Efficacy and Neural Correlates of Personalized Treatment With Transdermal Nicotine Replacement

Nicotine Dependence Clinical Trial

— iT-NRT  

Official title:

Efficacy and Neural Correlates of Personalized Treatment With Transdermal Nicotine Replacement: A Randomized, Controlled Pilot Study in Motivated Smokers Unable to Quit With Standard Dosing

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02439944
• Other study ID #: 095/2014
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: July 2015
• Est. completion date: December 2017

Study information

• Verified date: July 2018
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Nicotine Replacement Therapy (NRT) is limited in efficacy. One possible explanation for this limited efficacy is that the nicotine dose received in standard therapy is not enough to replace the amount of nicotine that smokers typically receive from their cigarettes. In an effort to counteract this problem, this study will increase the nicotine patch dose of smokers until they no longer feel the need to keep smoking or they cannot tolerate a higher nicotine dose. Smokers who cannot quit using 21 mg nicotine patch for 2 weeks will be randomized to either the experimental arm of the study where nicotine patch doses will be adjusted according to individual need or the positive control arm where standard NRT smoking cessation therapy will be employed. The primary outcome measure will be continuous abstinence during the last 4 weeks of treatment. In addition, participants will be assessed to see how treatment has impacted their resting state neural activity as well as their responsiveness to smoking and emotional cues. Follow up sessions will be used to assess long term abstinence as well as long term change in neural activation.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Drug:
• Nicotine patch

• Nicotine mouthspray

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health, Nicotine Dependence Clinic	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	4 weeks continuous smoking abstinence	4 weeks of abstinence without a single puff of a cigarette confirmed by self-report and exhaled carbon monoxide (CO less than or equal to 4ppm)	Treatment weeks 9-12 inclusive
Secondary	Cue induced brain activation	Brain activation in response to viewing emotional and smoking cues as measured by fMRI	up to 6 month follow-up