BACKGROUND-AIM:
Smokers experiencing socioeconomic disadvantage are underrepresented in cessation trials, despite a marked social gradient in smoking. The STOP trial (Smoking Cessation Using Preference-Based Tools) evaluated a preference-based intervention offering free nicotine replacement therapy (NRT) and/or electronic cigarettes (e-cigarettes), through healthcare professionals.

METHODS:
STOP is a pragmatic, multicenter, single-blind, intent-to-treat, parallel-group randomized controlled trial. From March 2021 to March 2024, participants were recruited in 17 health centers across 15 French cities. A total of 170 low-income smokers, smoking at least 5 cigarettes per day, and willing to reduce or quit smoking, were randomized to the intervention (N=85) or control group (N=85). Participants randomized to the intervention group received free cessation aids (NRT and/or e-cigarettes) according to their preference, alongside routine care at each visit (10 days, 1 month, 3 month and 6 months and beyond). In the control group, participants received standard counseling and prescriptions as per usual practice. The primary outcome was self-reported abstinence assessed at 6-months and beyond. Secondary outcomes included smoking reduction (≥50% decrease or cessation), at least one quit attempt, use of NRT or e-cigarettes, and the number of cigarettes smoked per day at 6 months and beyond. We estimated relative risks (RRs) and 95% confidence intervals (CIs) using log-binomial regression for all binary outcomes. This trial was registered on ClinicalTrials.gov (Identifier: NCT04654585) and has been completed.

RESULTS:
Most participants were 40 years or older (75%) and male (52%). At baseline, they smoked an average of 19 cigarettes per day. After 6 months, abstinence was slightly higher in the intervention group (n=49) compared to the control group (n=53), but the difference was not statistically significant (31% vs. 24%; RR=1.18; 95% CI: 0.62–2.21). Both groups reduced their cigarette consumption, respectively 65% of participants in the intervention and 51% in the control group (RR=1.21; 0.87 to 1.68). E-cigarette use was higher in the intervention group, while NRT use did not differ significantly between groups.

CONCLUSIONS:
Despite receiving free cessation aids, the intervention group showed comparable quit rates, smoking reduction, and NRT use to the control group. However, the higher uptake of e-cigarettes and the trend toward greater abstinence and reduction suggest potential benefits not captured by statistical significance likely due to the limited sample size. These findings likely reflect the context of the French public healthcare system, where access to smoking cessation support is already relatively widespread. In such settings, enhancing personalized support may be as important as expanding free access, with preference-based tools offering added value for certain smokers.