Examining the role of freebase nicotine in the harm reduction potential of oral nicotine pouches versus moist snuff: A randomized crossover trial.
rct · Level II
Where this comes from
- Record sourced from PubMed, PMID 40598715.
- Also identified by DOI 10.1111/add.70114 and PMC identifier 12291100.
- Licence recorded as CC BY-NC-ND.
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Abstract
Oral nicotine pouches (ONPs) contain varying proportions of freebase nicotine (FBN), with higher FBN expected to increase nicotine delivery across the oral mucosa. Because ONPs contain fewer toxicants than moist snuff and may serve as a reduced harm alternative for smokeless tobacco, we compared how the FBN in ONPs affects both nicotine pharmacokinetics and craving relief relative to moist snuff. Three-visit (90-minute sessions; ≥48-hour washout), single-blind, randomized crossover study. Participants were asked to complete all visits within 1 month. Clinical facility in Columbus, Ohio, USA. N = 62 moist snuff users (M<sub>age</sub> = 41 years, 96.8% male, 91.9% white, 33.9% had tried ONPs before), recruited through social media advertisements and participants' word-of-mouth from rural and Appalachian Ohio. Following ≥12 hours of nicotine abstinence, participants used either a (1) low FBN peppermint ONP (27.4% FBN; 5.1 mg nicotine/pouch; Rogue brand), (2) high FBN peppermint ONP (70.2% FBN; 5.0 mg nicotine/pouch; Zyn brand) or (3) 2 g of usual brand moist snuff for 30 minutes. Participants completed the three study visits in one of six randomized orders. Plasma nicotine and self-reported craving were assessed at t = baseline, 5, 15, 30, 60 and 90 minutes. Plasma nicotine and craving relief at t = 30 minutes were primary and secondary outcomes, respectively. At t = 30 minutes, mean [standard deviation (SD)] plasma nicotine concentrations were 7.1 (2.8) ng/mL for low FBN ONP, 14.8 (6.4) ng/mL for high FBN ONP and 12.3 (8.4) ng/mL for moist snuff (all comparison Ps ≤ 0.001). Craving was lower for moist snuff (mean = 0.8) than either ONP (means = 1.4), with the low FBN ONP providing statistically significantly less craving relief than moist snuff (P < 0.001). The proportion of freebase nicotine in oral nicotine pouches appears to statistically significantly influence their nicotine delivery, with higher freebase nicotine oral nicotine pouches delivering more nicotine than usual brand moist snuff. However, craving appears to be higher when using oral nicotine pouches than usual brand moist snuff.