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04 February 2012
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| [ Print-friendly version ] |
| Pre-treatment of nicotine for one month before quitting smoking: a randomised trial |
| ISRCTN | ISRCTN60585119 |
| ClinicalTrials.gov identifier | |
| 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
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| 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 |
| 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 |
| 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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