Varenicline for long-term nicotine replacement therapy (NRT) users A double blind, placebo controlled trial - Long-term NRT:varenicline

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-006426-34-DK

Enrollment

200

Registered

2008-11-27

Start date

2009-03-06

Completion date

Unknown

Last updated

2021-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long-term dependence of nicotine substitution products (gum, inhaler, sublingual, spay)

Interventions

Trade Name: Champix (varenicline) Product Name: Campix Product Code: NA Pharmaceutical Form: Tablet INN or Proposed INN: varenicline Tartrate CAS Number: 375815-87-5 Current Sponsor code: CP-526,555 O

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Long-term, daily NRT users (except nicotine patch) (>11 months) ex-smokers that is 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria 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,) Age 7 ppm

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop? ;Secondary Objective: Secondary aim: To assess in details some side effects of varenicline i.e. nausea and abnormal dreams. ;Primary end point(s): 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-continine < 15 ng/ml. and secondary result 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-continine < 15 ng/ml. 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.	—

Measure

Time frame

Main Objective: Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop? ;Secondary Objective: Secondary aim: To assess in details some side effects of varenicline i.e. nausea and abnormal dreams. ;Primary end point(s): 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-continine < 15 ng/ml. and secondary result 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-continine < 15 ng/ml. 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.

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026