Efficacy and Neural Correlates of Personalized Treatment With Transdermal Nicotine Replacement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tobacco Use Disorder Nicotine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Nicotine patch

Intervention Type DRUG

Positive Control Arm

Nicotine patch dose of 21mg coupled with nicotine mouthspray which is to be used as needed.

Group Type ACTIVE_COMPARATOR

Nicotine patch

Intervention Type DRUG

Nicotine mouthspray

Intervention Type DRUG

Interventions

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Nicotine patch

Intervention Type DRUG

Nicotine mouthspray

Intervention Type DRUG

Other Intervention Names

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Nicoderm Nicorette Quickmist

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No