Investigating the effect of saffron extract on sex hormones and sexual dysfunction in opioid-dependent men undergoing maintenance treatment with methadone, opium tincture and voluntary withdrawal

Phase 3

Not yet recruiting

• Conditions: Opioid dependent men undergoing maintenance treatment with methadone, opium tincture and voluntary withdrawal.

• Registration Number: IRCT20240311061254N1
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-05-27

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: 240

Inclusion Criteria

The entry of married men knowingly, without coercion and freely, who are literate and literate, will participate in this study by filling and signing a written consent form, and they are psychologically and cognitively healthy, aware and alert. Active use of opioid substances for at least 5 years before the study and people receiving methadone or opium tincture have been under maintenance treatment with methadone or opium tincture for at least 1 year. According to the sexual disorders questionnaire, have sexual problems with a minimum score (average). Patients' evaluation: all the relevant information will be available in accordance with the ethical principles in maintaining and trusting the identity of the patients. 1- Personal characteristics: name, surname, father's name, ID number, place of birth, date of birth 2- Basic demographic characteristics: gender, marital status, level of education, occupation, weight, height, level of physical activity, race (native or not) 3- The type of narcotic used by the patients 4- Determining the dosage and duration of the narcotic in the past months 5- Examining the previous treatment history of the patients in the field of addiction, including outpatient methods, hospitalization, self-medication, staying in camps and camps etc. 6- History of sexual problems, including late or early ejaculation, dysfunction of erectile function, decreased sexual desire, sexual behavior problems, general dissatisfaction with sexual relations 7- History of prison 8- History of physical and special diseases

Exclusion Criteria

All patients who have severe anxiety, depression, stress, mental disorders (suicidal thoughts and withdrawal, dementia, autism, mental retardation, psychosis, bipolar disease, etc.) and have cardiovascular, kidney, liver, lung, thyroid, diabetes, Gastrointestinal diseases, blood pressure, all types of cancer and infectious diseases and AIDS, and they also have drug sensitivity, plant allergies, autoimmune diseases, sexual problems and congenital reproductive system, and taking medicine is harmful for them. They have absolute prohibition conditions.

Study & Design

• Study Type: interventional
• Study Design: Not specified