Table 2.

Tobacco abstinence outcomes in a randomized clinical trial of the 4-mg nicotine lozenge for smokeless tobacco users

Abstinence definitiona	4-mg nicotine lozenge (n = 136)		Placebo (n = 134)		Logistic regression resultsb
	n	%	n	%	Odds ratio	95% CI	p value
Week 12 (end of medication)
Point prevalence
Self-report
Smokeless tobacco abstinence	69	50.7	46	34.3	2.0	1.2–3.2	.013
All tobacco abstinence	60	44.1	39	29.1	1.9	1.2–3.2	.011
Biochemically confirmedc
All tobacco abstinence	49	36.0	37	27.6	1.5	0.7–2.1	.138
Prolonged
Smokeless tobacco abstinence	65	47.8	41	30.6	2.1	1.3–3.4	.004
Week 24
Point prevalence
Self-report
Smokeless tobacco abstinence	43	31.6	35	26.1	1.3	0.8–2.2	.319
All tobacco abstinence	36	26.5	29	21.6	1.3	0.7–2.3	.345
Biochemically confirmed
All tobacco abstinence	34	25.0	24	17.9	1.5	0.8–2.8	.158
Prolonged
Smokeless tobacco abstinence	41	30.2	31	23.1	1.4	0.8–2.5	.194

Note. ^aPoint-prevalence abstinence is defined as no use within the past 7 days. Participants were classified as failing criteria for prolonged smokeless tobacco abstinence if they reported using smokeless tobacco on 7 consecutive days or at least once per week for 2 consecutive weeks following a 2-week grace period after the target quit date (Hughes et al., 2003). In all cases, participants who missed a visit were assumed to be using tobacco.

^bIn addition to treatment (nicotine vs. placebo), the logistic regression analysis included a covariate for study site. Odds ratios >1.0 indicate an increased likelihood of abstinence for active nicotine lozenge compared with placebo.

^cOf the 11 participants in the 4-mg nicotine lozenge group who failed biochemical confirmation at Week 12, 6 failed because of assay interference due to high concentrations of cotinine in the sample.