A Pilot Randomized Controlled Trial of a Non-pharmacological Smoking Cessation Program for Males with Chronic Obstructive Pulmonary Disease in Japan

Objective: Smoking cessation is considered the most reliable approach for preventing the worsening of chronic obstructive pulmonary disease (COPD). However, the majority of the previous studies on the effectiveness of non-pharmacologic smoking cessation support methods for people with COPD have been conducted in European and North American populations. This study aimed to fill a gap in the knowledge by focusing on the Japanese population.Material and Methods: This pilot randomized controlled trial included Japanese male participants aged above 50 years, diagnosed with COPD. Participants were allocated equally to the intervention group and the control group. The intervention group received a non-pharmacological cessation program developed in this study (twice online) in addition to outpatient smoking cessation at the collaborating institutions (5 visits in 12 weeks). The control group received only outpatient smoking cessation treatment at the collaborating medical institutions.Results: In total, 12 males (6 each in both groups) participated. No participants in the intervention group reported a tendency to smoke unconsciously, and none had resumed smoking. This suggests that the program was effective in helping participants maintain their motivation to quit smoking after the end of smoking cessation visits. Because of the small sample size, no statistically significant difference was observed in the smoking cessation rates between the 2 groups. However, the effect size between the 2 groups was large (Φ=0.517).Conclusion: The non-pharmacological cessation program developed in this study may be effective for males aged over 50 years with COPD in Japan.