Smoking While on Transdermal Nicotine Replacement Therapy: Effects on Craving and Cessation
1 other identifier
interventional
23
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 8, 2006
CompletedFirst Posted
Study publicly available on registry
February 10, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
October 5, 2018
CompletedOctober 5, 2018
December 1, 2017
1.2 years
February 8, 2006
July 10, 2017
December 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Carbon Monoxide Levels
Expired Co levels were measured to confirm smoking status
measured at week 10
Secondary Outcomes (1)
Smoking Cessation
Week 10
Study Arms (1)
single open-label treatment arm
EXPERIMENTALAdult 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Addiction and Mental Health
Toronto, Ontario, M5S 2S1, Canada
Related Publications (1)
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.
PMID: 23963055RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Peter Selby
- Organization
- Centre for Addiction and Mental Health
Study Officials
- PRINCIPAL INVESTIGATOR
Peter L. Selby, MBBS
Centre for Addiction and Mental Health
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. P. Selby
Study Record Dates
First Submitted
February 8, 2006
First Posted
February 10, 2006
Study Start
September 1, 2005
Primary Completion
December 1, 2006
Study Completion
July 1, 2009
Last Updated
October 5, 2018
Results First Posted
October 5, 2018
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share