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

Center for Addiction and Mental Health (CAMH)

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Nicotine Dependence; Tobacco Use Disorder

Treatments: Drug: Nicotine patch; Drug: Nicotine mouthspray

Study type: Interventional

Funder types: Other

Identifiers

NCT02439944

095/2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Experimental Arm

Experimental group

Description:

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

Treatment:

Drug: Nicotine patch

Positive Control Arm

Active Comparator group

Description:

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

Treatment:

Drug: Nicotine mouthspray

Drug: Nicotine patch