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

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 (F_{3, 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.