Effectiveness of a Single Auriculotherapy Session for Smoking Cessation: A Prospective, Randomized, Single-Blind, Superiority, Multicenter Trial

OBJECTIVE: Tobacco use is a leading cause of morbidity and mortality worldwide. Complementary therapies, such as auriculotherapy, are increasingly being explored for smoking cessation; however, inconsistent administration methods have limited definitive evidence. This study evaluated whether a single auriculotherapy session promotes smoking cessation. METHODS: In this multicenter, randomized, single-blind, superiority clinical trial conducted at a tertiary care university hospital and two private practices in France, we enrolled cigarette smokers aged ≥18 years who were motivated to quit. Participants were randomized into two groups using centralized computer-generated allocation: auriculotherapy (AUR) and sham auriculotherapy (SHAM). In the AUR group, specific ear points were treated with cryo-auriculotherapy (nitrous oxide gas applied for 2 sec). In the SHAM group, the same points were treated using an empty canister containing only a propellant gas. The participants were blinded to their group assignment. The primary outcome was the percentage of participants who achieved smoking cessation at 1 month, defined as a urinary cotinine level of <50 μg/L. Secondary outcomes included self-reported cessation, exhaled carbon monoxide levels, anxiety, depression, stress, weight gain, and auriculotherapy side effects. RESULTS: = 0.174). No significant adverse events or unintended effects were observed. CONCLUSION: A single cryo-auriculotherapy session did not significantly enhance smoking cessation compared with the sham session.