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

University Hospital, Gentofte, Copenhagen

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Tobacco Dependence

Treatments: Behavioral: support and visits; Drug: placebo; Drug: varenicline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00977249

EudraCTnumber 2008-006426-24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

varenicline

Active Comparator group

Description:

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

Treatment:

Drug: varenicline

Behavioral: support and visits

placebo

Placebo Comparator group

Description:

Placebo for 12 weeks

Treatment:

Drug: placebo

Behavioral: support and visits