A randomized clinical trial of nicotine lozenge for smokeless tobacco use.
BACKGROUND
Smokeless tobacco (ST) use is associated with adverse health consequences, and effective treatments are needed. Pilot data suggest that 4-mg nicotine lozenge decreases tobacco craving and nicotine withdrawal symptoms among ST users.


METHODS
We conducted a randomized, placebo-controlled multicenter clinical trial to evaluate the efficacy of 12 weeks of 4-mg nicotine lozenge for ST use.


RESULTS
We randomized 270 participants (136 active lozenge, 134 placebo). No significant differences were observed between the groups in biochemically confirmed all tobacco abstinence rates at Week 12 (36% lozenge vs. 27.6% placebo; odds ratio [OR] 1.5, 95% CI 0.7-2.1; p = .138). However, the 4-mg nicotine lozenge increased self-reported all tobacco abstinence (44.1% vs. 29.1%; OR 1.9, 95% CI 1.2-3.2; p = .011) and self-reported ST abstinence (50.7% vs. 34.3%; OR 2.0, 95% CI 1.2-3.2; p = .013) compared with placebo at the end of treatment (Week 12). Following target quit date (TQD), nicotine withdrawal symptoms decreased significantly with time (time effect = -.022 per day, SE = .003; p < .001) and was significantly lower for the active lozenge (treatment effect = -.213, SE = .071; p = .003). Tobacco craving also decreased significantly following TQD (time effect = -.071, SE = .006; p < .001) and was lower for the active nicotine lozenge (treatment effect = -.452, SE = .164; p = .006).


CONCLUSIONS
The 4-mg nicotine lozenge increased self-reported but not biochemically confirmed tobacco abstinence rates at 3 months. The use of the 4-mg nicotine lozenge is associated with decreased nicotine withdrawal symptoms and tobacco craving.
Ebbert
Jon O
JO
Mayo Clinic College of Medicine; Rochester, MN 55905, USA. ebbert.jon@mayo.edu
Severson
Herbert H
HH
Croghan
Ivana T
IT
Danaher
Brian G
BG
Schroeder
Darrell R
DR
D000284:Administration, Oral; D000328:Adult; D000339:Affect / Q000187:drug effects; D001288:Attention / Q000187:drug effects; D004304:Dosage Forms; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D018722:Nicotinic Agonists / Q000008:administration & dosage*; D011109:Polymethacrylic Acids / Q000008:administration & dosage*; D011145:Polyvinyls / Q000008:administration & dosage*; D016540:Smoking Cessation / Q000379:methods*; D013375:Substance Withdrawal Syndrome / Q000517:prevention & control; D061485:Tobacco Use Cessation Devices; D014029:Tobacco Use Disorder / Q000188:drug therapy*; D016896:Treatment Outcome
D004304:Dosage Forms; D018722:Nicotinic Agonists; D011109:Polymethacrylic Acids; D011145:Polyvinyls; D009538:Nicotine