Efficacy and Neural Correlates of Personalized Treatment With Transdermal Nicotine Replacement

NCT02439944 | Terminated Phase 2

• 1 other identifier: 095/2014
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cue induced brain activation

  up to 6 month follow-up

Study Arms (2)

Experimental Arm

EXPERIMENTAL

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

Positive Control Arm

ACTIVE COMPARATOR

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

Drug: Nicotine patch; Drug: Nicotine mouthspray

Interventions

Nicotine patch DRUG

Also known as: Nicoderm

Experimental Arm; Positive Control Arm

Nicotine mouthspray DRUG

Also known as: Nicorette Quickmist

Positive Control Arm

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health, Nicotine Dependence Clinic

Toronto, Ontario, M5T 1P7, Canada

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation

Interventions

Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Laurie Zawertailo, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

• Peter Selby, MBBS

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Scientist

Study Record Dates

• First Submitted: May 7, 2015
• First Posted: May 12, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 19, 2018

Record last verified: 2018-07

Locations

CA (1)