Pre-treatment of nicotine for one month before quitting smoking: a randomised trial

ISRCTN	ISRCTN60585119
DOI	https://doi.org/10.1186/ISRCTN60585119
Protocol serial number	3200-067835
Sponsor	University of Geneva - Institute of Social and Preventive Medicine (Switzerland)
Funders	Swiss National Science Foundation (Switzerland) (ref: 3200-067835), Pfizer (Sweden) - provided nicotine gums at no charge (ref: NRA6430008)

Submission date: 10/06/2005
Registration date: 25/08/2005
Last edited: 28/07/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Jean-Francois Etter
Scientific

IMSP CMU
University of Geneva
1, rue Michel-Servet
Geneva 4
CH-1211
Switzerland

Phone	+41 (0)22 379 59 19
Email	jean-francois.etter@imsp.unige.ch

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Nicotine gum treatment before smoking cessation, a randomised trial
Study acronym	Etude nicotine
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Nircotine replacement therapy (NRT)
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)
Key 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
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	314
Key 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
Key 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
Date of first enrolment	01/09/2005
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Switzerland

Study participating centre

IMSP CMU

Geneva 4
CH-1211
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	08/06/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes