Of 60 individuals screened, 60 subjects were eligible and randomized to receive treatment (30 lozenge, 30 placebo) and included in the final analysis. Subjects were similar at baseline (). The overall study drop-out rate was 22% at 6 months.
Baseline Demographics of Smokeless Tobacco Users in a Pilot Study of Mailed Nicotine Lozenge and Assisted Self-Help (N= 60)*
3.2. Lozenge Use
During the first week there were 2 subjects (1 in each treatment group) who reported using more than 16 lozenges per day. No subjects reported using more than 16 lozenges per day after the first week. For both groups, median lozenge use for the first week was 8 lozenges per day [interquartile range (IQR): 4 to 9 for nicotine lozenge vs. IQR: 4 to 12 for placebo] and 5 lozenges per day (IQR: 3 to 9 vs. IQR: 2 to 8, respectively) for weeks 2 to 3. For weeks 4 to 7, lozenge use was higher in the nicotine lozenge groups (median 4; IQR: 2 to 6) compared to placebo (median 1; IQR: 0 to 3; p < 0.001). For weeks 8 to 12, median lozenge use was higher in the nicotine lozenge group (median 3; IQR: 0 to 5) compared to placebo (median 1; IQR: 0 to 3; p = 0.049). The 12-week medication phase was completed by 87% (26/30) of subjects in the nicotine lozenge condition and 73% (22/30) of subjects in placebo (p = 0.33). At the end of the medication phase, lozenges were being used by 63% (19/30) of subjects in the nicotine lozenge group and 43% (17/30) of subjects in placebo.
3.3. Adverse Events
Adverse events were minimal. Heartburn was more common in the nicotine lozenge group (10% vs 0%) but sleep disturbance was more common in placebo (10% vs. 0%).
3.4. Nicotine Withdrawal and Tobacco Craving
Mean composite withdrawal score declined significantly with time (parameter estimate = −0.06, SE = 0.01, p < 0.001) and was lower for those receiving 4-mg lozenge versus placebo (estimate = −0.48, SE = 0.18, p = 0.033). The time-by-treatment interaction was not significant (estimate = +0.03, SE = 0.02, p = 0.084). Craving declined with time (estimate = −0.07, SE = 0.02, p < 0.001) but did not differ between treatment groups (estimate=+0.01, SE=0.28, p=0.961) and there was no evidence of a treatment-by-time interaction (estimate = −0.02, SE = 0.03, p = 0.420).
No statistically significant differences were observed between the two groups for any abstinence outcome at either 12 weeks (end-of-medication) or 6 months. At 12 weeks, the self-reported 7-day point prevalence all tobacco abstinence rate was 47% in the nicotine lozenge group compared to 37% in placebo (p = .432). At 12 weeks, point prevalence ST abstinence was 47% in the nicotine lozenge group and 37% in placebo (p = .432). Prolonged ST abstinence was 43% vs. 37% (p = .598). At 6 months, the self-reported point prevalence all tobacco abstinence rate was 30% in the nicotine lozenge group and 47% in placebo (p = .184). ST point prevalence abstinence rates at 6 months were 33% in the nicotine lozenge group and 47% in placebo (p = .292), and prolonged ST abstinence rates were 27% and 38% (p = .405), respectively.