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

Tobacco Dependence Clinical Trial

Official title:

Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users. A Double Blind, Placebo Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00977249
• Other study ID #: EudraCTnumber 2008-006426-24
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: September 14, 2009
• Last updated: September 14, 2009
• Start date: September 2009
• Est. completion date: December 2011

Study information

• Verified date: September 2009
• Source: University Hospital, Gentofte, Copenhagen
• Contact: Philip Tønnesen, M.D:
• Phone: +4539773508
• Email: philipt[@]dadlnet.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Dependence

Intervention

Behavioral:
• support and visits
visits at weeks 0,2,4,6,9 and 12 and 12 months

Drug:
• varenicline

• placebo

Locations

Country	Name	City	State
Denmark	Gentofte Hospital	Copenhagen	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen	Pfizer

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No