A comparison of a novel nicotine replacement therapy and placebo treatment in smokers motivated to quit smoking.
Efficacy and safety study following use of a novel nicotine replacement therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
479
Gentofte University Hospital
Hellerup, Denmark
University of Heidelberg
Mannheim, Germany
University Hospital of Tuebingen
Tübingen, Germany
Self-reported continuous abstinence from smoking verified by exhaled CO levels of less than 10 ppm.
Time frame: at weeks 2, 6, 24 and 52
Self-reported continuous abstinence from smoking, verified by exhaled CO levels of less than 10 ppm.
Time frame: weeks 2, 4, 8, 12, 16, and 20
Self-reported 7-day point prevalence abstinence from smoking verified by exhaled CO levels of less than 10 ppm.
Time frame: weeks 4, 6, 8, 12, 16, 20, 24, and 52
Ratings of craving/urge to smoke and withdrawal symptoms.
Time frame: baseline to 24 weeks
Cotinine levels in saliva.
Time frame: baseline, and weeks 2, 6, 12 and 24
Product acceptability
Time frame: weeks 1, 6 and 12
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