Smoking reduction treatment with 4-mg nicotine gum: a double-blind, randomized, placebo-controlled study.
BACKGROUND
Smoking reduction may provide a harm-reduction alternative treatment for smokers who are not ready to quit smoking. This study evaluated the efficacy of nicotine gum in helping smokers reduce or quit smoking.


METHODS
This randomized, double-blind, placebo-controlled trial involved 364 smokers who were not ready to quit but were willing to reduce their smoking intensity. Participants received either 4-mg nicotine gum (n = 184) or placebo gum (n = 180) as desired for up to 12 months. The primary outcome was sustained smoking reduction, which was defined as a decrease in daily cigarette consumption of at least 50% compared with baseline. Secondary measures included point-prevalence abstinence, intention to quit, and cardiovascular risk markers.


RESULTS
At 4 months, the sustained smoking reduction rate in the nicotine gum group was twice that of the placebo group (15.8% versus 6.7%, P = .008). Point-prevalence abstinence was 6.6% for the nicotine gum group and 2.2% for the placebo group (P = .07). At 13 months, there was a significant difference in the smoking reduction rate for the nicotine (8.2%) and placebo (2.8%) groups (P = .036). At month 13, the abstinence rates were 12% and 4.5% for the nicotine and placebo groups, respectively (P = .012). Concomitant use of nicotine gum and cigarette smoking was well tolerated. Carbon monoxide levels decreased significantly (P = .01).


CONCLUSIONS
Nicotine gum may be an efficacious harm-reduction alternative for smokers who are not ready to quit and may promote smoking cessation, the ultimate goal in the treatment of tobacco dependence.
Batra
Anil
A
Department of Psychiatry and Psychotherapy, University Hospital of Tübingen, Osianderstrasse 24, D-72076 Tübingen, Germany. anil.batra@med.uni-tuebingen.de
Klingler
Karl
K
Landfeldt
Björn
B
Friederich
Hubertus M
HM
Westin
Ake
A
Danielsson
Tobias
T
D000284:Administration, Oral; D000328:Adult; D001944:Breath Tests / Q000379:methods; D002245:Carbon Dioxide / Q000032:analysis; D002248:Carbon Monoxide / Q000032:analysis; D002638:Chewing Gum; D003367:Cotinine / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage / Q000627:therapeutic use*; D018722:Nicotinic Agonists / Q000008:administration & dosage / Q000627:therapeutic use; D010349:Patient Compliance / Q000523:psychology / Q000706:statistics & numerical data; D016540:Smoking Cessation / Q000379:methods* / Q000523:psychology / Q000706:statistics & numerical data; D000074606:Smoking Prevention; D013861:Thiocyanates / Q000097:blood; D013997:Time Factors; D016896:Treatment Outcome
D002638:Chewing Gum; D018722:Nicotinic Agonists; D013861:Thiocyanates; D002245:Carbon Dioxide; D009538:Nicotine; D002248:Carbon Monoxide; D003367:Cotinine; C031760:thiocyanate