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Pre-treatment of nicotine for one month before quitting smoking: a randomised trial
ISRCTN ISRCTN60585119
DOI 10.1186/ISRCTN60585119
ClinicalTrials.gov identifier
EudraCT number
Public title Pre-treatment of nicotine for one month before quitting smoking: a randomised trial
Scientific title Nicotine gum treatment before smoking cessation, a randomised trial
Acronym Etude nicotine
Serial number at source 3200-067835
Study hypothesis Nicotine replacement therapy (NRT) taken for one month before and two months after smoking cessation will be more effective than usual care i.e. NRT for two months after the quit date.

Please note that as of 09/02/09 this record was updated to include an amended anticipated end date. The initial anticipated end date was 30/06/2011.
Lay summary
Ethics approval Added 09/02/2009:
1. The Ethics Board of the Association des médecins du canton de Genève (AMG) gave approval on the 15th January 2004
2. The Ethics Board of the Faculty of Biology and Medicine, University of Lausanne gave approval on the 20th April 2006
Study design Randomised controlled trial
Countries of recruitment Switzerland
Disease/condition/study domain Cigarette smoking
Participants - inclusion criteria 1. Smokes 15+ cigarettes per day
2. Lives in the Swiss cantons of Geneva or Vaud
3. Daily smoker for at least 3 years
4. Aged 18 years or more, either sex
5. Seriously intends to quit smoking in the next two months
6. Willing to use 4 mg nicotine gums for one month before and two months after smoking cessation
7. Willing to postpone smoking cessation until one month after enrolment in the study
8. Commits to take part in all follow-up procedures, including if he/she is attributed to the control group
9. Declares to understand and accept the control-group procedure
10. Signs the informed consent form
11. Has access to internet at home or at work and provides a valid e-mail address
12. Provides a telephone number
13. Provides a health status questionnaire signed by a physician and by the participant
Participants - exclusion criteria 1. Current use of NRT or bupropion
2. Pregnancy, lactation or planned pregnancy
3. Unstable angina pectoris
4. Myocardial infarction or cerebral vascular accident within the last 3 months
5. Under psychiatric care or medication that might interfere with the trial
6. Alcohol or other drug problem that might interfere with the trial
7. Having a mouth pathology, and/or dental problem that might interfere with gum use
Anticipated start date 01/09/2005
Anticipated end date 31/12/2009
Status of trial Completed
Patient information material Informed consent document can be found at http://www.stop-tabac.ch/fr_hon/Informed_consent_pre-cessationNRT.pdf
Target number of participants 860 (amended as of 09/02/2009 = 314 participants)
Interventions Nicotine gum (4 mg) for one month before and two months after quitting smoking. The control group will receive similar gums, but only after they quit smoking, for 2 months. No placebos will be used.
Primary outcome measure(s) 1. Smoking status at the target quit date, and 2, 12 and 60 months thereafter. We will use the criterion recommended by the U.S. Food and Drugs Administration (FDA) to assess outcome in smoking cessation studies: not having smoked even one puff of tobacco during the previous 4 weeks, and the criterion recommended in a recent guideline: not having smoked even one puff of tobacco in the previous 7 days. At 12 months only, smoking abstinence will be verified by saliva cotinine and, if positive, by expired carbon monoxide.
2. Tobacco withdrawal symptoms at the target quit date and 2 months thereafter
3. Utilisation of nicotine gums at the target quit date and 2 months thereafter (number of gums per day and duration of use)
Secondary outcome measure(s) At 12 months, we will use as secondary outcome the recently recommended criterion of 6 months of continuous abstinence.
Other outcomes:
1. Quit attempts (number and duration)
2. Motivation to quit smoking
3. Confidence in ability to quit smoking, self-efficacy
4. Cigarette consumption
5. Level of dependence on cigarettes, assessed with the CDS-12 test
6. Side-effects of NRT
7. Attitudes towards NRT, in particular perception that NRT is dangerous
Sources of funding 1. Swiss National Science Foundation (Switzerland) (ref: 3200-067835)
2. Pfizer (Sweden) - provided nicotine gums at no charge (ref: NRA6430008)
Trial website
Publications 2009 results on http://www.ncbi.nlm.nih.gov/pubmed/19506172
Contact name Mr  Jean-Francois  Etter
  Address IMSP CMU
University of Geneva
1, rue Michel-Servet
  City/town Geneva 4
  Zip/Postcode CH-1211
  Country Switzerland
  Tel +41 (0)22 379 59 19
  Fax +41 (0)22 379 59 12
  Email jean-francois.etter@imsp.unige.ch
Sponsor University of Geneva - Institute of Social and Preventive Medicine (Switzerland)
  Address IMSP CMU
University of Geneva
1, rue Michel Servet
  City/town Geneva 4
  Zip/Postcode CH-1211
  Country Switzerland
  Tel +41 (0)22 379 59 19
  Fax +41 (0)22 379 59 12
  Email jean-francois.etter@imsp.unige.ch
  Sponsor website: http://www.unige.ch
Date applied 10/06/2005
Last edited 28/07/2009
Date ISRCTN assigned 25/08/2005
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