Nicotine replacement therapy sampling for smoking cessation within primary care: results from a pragmatic cluster randomized clinical trial.

Background And Aims: Within the context of busy clinical settings, health-care providers need practical, evidence-based options to engage smokers in quitting. Sampling of nicotine replacement therapy [i.e. provision of nicotine replacement therapy (NRT starter kits)] is a brief, pragmatic strategy to address this need. We aimed to compare the effects of NRT sampling plus standard care (SC), relative to SC alone, provided by primary care providers during routine clinic visits.

Design: Cluster-randomized clinical trial.

Setting: Twenty-two primary care clinics in South Carolina, USA.

Participants: Adult smokers [n = 1245; 61% female, mean age = 50.7, standard deviation (SD) = 13.5] both motivated and unmotivated to quit, seen during routine clinical visit. Interventions were provider-delivered SC (n = 652, 12 clinics) cessation advice or SC + a 2-week supply of both nicotine patch and lozenge, with minimal instructions on use (n = 593; 10 clinics).

Measurements: The primary outcome was 7-day point prevalence smoking abstinence at 6-month follow-up, using intent-to-treat. Additional outcomes included NRT use and quit attempts, assessed at 1, 3 and 6 months following baseline.

Findings: Seven-day point prevalence abstinence rates were significantly higher in the NRT sampling group throughout follow-up, including at 6 months [12 versus 8%, odds ratio (OR) = 1.5, 95% confidence interval (CI) = 1.0-2.4]. NRT sampling increased prevalence of any use of NRT (65 versus 25%, OR = 5.8, 95% CI = 4.3-7.7), with higher prevalence of use at 6 months (25 versus 14%, OR = 2.0, 95% CI = 1.5-2.7). NRT sampling increased the rate of quit attempts in the initial month (24 versus 18%, OR = 1.5, 95% CI = 1.0-2.3) but had no significant effect on overall rate of quit attempts (48 versus 45%, OR = 1.2, 95% CI = 0.8-1.7).

Conclusion: Providing smokers with a free 2-week starter kit of nicotine replacement therapy increased quit attempts, use of stop smoking medications and smoking abstinence compared with standard care in a primary care setting.