The effect of Azaraghi herbal compound on craving, sexual function, mental health, and sleep quality in opioid-dependent patients under methadone maintenance therapy: a clinical trial

Ghaderi, َAmir; Razzaghi- Firozjaei, Farkhondeh; Zahiry- Pour, Amineh Sadat; Memarzadeh, Mohammad Reza; Mohammad-Taghizadeh- Kashani, Leila; Sadeghi, Akram; Bekhradi, Reza; Akbari, Hossein

doi:10.22038/ajp.2026.27576

The effect of Azaraghi herbal compound on craving, sexual function, mental health, and sleep quality in opioid-dependent patients under methadone maintenance therapy: a clinical trial

Articles in Press

Document Type : Original Research Article

Authors

¹ Department of Addiction Studies, School of Medical, Kashan University of Medical Sciences, Kashan, Iran

² Medicinal Plant Research Center of Barij, Kashan, Iran

³ Trauma Research Center, Department of Psychiatry, Kashan University of Medical Sciences, Kashan, Iran

⁴ Social Determinants of Health (SDH) Research Center, Department of Biostatistics and Epidemiology, School of Public Health, Kashan University of Medical Sciences, Kashan, Iran

10.22038/ajp.2026.27576

Abstract

Objective: Substance use disorders are chronic disorders that cause an imbalance of neurotransmitters. Conventional treatments often have limited efficacy and potential adverse effects, highlighting the need for adjunctive therapies. Herbal formulations such as Azaraghi Majoon (AM), rich in antioxidant and anti-inflammatory compounds, may offer therapeutic benefits. To evaluate the efficacy and safety of AM in reducing drug craving and improving psychological status, sexual function, and sleep quality in individuals with opioid dependence.
Materials and Methods: In this randomized, double-blind, placebo-controlled trial, 81 opioid-dependent patients on methadone maintenance therapy were randomly assigned to two groups: AM (n=40) or placebo (n=41). The herbal formulation was administered orally at 1–2 teaspoons/day, titrated to 4 teaspoons within one week, for four weeks. Methadone was continued at baseline doses, with up to 50% reduction allowed under supervision in improved patients. Primary outcomes were drug craving, depression, anxiety, and stress; secondary outcomes were sexual function and sleep quality. All outcomes were assessed at baseline, and week 2 and 4.
Results: AM significantly reduced drug craving compared to placebo (p<0.01), but improved depression, anxiety, stress, sexual function, and sleep quality (all p<0.01). No serious adverse effects or worsening of withdrawal symptoms were observed.
Conclusion: AM is a promising adjunctive therapy for opioid dependence, reducing craving, enhancing mood and sleep, improving sexual function, and demonstrating a favorable safety profile.

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