Condition category
Mental and Behavioural Disorders
Date applied
10/06/2005
Date assigned
25/08/2005
Last edited
28/07/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Jean-Francois Etter

ORCID ID

Contact details

IMSP CMU
University of Geneva
1
rue Michel-Servet
Geneva 4
CH-1211
Switzerland
+41 (0)22 379 59 19
jean-francois.etter@imsp.unige.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3200-067835

Study information

Scientific title

Nicotine gum treatment before smoking cessation, a randomised trial

Acronym

Etude nicotine

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Informed consent document can be found at http://www.stop-tabac.ch/fr_hon/Informed_consent_pre-cessationNRT.pdf

Condition

Cigarette smoking

Intervention

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.

Intervention type

Drug

Phase

Not Specified

Drug names

Nircotine replacement therapy (NRT)

Primary outcome measures

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 measures

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

Overall trial start date

01/09/2005

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

860 (amended as of 09/02/2009 = 314 participants)

Participant 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

Recruitment start date

01/09/2005

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Switzerland

Trial participating centre

IMSP CMU
Geneva 4
CH-1211
Switzerland

Sponsor information

Organisation

University of Geneva - Institute of Social and Preventive Medicine (Switzerland)

Sponsor details

IMSP CMU
University of Geneva
1
rue Michel Servet
Geneva 4
CH-1211
Switzerland
+41 (0)22 379 59 19
jean-francois.etter@imsp.unige.ch

Sponsor type

University/education

Website

http://www.unige.ch

Funders

Funder type

Industry

Funder name

Swiss National Science Foundation (Switzerland) (ref: 3200-067835)

Alternative name(s)

Schweizerische Nationalfonds, SNSF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Switzerland

Funder name

Pfizer (Sweden) - provided nicotine gums at no charge (ref: NRA6430008)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results on http://www.ncbi.nlm.nih.gov/pubmed/19506172

Publication citations

  1. Results

    Etter JF, Huguelet P, Perneger TV, Cornuz J, Nicotine gum treatment before smoking cessation: a randomized trial., Arch. Intern. Med., 2009, 169, 11, 1028-1034, doi: 10.1001/archinternmed.2009.12.

Additional files

Editorial Notes