Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Tobacco Dependence

Clinical Trial Details

NCT number	NCT00977249
Study type	Interventional
Source	University Hospital, Gentofte, Copenhagen
Contact	Philip Tønnesen, M.D:
Phone	+4539773508
Email	philipt@dadlnet.dk
Status	Recruiting
Phase	Phase 2/Phase 3
Start date	September 2009
Completion date	December 2011

View Details

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