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

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Gentofte, Copenhagen
• Collaborator: Pfizer
• Treatments: Nicotine; Varenicline

Criteria

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.