NICOTINE POLACRILEX DOSE EFFECTS - SERUM NICOTINE LEVELS AND SENSORY CHARACTERISTICS

This study evaluated serum nicotine and sensory differences of five di fferent doses of nicotine polacrilex (0.0, 0.5, 1.0, 2.0 and 4.0 mg ni cotine), three of which have been used as placebo doses in clinical tr ials (0.0, 0.5, and 1.0 mg) and two of which are currently available a s pharmacologic treatments for smoking cessation (2.0 or 4.0 mg nicoti ne). Twenty-one smokers received, on different days and in random orde r, five pieces of each of the five doses of polacrilex. The objective of the study was to evaluate whether consistent serum nicotine and sen sory differences would be observed between the doses. After 5 h use, t he 0.0, 0.5, 1.0, 2.0, and 4.0 mg doses produced the following results : (1) there was a linear trend across the placebo doses of nicotine po lacrilex in serum nicotine and nicotine flavor, although pairwise dose comparisons were not significant, (2) the 0.0 and 0.5 mg placebo dose s resulted in serum nicotine and sensory ratings that were significant ly different from the 2.0 mg dose, and even more so from the 4.0 mg do se, (3) the 1.0 mg dose was not different from the 2.0 mg dose on seru m nicotine level and several sensory characteristics, though it was di fferent from the 4.0 mg dose on both, and (4) the 4.0 mg dose resulted in significantly higher serum nicotine and usually higher sensory rat ings than the 2.0 mg dose. Since the 0.0 mg placebo achieves sensory e ffects that are comparable to the nicotine-containing placebo doses, i t is recommended over the 0.5 and 1.0 mg doses as the nicotine polacri lex placebo of choice in most clinical trials.