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Trial record 1 of 1 for:    NCT00977249
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Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users

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ClinicalTrials.gov Identifier: NCT00977249
Recruitment Status : Unknown
Verified September 2009 by University Hospital, Gentofte, Copenhagen.
Recruitment status was:  Recruiting
First Posted : September 15, 2009
Last Update Posted : September 15, 2009
Sponsor:
Collaborator:
Pfizer
Information provided by:
University Hospital, Gentofte, Copenhagen

Tracking Information
First Submitted Date  ICMJE September 14, 2009
First Posted Date  ICMJE September 15, 2009
Last Update Posted Date September 15, 2009
Study Start Date  ICMJE September 2009
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2009)
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 [ Time Frame: 12 weeks +/- 1 week ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2009)
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 [ Time Frame: 12 months +/- 3 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users
Official Title  ICMJE Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users. A Double Blind, Placebo Controlled Trial
Brief 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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tobacco Dependence
Intervention  ICMJE
  • Behavioral: support and visits
    visits at weeks 0,2,4,6,9 and 12 and 12 months
  • Drug: varenicline
  • Drug: placebo
Study Arms  ICMJE
  • 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

    Interventions:
    • Behavioral: support and visits
    • Drug: varenicline
  • Placebo Comparator: placebo
    Placebo for 12 weeks
    Interventions:
    • Behavioral: support and visits
    • Drug: placebo
Publications * Tønnesen 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 14, 2009)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2011
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00977249
Other Study ID Numbers  ICMJE EudraCTnumber 2008-006426-24
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chief Physician Philip Tønnesen, M.D., Gentofte University Hospital
Study Sponsor  ICMJE University Hospital, Gentofte, Copenhagen
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Philip Tønnesen, M.D. Gentofte Hospital
PRS Account University Hospital, Gentofte, Copenhagen
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP