LAUSR

BACKGROUND AND AIM One-third of United States (US) tobacco users are nondaily smokers (NDS). Blacks NDS have strikingly high levels of nicotine and carcinogen exposure. No smoking cessation studies have been conducted with this high-risk group. This study compared the effectiveness in black NDS of smoking cessation counseling alone or in combination with participant's choice of nicotine replacement therapy. DESIGN Two-arm parallel-group individually randomized clinical trial (allocation ratio of 2:1 intervention to control) SETTING: Academic medical and federally qualified health centers in 3 US cities PARTICIPANTS: Non-Hispanic black adult NDS receiving counseling with nicotine replacement therapy (C+NRT, n=185) or counseling alone (C, n=93). INTERVENTIONS Twelve weeks of in-person and telephone smoking cessation counseling in combination with nicotine replacement therapy [NRT; C+NRT] or counseling alone [C]. All participants received five sessions of counseling; those randomized to C+NRT received their choice of nicotine gum, patch, and/or lozenge after a 9-day product trial period. The target quit day was set at 2-weeks post-baseline for both groups. MEASUREMENTS Primary outcome was biochemically-verified 30-day abstinence at week 12. Secondary outcomes were change in nicotine and carcinogen exposure [4-(methynitrosamino) -1-(3) pyridyle-1-butanol; NNAL] and tobacco consumption patterns. FINDINGS Abstinence was 11.4% in C+NRT and 8.6% in C (OR=1.4, 95% CI=0.6, 3.2, p=0.48). Both groups experienced significant reduction in NNAL (C+NRT: 53% reduction, C: 50% reduction, within group p<.0001) but nonsignificant changes in cotinine (p=.69). C+NRT reported more days abstinent (p<.001) and fewer total cigarettes (p=.002) compared with C. There was no evidence of compensation with other tobacco products. CONCLUSIONS Among black nondaily smokers in the US, there was no difference in abstinence between nicotine replacement therapy (NRT) and counseling alone. NRT did lead to greater increase in days abstinent and reduction in cigarettes with no evidence of compensation from other sources of nicotine.