Smoking cessation or reduction with nicotine replacement therapy: a placebo-controlled double blind trial with nicotine gum and inhaler.
BACKGROUND
Even with effective smoking cessation medications, many smokers are unable to abruptly stop using tobacco. This finding has increased interest in smoking reduction as an interim step towards complete cessation.


METHODS
This multi-center, double-blind placebo-controlled study evaluated the efficacy and safety of nicotine 4 mg gum or nicotine 10 mg inhaler in helping smokers (N = 314) to reduce or quit smoking. It included smokers willing to control their smoking, and participants could set individual goals, to reduce or quit. The study was placebo-controlled, randomized in a ratio of 2:1 (Active:Placebo), and subjects could choose inhaler or gum after randomization. Outcome was short-term (from Week 6 to Month 4) and long-term (from Month 6 to Month 12) abstinence or reduction. Abstinence was defined as not a single cigarette smoked and expired CO readings of <10 ppm. Smoking reduction was defined as a reduction in number of cigarettes per day by 50% or more versus baseline, verified by a lower-than-baseline CO reading at each visit during the same periods.


RESULTS
Significantly more smokers managed to quit in the Active group than in the Placebo group. Sustained abstinence rates at 4 months were 42/209 (20.1%) subjects in the Active group and 9/105 (8.6%) subjects in the Placebo group (p = 0.009). Sustained abstinence rates at 12 months were 39/209 (18.7%) and 9/105 (8.6%), respectively (p = 0.019). Smoking reduction did not differ between the groups, either at short-term or long-term. Twelve-month reduction results were 17.2% vs. 18.1%, respectively. No serious adverse events were reported.


CONCLUSIONS
In conclusion, treatment with 10 mg nicotine inhaler or 4 mg nicotine chewing gum resulted in a significantly higher abstinence rate than placebo. In addition a large number of smokers managed to reduce their cigarette consumption by more than 50% compared to baseline.
Kralikova
Eva
E
Institute of Hygiene and Epidemiology, First Faculty of Medicine and the General University Hospital in Prague Tobacco Dependence Treatment Centre of the 3rd Medical Department - Department of Endocrinology and Metabolism, First Faculty of Medicine, Charles University in Prague and the General University Hospital, 128 00 Prague 2, Czech Republic. eva.kralikova@lf1.cuni.cz
Kozak
Jiri T
JT
Rasmussen
Thomas
T
Gustavsson
Gunnar
G
Le Houezec
Jacques
J
D000328:Adult; D000368:Aged; D001944:Breath Tests; D002248:Carbon Monoxide / Q000032:analysis; D002638:Chewing Gum; D003367:Cotinine / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D009538:Nicotine / Q000008:administration & dosage / Q000627:therapeutic use*; D016540:Smoking Cessation / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult
D002638:Chewing Gum; D009538:Nicotine; D002248:Carbon Monoxide; D003367:Cotinine