Efficacy and Neural Correlates of Personalized Treatment With Transdermal Nicotine Replacement (iT-NRT)

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

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.

Study Overview

• Status: Terminated
• Conditions: Tobacco Use Disorder; Nicotine Dependence
• Intervention / Treatment: Drug: Nicotine patch; Drug: Nicotine mouthspray

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 1P7
      • Centre for Addiction and Mental Health, Nicotine Dependence Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm; Escalating nicotine patch dose to satiety over 6 weeks with dosage depending on the number of cigarettes smoked per day and the occurrence of adverse effects	Drug: Nicotine patch; Other Names: Nicoderm
Active Comparator: Positive Control Arm; Nicotine patch dose of 21mg coupled with nicotine mouthspray which is to be used as needed.	Drug: Nicotine patch; Other Names: Nicoderm; Drug: Nicotine mouthspray; Other Names: Nicorette Quickmist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cue induced brain activation	Brain activation in response to viewing emotional and smoking cues as measured by fMRI	up to 6 month follow-up

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health
• Investigators: Principal Investigator: Peter Selby, MBBS, Centre for Addiction and Mental Health

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: May 7, 2015
• First Submitted That Met QC Criteria: May 8, 2015
• First Posted (Estimate): May 12, 2015

Study Record Updates

• Last Update Posted (Actual): July 19, 2018
• Last Update Submitted That Met QC Criteria: July 16, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Functional Magnetic Resonance Imaging; Dependence; Tobacco; Smoking Cessation; Abstinence; Neuroimaging; Resting State; Nicotine; Cue Reactivity; Nicotine Patch; Quit Smoking; BOLD fMRI; Nicotine Mouth Spray; Transdermal Nicotine Replacement Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 095/2014