NCT00977249

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

Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users. A Double Blind, Placebo Controlled Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University Hospital, Gentofte, Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Tobacco Dependence

Interventions

Type	Name	Description
BEHAVIORAL	support and visits	visits at weeks 0,2,4,6,9 and 12 and 12 months
DRUG	varenicline
DRUG	placebo

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2009-09-15
• Last updated: 2009-09-15

Locations

1 site across 1 country: Denmark