Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users
- Conditions
- Tobacco Dependence
- Interventions
- Registration Number
- NCT00977249
- Lead Sponsor
- University Hospital, Gentofte, Copenhagen
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Long-term, daily NRT users (except nicotine patch) (>11 months) ex-smokers that are willing to try to stop the use of NRT and adhere to this protocol.
- More than 4 pieces of nicotine gum/ sublingual tablets/ lozenges/ per day, OR more than 3 inhaler cylinders per day, OR
- more than 10 puffs of nasal spray per day.
- Age < 18 years,
- CO Smokers,
- Pregnant and lactating women,
- Used varenicline before,
- Not able to cooperate,
- Other significant diseases that might influence the trial (such as moderate -severe cardiac disease, lung cancer,) in expired air > 7 ppm.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description varenicline support and visits Varenicline for 12 weeks. The treatment schedule for varenicline is: Varenicline tablets, 0.5 mg x 1 daily, day 1-3 Varenicline 0.5 mg x 2, day 4-6 Varenicline 1 mg x 2, day 7 up to 12 weeks placebo support and visits Placebo for 12 weeks placebo placebo Placebo for 12 weeks varenicline varenicline Varenicline for 12 weeks. The treatment schedule for varenicline is: Varenicline tablets, 0.5 mg x 1 daily, day 1-3 Varenicline 0.5 mg x 2, day 4-6 Varenicline 1 mg x 2, day 7 up to 12 weeks
- Primary Outcome Measures
Name Time Method Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml 12 weeks +/- 1 week
- Secondary Outcome Measures
Name Time Method is not smoking and not using NRT at 12 months (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml 12 months +/- 3 weeks
Trial Locations
- Locations (1)
Gentofte Hospital
🇩🇰Copenhagen, Hellerup, Denmark