Tobacco Dependence Clinical Trial
Official title:
Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users. A Double Blind, Placebo Controlled Trial
Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop?
Secondary aim: To assess in details some side effects of varenicline i.e. nausea and
abnormal dreams.
100-200 long-term users of NRT will be enrolled in a placebo, controlled, randomized trial
with varenicline or placebo for 12 weeks to stop the use of NRT.
Assessments consist of carbon monoxide in expired air, p-cotinine, body-weight, questions
about craving, nausea and dreams. Primary result is percent not using NRT and not smoking at
12 weeks (point prevalence last 7 days) and secondary result is not smoking and not using
NRT at 12 months. Secondary aims, is a more detailed assessment of nausea and dreams;
well-known side effects of varenicline and secondary results are a qualitative description
of nausea and dreams.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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