The Efficacy of Spirulina on Cognitive Function, Psychological and Clinical Indicators in Men Patients Under Methadone Therapy (a Randomized Trial)

ABSTRACT Patients undergoing methadone maintenance therapy (MMT) often experience psychological issues and clinical dysfunctions, which can negatively impact the effectiveness of the treatment. Addressing these challenges is crucial for improving patient outcomes. This clinical trials aimed to evaluate the effectiveness of Spirulina (SP) supplementation on craving, psychological distress, sexual performance, and cognitive functions in male receiving methadone. In this double‐blind randomized clinical trial, 50 male patients undergoing MMT were randomly assigned to receive either the SP (500 mg twice daily, n = 25) or the placebo ( n = 25) for 12 weeks. Assessments were conducted at baseline and at the end of the intervention. Psychological indicators were measured using the Depression, Anxiety, and Stress Scale‐21 (DASS‐21); sexual function was evaluated with the International Index for Erectile Function (IIEF); drug craving was assessed via the Drug Desire Questionnaire (DDQ); and cognitive performance was measured with the FAS test, Iowa Gambling Task (IGT), and Trail Making Test (TMT). Overall results support that SP supplementation significantly reduced anxiety and stress score compared to the placebo group ( p < 0.05). However, no significant effects were observed for the depression, sexual function, craving, and cognitive performance measures between the two groups ( p > 0.05). SP supplementation may help alleviate anxiety and stress in men undergoing MMT, suggesting its potential as a supportive intervention. Further studies with larger participant groups are warranted to confirm these effects and explore broader benefits of SP in this population. IRCT Registration IRCT20231101059923N2 (Registration date: 2023‐12‐16).