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

Completed

• Conditions: Cigarette smoking; Mental and Behavioural Disorders; Mental and behavioural disorders due to use of tobacco

• Registration Number: ISRCTN60585119
• Lead Sponsor: niversity of Geneva - Institute of Social and Preventive Medicine (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-25
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 314

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>2. Tobacco withdrawal symptoms at the target quit date and 2 months thereafter<br>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

Name	Time	Method
At 12 months, we will use as secondary outcome the recently recommended criterion of 6 months of continuous abstinence.<br>Other outcomes:<br>1. Quit attempts (number and duration)<br>2. Motivation to quit smoking<br>3. Confidence in ability to quit smoking, self-efficacy<br>4. Cigarette consumption<br>5. Level of dependence on cigarettes, assessed with the CDS-12 test<br>6. Side-effects of NRT<br>7. Attitudes towards NRT, in particular perception that NRT is dangerous