Pilot study of a new nicotine replacement therapy for smoking cessation.
This will be a pilot study of a new nicotine replacement therapy with two different directions for use in smoking cessation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
258
Nicotine replacement therapy with Standard NRT user direction
Nicotine replacement therapy with a Novel NRT user direction
Department of Primary Care and General Practice, University of Birmingham
Birmingham, United Kingdom
Tobacco Dependence Research Centre at Barts and The London Queen Mary's School of Medicine and Dentistry
London, United Kingdom
Mean hourly and daily number of doses used
Time frame: throughout study
Mean number of NRT use occasions per day
Time frame: Week 1, 2, and 3
Ratings of craving/urge to smoke and withdrawal symptoms
Time frame: Day 1-14, and Day 20
Self-reported continuous abstinence from smoking, verified by an exhaled CO level of less than 10 ppm
Time frame: Day 1-21
Cotinine levels
Time frame: At baseline and week 3
Product acceptability
Time frame: At week 3 visit
Safety Assessments will consist of monitoring and recording all non-serious Adverse Events and Serious Adverse Events , their frequency, severity, seriousness, and relationship to the investigational product.
Time frame: throughout duration of the study (+ 30 days for spontaneous SAEs)
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