Pre-treatment of nicotine for one month before quitting smoking: a randomised trial
| ISRCTN | ISRCTN60585119 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60585119 |
| Secondary identifying numbers | 3200-067835 |
- 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
Scientific
IMSP CMU
University of Geneva
1, rue Michel-Servet
Geneva 4
CH-1211
Switzerland
| Phone | +41 (0)22 379 59 19 |
|---|---|
| jean-francois.etter@imsp.unige.ch |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Informed consent document can be found at http://www.stop-tabac.ch/fr_hon/Informed_consent_pre-cessationNRT.pdf |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Nircotine replacement therapy (NRT) |
| Primary outcome measure | 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 study start date | 01/09/2005 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 860 (amended as of 09/02/2009 = 314 participants) |
| 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
CH-1211
Switzerland
Sponsor information
University of Geneva - Institute of Social and Preventive Medicine (Switzerland)
University/education
University/education
IMSP CMU
University of Geneva
1, rue Michel Servet
Geneva 4
CH-1211
Switzerland
| Phone | +41 (0)22 379 59 19 |
|---|---|
| jean-francois.etter@imsp.unige.ch | |
| Website | http://www.unige.ch |
"ROR" |
https://ror.org/01swzsf04 |
Funders
Funder type
Industry
Swiss National Science Foundation (Switzerland) (ref: 3200-067835)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Schweizerischer Nationalfonds, Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerische Nationalfonds, SNF, SNSF, FNS
- Location
- Switzerland
Pfizer (Sweden) - provided nicotine gums at no charge (ref: NRA6430008)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 08/06/2009 | Yes | No |
