Tobacco Dependence
Conditions
Keywords
long term nicotine gum use, varenicline, adverse effects
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.
Interventions
BEHAVIORALsupport and visits
visits at weeks 0,2,4,6,9 and 12 and 12 months
DRUGvarenicline
DRUGplacebo
Sponsors
Pfizer
University Hospital, Gentofte, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Denmark
Contacts
Primary ContactPhilip Tønnesen, M.D:
Backup ContactHelle Johnson, reg. nurse
Outcome results
None listed