Nicotine replacement therapy sampling for cigarette cessation in dental care: A National Dental Practice‐Based Research Network cluster randomized clinical trial

BACKGROUND AND AIMS: Cigarette smoking is detrimental to oral health. Oral health professionals rarely prescribe smoking cessation medications. Nicotine replacement therapy sampling (NRTS), providing brief starter courses of NRT, could improve provision of NRT and promote cessation. The aim of the Free Samples for Health (FreSH) study was to test the effectiveness of NRTS compared with enhanced usual care on long-term abstinence from combustible tobacco. DESIGN: Two-group, pragmatic, cluster (dental practice) randomized clinical trial. SETTING: The study was conducted in the Midwest and Northeast nodes of the United States' National Dental Practice-Based Research Network in 59 dental practices. Practices were randomized to intervention condition. PARTICIPANTS: Participants (recruited June 2023-June 2025) were adult patients of network practices who smoke cigarettes daily [n = 1196; NRTS n = 486, comparison group (ET) n = 710; 59% female; 71% White]. INTERVENTION AND COMPARATOR: All participants received Ask-Advise-Refer: oral health practitioners asked smoking status, advised quitting and referred to state tobacco quitlines. Participants in the NRTS group were given a 2-week supply of 14 mg nicotine patches and 4 mg nicotine lozenges; participants in the ET group were given an electric toothbrush. MEASUREMENTS: Participants were surveyed after their visit and at 1, 3 and 6 months post enrollment. The primary outcome was 7-day point-prevalence abstinence measured 6 months post enrollment confirmed via expired breath carbon monoxide (CO) < 6 p.p.m. Secondary outcomes included quit attempts, short-term abstinence, NRT and quitline use. Covariates included stage of change, confidence, readiness and cigarettes per day. RESULTS: While there was no condition effect on CO-confirmed abstinence at 6 months post intervention [NRTS: 8.4%, ET: 8.0%; adjusted odds ratio (aOR) = 1.04, 95% confidence interval (CI) = 0.65-2.09], the NRTS intervention statistically significantly increased NRT use across all timepoints (NRTS: 50%, ET: 13%; aOR = 7.39, 95% CI = 5.29-10.31) and quit attempts at all timepoints (NRTS: 58%, ET: 49%; aOR = 1.46, 95% CI = 1.06-2.02). There was a statistically significant effect of NRTS on self-reported 7-day point-prevalence abstinence at 1 month post enrollment (NRTS: 12.8%, ET: 9.0%; aOR = 1.72, 95% CI = 1.03-2.88). There was no difference in quitline use. Practices assigned to the NRTS condition recruited notably fewer participants (t = 2.11, P = 0.04). SUMMARY: Free nicotine replacement therapy (NRT) samples are not sufficient to improve long-term smoking abstinence in dental patients; however, NRT samples increase engagement with quitting behaviors and may serve as a starting point toward quitting. Low recruitment in the NRT sampling group demonstrates discomfort by oral health practitioners in discussing smoking among those not voicing readiness to quit.