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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02439944
Recruitment Status : Terminated (full RCT funded. no need to continue pilot data collection.)
First Posted : May 12, 2015
Last Update Posted : July 19, 2018
Information provided by (Responsible Party):
Laurie Zawertailo, Centre for Addiction and Mental Health

Brief 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.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Nicotine Dependence Drug: Nicotine patch Drug: Nicotine mouthspray Phase 2 Phase 3

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  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

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 Name: 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 Name: Nicoderm

Drug: Nicotine mouthspray
Other Name: Nicorette Quickmist

Primary Outcome Measures :
  1. 4 weeks continuous smoking abstinence [ Time Frame: Treatment weeks 9-12 inclusive ]
    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)

Secondary Outcome Measures :
  1. Cue induced brain activation [ Time Frame: up to 6 month follow-up ]
    Brain activation in response to viewing emotional and smoking cues as measured by fMRI

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02439944

Canada, Ontario
Centre for Addiction and Mental Health, Nicotine Dependence Clinic
Toronto, Ontario, Canada, M5T 1P7
Sponsors and Collaborators
Centre for Addiction and Mental Health
Principal Investigator: Laurie Zawertailo, PhD Centre for Addiction and Mental Health
Principal Investigator: Peter Selby, MBBS Centre for Addiction and Mental Health

Responsible Party: Laurie Zawertailo, Clinical Scientist, Centre for Addiction and Mental Health Identifier: NCT02439944     History of Changes
Other Study ID Numbers: 095/2014
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

Keywords provided by Laurie Zawertailo, Centre for Addiction and Mental Health:
Nicotine Patch
Nicotine Mouth Spray
Smoking Cessation
Quit Smoking
Transdermal Nicotine Replacement Therapy
Functional Magnetic Resonance Imaging
Cue Reactivity
Resting State

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action