1. Jean-François ETTER Evelyne LASZLO Jean-Pierre ZELLWEGER Charles PERROT Thomas PERNEGER University of Geneva, Switzerland Smoking reduction with NRT: a randomized trial

2. Support u This study was supported by - the Swiss National Science Foundation - the Swiss Federal Office of Public Health u Pharmacia provided nicotine and placebo products

3. Background  Only half of regular smokers are able to quit smoking during their lifetime  In Europe, 60-75% of smokers have NO intention to quit smoking in the next 6 months  These smokers will NOT participate in smoking cessation treatments  But many are interested in REDUCING their cigarette consumption

4. Objective  To assess whether NRT and placebo, administered in a REAL LIFE situation, REDUCED cigarette consumption in HEAVY smokers who did NOT want to quit smoking

5. Study design and participants u Design: Randomized trial with 3 arms: - nicotine, - placebo, - no treatment u Participants: 20+ cig./day, + no intention to quit smoking in next 6 months ("precontemplators"), + agreed to reduce cig./day by half

6. Sample and setting u Sample: - 923 at baseline, - 781 (85%) at 3 months, - 879 (95%) at 6 months u Setting: Population sample in Switzerland, 1999-2001 u Intention-to-treat analysis

7. Intervention u 6-month treatment of: – nicotine (n=265), combination of products, choice between : 15 mg patch, 4 mg gum, and / or 10 mg inhaler – matching placebo (n=269) – no intervention (n=389)

8. Intervention u Products were sent to participants by mail u Education was limited to a booklet u No in-person contacts, no telephone counseling

9. Results: cigarette consumption u Baseline = 30 cig. / day u Considering that participants lost to follow-up maintained their cigarette consumption, median reductions (cig. / day) were:

10. Results: mean daily cigarette consumption

11. Results: change in cig./day after 6 months CPD: 20 25 30 40 50

12. Results: smoking cessation after 6 months u Criterion: no puff of tobacco in past 4 weeks (FDA)

13. Results: 24-hour quit attempts

14. Results: motivation to quit smoking

15. Limitations of this study u No biochemical measure - real-life setting - which measure ? u Impact on exposure ? u Impact on health ? - long-term studies

16. Conclusions (1) u Both NRT and placebo helped smokers reduce their cigarette consumption and maintain this reduction over 6 months u The treatment was effective in the absence of medical guidance or supervision

17. Conclusions (2) u Large placebo effect, in particular in smokers of >30 cig./day (3rd control group) u The treatment had no deleterious impact on smoking cessation, quit attempts and motivation to quit smoking u Published in J Clin Psychopharmacol 2002;22:487-95.