The Role of Melatonin in Smoking Cessation and COPD Management: A Randomized Controlled Trial.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a leading global health concern, characterized by persistent airflow obstruction and a significant burden on quality of life. Smoking cessation is critical for COPD management, but nicotine addiction poses challenges. Emerging evidence suggests that melatonin may aid in addiction management, though its efficacy in COPD remains underexplored. METHODS: This randomized, triple-blind, controlled clinical trial evaluated the impact of melatonin on nicotine dependence and COPD outcomes over 180 days. Sixty male COPD patients with a history of smoking were randomized to receive melatonin (5 mg or placebo). Smoking behavior, psychological well-being, and hospitalization rates were assessed using validated scales. RESULTS: Both groups exhibited reduced cigarette consumption and improved psychological scores over time, with no significant differences between groups. Hospitalization rates due to COPD exacerbations were lower in the melatonin group (4% vs. 24% in placebo), indicating a nonsignificant trend that warrants further investigation, although the difference was not statistically significant. CONCLUSION: While melatonin did not significantly affect smoking cessation or psychological outcomes, the observed reduction in hospitalization rates should be interpreted cautiously as an exploratory finding. Larger, long-term, and adequately powered studies are needed to confirm these results and further investigate the potential role of melatonin as an adjunct therapy in COPD management. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT): IRCT20190810044500N25.