170 likes | 298 Vues
Smoking reduction with NRT: a randomized trial. Jean-François ETTER Evelyne LASZLO Jean-Pierre ZELLWEGER Charles PERROT Thomas PERNEGER University of Geneva, Switzerland. Support.
E N D
Smoking reduction with NRT: a randomized trial Jean-François ETTER Evelyne LASZLO Jean-Pierre ZELLWEGER Charles PERROT Thomas PERNEGER University of Geneva, Switzerland
Support • This study was supported by - the Swiss National Science Foundation - the Swiss Federal Office of Public Health • Pharmacia provided nicotine and placebo products
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
Objective • To assess whether NRT and placebo,administered in a REAL LIFE situation,REDUCED cigarette consumptionin HEAVY smokerswho did NOT want to quit smoking
Study design and participants • Design: Randomized trial with 3 arms: - nicotine, - placebo, - no treatment • Participants: 20+ cig./day, + no intention to quit smoking in next 6 months ("precontemplators"), + agreed to reduce cig./day by half
Sample and setting • Sample:- 923 at baseline, - 781 (85%) at 3 months,- 879 (95%) at 6 months • Setting: Population sample in Switzerland, 1999-2001 • Intention-to-treat analysis
Intervention • 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)
Intervention • Products were sent to participants by mail • Education was limited to a booklet • No in-person contacts, no telephone counseling
Results: cigarette consumption • Baseline = 30 cig. / day • Considering that participants lost to follow-up maintained their cigarette consumption, median reductions (cig. / day) were:
Results: change in cig./day after 6 months CPD: 20 25 30 40 50
Results: smoking cessation after 6 months • Criterion: no puff of tobacco in past 4 weeks (FDA)
Limitations of this study • No biochemical measure - real-life setting - which measure ? • Impact on exposure ? • Impact on health ? - long-term studies
Conclusions (1) • Both NRT and placebo helped smokers reduce their cigarette consumption and maintain this reduction over 6 months • The treatment was effective in the absenceof medical guidance or supervision
Conclusions (2) • Large placebo effect, in particular in smokers of >30 cig./day (3rd control group) • The treatment had no deleterious impact on smoking cessation, quit attempts and motivation to quit smoking • Published in J Clin Psychopharmacol 2002;22:487-95.