Efficacy and Neural Correlates of Personalized Treatment With Transdermal Nicotine Replacement

• Status: Terminated
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study involves the use of personalized nicotine patch dosing as a treatment strategy for smokers who cannot quit smoking after 2 weeks of using the standard nicotine patch dose. Functional Magnetic Resonance Imaging scans will also be obtained from all study participants before and after treatment. The first aim of the study is to determine if the treatment method under investigation is safe and more effective at increasing quit rates in smokers who do not respond to standard therapy.The second aim is to determine if there are any treatment- or cessation-related changes in brain function.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre for Addiction and Mental Health
• Treatments: Nicotine

Criteria

Inclusion Criteria:

• Daily tobacco smoker of

• Aged 19 to 65 years old

• Intending to quit smoking within the next 30 days

• Interested in using transdermal nicotine replacement therapy (nicotine patch)

Exclusion Criteria:

• At least weekly use of tobacco products other than cigarettes

• Breast feeding, pregnancy or not using a reliable form of birth control

• Any generalized skin disorders precluding the use of the patch

• Immediate post-myocardial infarction period or life-threatening arrhythmias, severe or worsening angina pectoris or recent cerebral vascular accident

• Any clinically significant electrocardiogram (ECG) abnormalities

• Currently using NRT or other smoking cessation pharmacotherapy

• Any known hypersensitivity or allergies to any of the components comprising the nicotine patch

• MRI contraindications (e.g., metal in body, claustrophobia) as per the CAMH RIC screening questionnaire

• Diagnosis of terminal illness.