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

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

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.

Study Overview

• Status: Unknown
• Conditions: Tobacco Dependence
• Intervention / Treatment: Drug: placebo; Behavioral: support and visits; Drug: varenicline

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Hellerup
    • Copenhagen, Hellerup, Denmark, 2900
      • Recruiting
      • Gentofte Hospital
      • Contact: Helle Johnson, reg Nures; Phone Number: +4539773512
      • Contact: Helle Johnson, reg.nures
      • Principal Investigator: Philip Tønnesen, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: varenicline; 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	Behavioral: support and visits; visits at weeks 0,2,4,6,9 and 12 and 12 months; Drug: varenicline
Placebo Comparator: placebo; Placebo for 12 weeks	Drug: placebo; Behavioral: support and visits; visits at weeks 0,2,4,6,9 and 12 and 12 months

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University Hospital, Gentofte, Copenhagen
• Collaborators: Pfizer
• Investigators: Principal Investigator: Philip Tønnesen, M.D., Gentofte Hospital

Publications and helpful links

General Publications

• Tonnesen P, Mikkelsen K. Varenicline to stop long-term nicotine replacement use: a double-blind, randomized, placebo-controlled trial. Nicotine Tob Res. 2013 Feb;15(2):419-27. doi: 10.1093/ntr/nts146. Epub 2012 Sep 27.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: September 14, 2009
• First Submitted That Met QC Criteria: September 14, 2009
• First Posted (Estimate): September 15, 2009

Study Record Updates

• Last Update Posted (Estimate): September 15, 2009
• Last Update Submitted That Met QC Criteria: September 14, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: varenicline; adverse effects; long term nicotine gum use
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: EudraCTnumber 2008-006426-24