Clinical trial NCT02439944: Efficacy and Neural Correlates of Personalized Treatment With Transdermal Nicotine Replacement
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Tobacco Use Disorder
Nicotine Dependence
Keywords: Nicotine Patch
Nicotine Mouth Spray
Smoking Cessation
Quit Smoking
Abstinence
Dependence
Nicotine
Tobacco
Transdermal Nicotine Replacement Therapy
Functional Magnetic Resonance Imaging
Neuroimaging
Cue Reactivity
Resting State
BOLD fMRI
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: 4 weeks continuous smoking abstinence
timeFrame: Treatment weeks 9-12 inclusive
Secondary outcomes:
measure: Cue induced brain activation
timeFrame: up to 6 month follow-up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health, Nicotine Dependence Clinic
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Laurie Zawertailo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Addiction and Mental Health
name: Peter Selby, MBBS
role: PRINCIPAL_INVESTIGATOR
References: