Subjective effects of the nicotine lozenge: assessment of abuse liability.
BACKGROUND
A nicotine lozenge was developed as a novel smoking cessation aid. Abuse liability, which in this context refers to use by novices not addicted to tobacco, may be expected to be low for the lozenge due to the relatively slow route of nicotine absorption. However, its resemblance to commercially marketed lozenges and its palatability, intended to increase medication compliance, may increase its abuse liability, especially among younger individuals.


OBJECTIVE
The present study evaluated the abuse liability of the nicotine lozenge. Effects of the lozenge on cigarette craving were also measured.


METHODS
Subjective and physiological effects of the nicotine lozenge were tested in healthy adult smokers ( n=12, 22-55 years old); a group of younger subjects ( n=12, 18-21 years) was also included to allow for assessment of abuse liability of the lozenge in young adults specifically. Amphetamine and a confectionery lozenge were included in the study conditions as positive controls for abuse liability and palatability, respectively, and nicotine gum was included to allow for comparison with a marketed oral nicotine replacement product with low abuse liability.


RESULTS
The nicotine lozenge did not increase ratings of traditional abuse liability predictors (good effect, like effect, MBG scale of the ARCI), while amphetamine significantly increased ratings on these measures. The lozenge dose dependently decreased craving for cigarettes after 70 min of abstinence, but only in the older group. Palatability of the lozenge was rated lower than a confectionery lozenge, but not lower than nicotine mint gum.


CONCLUSIONS
Results suggest that the nicotine lozenge has low abuse liability, both in adults and young adults. The lozenge reduces craving to smoke, although craving reduction may not apply to young adults (18-21 years). Subjective effects of the lozenge are consistent with utility as a smoking cessation aid and are comparable to those of nicotine gum.
Houtsmuller
Elisabeth J
EJ
Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, Bayview Medical Center, 5510 Nathan Shock Drive, MD 21224-6823, Baltimore, USA. ehoutsm@jhmi.edu
Henningfield
Jack E
JE
Stitzer
Maxine L
ML
D000293:Adolescent; D000328:Adult; D016739:Behavior, Addictive / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage*; D016540:Smoking Cessation / Q000379:methods*; D013607:Tablets; D014029:Tobacco Use Disorder / Q000188:drug therapy* / Q000523:psychology
D013607:Tablets; D009538:Nicotine