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

Nicotine Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289653
• Other study ID #: 205/2005
• Status: Completed
• Phase: N/A
• Start date: September 2005
• Est. completion date: July 2009

Study information

• Verified date: December 2017
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 2009
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Drug:
• Nicoderm

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carbon Monoxide Levels	Expired Co levels were measured to confirm smoking status	measured at week 10
Secondary	Smoking Cessation	self reported # cigarettes per day	Week 10