INTRODUCTION: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). DISCUSSION: 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.
RCT Entities:
INTRODUCTION: 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). DISCUSSION: 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.
Authors: Saul Shiffman; Carolyn M Dresler; Peter Hajek; Simon J A Gilburt; Darren A Targett; Kenneth R Strahs Journal: Arch Intern Med Date: 2002-06-10
Authors: John R Hughes; Josue P Keely; Ray S Niaura; Deborah J Ossip-Klein; Robyn L Richmond; Gary E Swan Journal: Nicotine Tob Res Date: 2003-02 Impact factor: 4.244
Authors: Thomas P Moyer; Joel R Charlson; Robert J Enger; Lowell C Dale; Jon O Ebbert; Darrell R Schroeder; Richard D Hurt Journal: Clin Chem Date: 2002-09 Impact factor: 8.327
Authors: Herbert H Severson; Brian G Danaher; Jon O Ebbert; Nora van Meter; Edward Lichtenstein; Chris Widdop; Ryann Crowley; Laura Akers; John R Seeley Journal: Nicotine Tob Res Date: 2014-08-28 Impact factor: 4.244
Authors: Jon O Ebbert; Ivana T Croghan; Herbert H Severson; Darrell R Schroeder; J Taylor Hays Journal: Nicotine Tob Res Date: 2011-04-18 Impact factor: 4.244
Authors: Brian G Danaher; Herbert H Severson; Shu-Hong Zhu; Judy A Andrews; Sharon E Cummins; Edward Lichtenstein; Gary J Tedeschi; Coleen Hudkins; Chris Widdop; Ryann Crowley; John R Seeley Journal: Internet Interv Date: 2015-05-01
Authors: Raka Jain; Sonali Jhanjee; Veena Jain; Tina Gupta; Swati Mittal; Patricia Goelz; E Paul Wileyto; Robert A Schnoll Journal: Nicotine Tob Res Date: 2013-08-14 Impact factor: 4.244