Effects of oral nicotine pouches on cigarette smoking behaviour and tobacco harm exposure: a randomised pilot trial in adults

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Abstract
Oral nicotine pouches may have potential for smoking cessation, but scientific evidence on the effects of pouches and their constituents on smoking behaviour is limited.Design: This study was a 4-week, open-label, randomised pilot trial of nicotine pouches in 3 mg (low) or 6 mg (high) nicotine strength.Subjects: US outpatient research clinic with non-treatment seeking adults who smoke cigarettes (N=30).Interventions: Participants selected two flavours and were instructed to switch to using nicotine pouches in place of cigarettes.Main outcome measures: We compared groups on cigarettes smoked per day, pouch use and urinary levels of a tobacco-specific carcinogen (NNAL) over 4 weeks, biochemically verified 7-day point prevalence smoking abstinence at week 4, and willingness to continue pouch use.Results: Nearly all participants completed the trial (29/30). Participants in both groups significantly reduced their cigarettes smoked per day (log-transformed) over time (F3, 74.4=3.8, p=0.01). The 6 mg group reported numerically greater, but non-significant, reductions in smoking than the 3 mg group (least-square mean difference (LSMD) at week 1=0.008; 95% CI −0.42–0.44; LSMD at week 4=0.38; 95% CI −0.06–0.81). The 6 mg group also reported numerically higher, but non-significant, likelihood of complete smoking abstinence (13% vs 0%) and willingness to continue pouch use (67% vs 40%). There were no differences by group or time for NNAL.Conclusions: Results provide preliminary support for nicotine pouches for cigarette substitution. Compared with lower nicotine strength pouches, higher nicotine strength pouches may have a greater impact on smoking behaviour and adults who smoke may be more willing to use them.Trial registration number: NCT04250727.
Funding Information
  • Center for Tobacco Products (U54DA036151)
  • National Institute on Drug Abuse (K23DA045957)

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