Short communicationAbility of a new oral nicotine substitute to reduce smoking urge in moderate smokers
Introduction
Nicotine replacement therapies (NRT) are widely approved as a pharmacological help for smoking cessation (Fiore et al., 1994, Henningfield, 1995, Li Wan Po, 1993, Silagy et al., 1998, Tang et al., 1994). In 1984, nicotine gum was the first NRT to be approved by the FDA. However, nicotine gum is rejected by many smokers due to fillings, dyspepsia, bridgework, unpleasant taste or for esthetic reasons. To avoid these drawbacks, new convenient oral nicotine formulations were developed, including sublingual tablets and lozenges. Institut de Recherche Pierre Fabre has developed a lozenge to be sucked, containing 1.5mg of nicotine and presenting with pharmacokinetic profile similar to 2-mg nicotine gums, which should offer an alternative to other NRT in low to moderate smokers. The present study was designed to determine whether this 1.5-mg nicotine lozenge is effective to reduce smoking urge and other withdrawal symptoms that are frequently observed during smoking abstinence.
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Materials and methods
This randomized, double-blind, placebo-controlled, crossover study carried out at FORENAP Pharma facilities (France) was approved by an independent ethics committee.
Results
Results are expressed by their mean +/− standard error. A sequence effect (order of administration) was never observed, that validates the comparison of treatments according to the crossover design.
One subject was excluded from the analyses because of Holter ECG device failure during the first study period, which precluded Holter ECG data analyses. No other protocol deviations were observed. Consequently, 23 subjects were included in the pharmacodynamic analyses.
Discussion
The present findings show that Nicopass®, a nicotine lozenge dosed at 1.5 mg of nicotine, rapidly alleviates smoking urge after only one intake in moderate smokers. Indeed, while both nicotine lozenge and placebo significantly reduced smoking urge, this effect was significantly more important with nicotine lozenge than with placebo. The superiority of nicotine lozenge over placebo to relief from smoking urge was obtained using the 1-item VAS and the multi-item questionnaire QSU, with a similar
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