Opioid Use Disorder (OUD) - men receiving Methadone Maintenance Treatment (MMT). Opioid dependence
Conditions
Interventions
Intervention 1: Intervention group: Oral melatonin 10 milligrams (tablet), one nightly for 4 weeks
manufacturer: Jalinous Pharmaceutical Co. (Iran). Methadone maintenance treatment continues unchanged. Intervention 2: Control group: No additional medication
methadone maintenance treatment only, unchanged.
Sponsors
Gorgan University of Medical Sciences
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Men aged 18 to 50 years Able to read and write Diagnosed opioid use disorder On methadone maintenance treatment for at least 3 months Willing to participate (written informed consent) Sexually active within the past 4 weeks Married
Exclusion criteria
Exclusion criteria: Unwillingness to continue participation history of hypersensitivity to melatonin current psychiatric disorder or use of psychotropic medications chronic medical illness or use of chronic medications self-reported severe sexual dysfunction; use of any medication other than methadone including drugs that may affect sexual function such as antidepressants, antipsychotics, benzodiazepines, and certain antihypertensives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in IIEF-15 total score from baseline to Week 4. Timepoint: Baseline before the first dose/on Day 0 , End of intervention at Week 4 (±3 days) after intervention start. Method of measurement: International Index of Erectile Function, fifteen item version questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactVida Sadani
Gorgan University of Medical Sciences
Outcome results
None listed