Reimbursement of pharmacotherapy for smoking cessation in the context of brief general practitioner advice: A cluster-randomised pilot study in the HAFO.NRW primary care research network in Germany

ObjectiveThis study aimed to harness the potential of primary care for effective smoking cessation by piloting the effectiveness of providing free pharmacotherapy within the framework of brief general practitioner counseling. MethodsIn a cluster-randomised controlled pilot trial (cRCT) conducted in 2023-2024, 26 general practices from the research network HAFO.NRW were randomised. All patients received brief smoking cessation counseling by their general practitioner. Only in the intervention group was pharmacotherapy offered free of charge. The primary endpoint was self-reported tobacco abstinence after 12 weeks, biochemically validated by a carbon monoxide (CO) measurement performed in the general practice. ResultsA total of 129 patients from 13 intervention practices and 100 patients from 11 control practices were included. CO measurements were available for 58.1% of participants reporting abstinence. The odds ratio for CO-validated abstinence in the intervention versus control group was 1.07 (95% CI=0.25-4.58), and for self-reported abstinence 1.46 (95% CI=0.50-4.26). More patients in the intervention group used nicotine replacement therapy to support their quit attempt (81.4% vs. 56.1% in the control group), while more patients in the control group used e-cigarettes (27.3% vs. 17.6% in the intervention group). ConclusionOffering free pharmacotherapy in primary care appears feasible and may encourage the use of evidence-based cessation aids. These findings warrant further investigation in a confirmatory trial.