
September 2005
Not Provided
carbon monoxide levels
Same as current
Complete list of historical versions of study NCT00289653 on ClinicalTrials.gov Archive Site
  • craving
  • cessation
Same as current
Not Provided
Not Provided
 
Smoking While on Transdermal Nicotine Replacement Therapy: Effects on Craving and Cessation
Smoking While on Transdermal Nicotine Replacement Therapy: Effects on Craving and Cessation

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Nicotine Dependence
Drug: Nicoderm
Not Provided
Selby P, Andriash K, Zawertailo L, Persad D, Zack M, Busto UE. Escalating doses of transdermal nicotine in heavy smokers: effects on smoking behavior and craving. J Clin Psychopharmacol. 2013 Oct;33(5):667-74. doi: 10.1097/JCP.0b013e31829a829d.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2006
Not Provided

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00289653
205/2005
Not Provided
Not Provided
Centre for Addiction and Mental Health
Not Provided
Principal Investigator: Peter Selby, MD Centre for Addiction and Mental Health
Centre for Addiction and Mental Health
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP