A multicenter phase 3 trial of lobeline sulfate for smoking cessation.
OBJECTIVE
To evaluate the safety and efficacy of sublingual lobeline sulfate for smoking cessation.


METHODS
A multicenter (3 sites), double-blind, parallel, placebo-controlled, phase 3 smoking cessation trial of sublingual formulation of lobeline sulfate. A total of 750 smokers (250 per site) were randomized to either treatment (lobeline sulfate) or placebo with individual smoking cessation counseling lasting up to approximately 10 minutes.


RESULTS
Efficacy revealed no statistical significance (P = 0.62) for lobeline sulfate as a smoking cessation aid.


CONCLUSIONS
Sublingual formulation of lobeline sulfate does not appear to be an effective smoking cessation aid.
Glover
Elbert D
ED
Department of Public and Community Health, Center for Health Behavior Research, University of Maryland, College Park School of Public Health, College Park, MD eglover1@umd.edu, USA.
Rath
Jessica M
JM
Sharma
Eva
E
Glover
Penny N
PN
Laflin
Molly
M
Tonnesen
Philip
P
Repsher
Lawrence
L
Quiring
John
J
D000286:Administration, Sublingual; D000293:Adolescent; D000328:Adult; D000368:Aged; D003376:Counseling; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008120:Lobeline / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D018722:Nicotinic Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D012907:Smoking / Q000188:drug therapy*; D016540:Smoking Cessation / Q000379:methods* / Q000523:psychology; D016896:Treatment Outcome; D055815:Young Adult
D018722:Nicotinic Agonists; D008120:Lobeline