ObjectiveTo compare the efficacy and safety of acupuncture combined with auricular acupoints patches and nicotine transdermal patch in treating moderate to severe nicotine dependence. MethodsIn a rando-mized controlled trial， 64 quit smoking voluntary subjects with moderate to severe nicotine dependence were randomly divided at a ratio of 1∶1 into a treatment group and a control group， with 32 cases in each group. The treatment group was given acupuncture combined with auricular acupoints patches， twice weekly， four weeks as a course for two courses. The control group was given nicotine transdermal patch， one patch per day for 24 hours， 8 weeks. The cure rate was assessed after treatment and at follow-up （the 16th week after treatment）.The daily smoking volume， exhaled carbon monoxide （CO） value， Nicotine Dependence Scale （FTND）， Minnesota Nicotine Withdrawal Symptoms Scale （MNWS）， and Pittsburgh Sleepiness Index Inventory （PSQI） were evaluated before and after treatment and at follow-up， and adverse effects were recorded. ResultsIn terms of the cure rate， there were both six cured cases （20%） after treatment and at follow-up in the treatment group， while in the control group， seven （23.3%） and five （16.7%） patients were cured after treatment and at follow-up， respectively， with no statistically significant differences between the two groups both after treatment and at follow-up （P＞0.05）. The daily smoking volume and exhaled CO value significantly decreased after treatment and at follow-up in both groups （P＜0.05）， but were not significantly different between the groups after treatment and at follow-up （P＞0.05）. After treatment and at follow-up， FTND， MNWS， and PSQI scores were significantly reduced in both groups compared with those before treatment （P＜0.05）. There was no statistically significant difference in the FTND scale scores between the two groups after treatment and at follow-up （P＞0.05）， while the MNWS and PSQI scale scores were lower in the treatment group than in the control group （P＜0.05）. ConclusionAcupuncture combined with auricular acupoint patches for moderate to severe nicotine dependence has comparable effect with the first-line drug nicotine patch in terms of increasing the cure rate and decreasing the degree of nicotine dependence， and is superior to nicotine patch in terms of relieving withdrawal symptoms and improving sleep， with stable long-term effect.