Male infertility in opioid substitution treatment. Male infertility
Conditions
Interventions
Intervention 1: According to a randomized categorization, participants will be classified in 2 groups that will be informed. In the intervention group methadone will be substitute with buprenorphine,
Treatment - Drugs
According to a randomized categorization, participants will be classified in 2 groups that will be informed. In the intervention group methadone will be substitute with buprenorphine, and maintenance
In the control group methadone will be continued as maintenance treatment for 6 months. prescribed medication in the control group is 5 mg methadone hydrochloride tablet, 40-60 mg/day, single dose, fo
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: men between 18 to 50 y/o; at least 6 months on Opioid Substitution Treatment & 3 months from last illegal opioid use; daily Methadone dose less than 60 mg/d; certification of therapist physician on stability & readiness of client for shifting from methadone to buprenorphine; diagnosis of methadone as the most important factor for undesirable hormonal & seminal analysis; written & signed informed consent form. Exclusion criteria: evidence or signs of laps & relapse in buprenorphine treatment even with appropriate dose; absence from treatment more than 2 consecutive or 3 undulant weeks; absence from screening opioid urine test more than 2 consecutive or 3 undulant sessions; absence from hormonal & seminal analysis more than 2 weeks after appointed time; intolerance of methadone dose reduction for shifting to buprenorphine; intolerance of buprenorphine side effects.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Follicle-stimulating hormone (FSH) blood level. Timepoint: Before intervention, 3 months after beginning of intervention, 6 months after beginning of intervention. Method of measurement: mIU/ml (ELISA).;Luteinizing hormone (LH) blood level. Timepoint: Before intervention, 3 months after beginning of intervention, 6 months after beginning of intervention. Method of measurement: IU/L (ELISA).;Free Testosterone (FT) blood level. Timepoint: Before intervention, 3 months after beginning of intervention, 6 months after beginning of intervention. Method of measurement: pg/ml (ELISA).;Total Testosterone (TT) blood level. Timepoint: Before intervention, 3 months after beginning of intervention, 6 months after beginning of intervention. Method of measurement: ng/ml (ELISA).;Prolactin (PRL) blood level. Timepoint: Before intervention, 3 months after beginning of intervention, 6 months after beginning of intervention. Method of measurement: ng/ml (ELISA).;Sex Hormone Binding Globulin (SHBG) blood level. Timepoint: Before intervention, 3 months after beginning of intervention, 6 months after beginning of intervention. Method of measurement: nmol/l (ELISA).;Semen Volume. Timepoint: Before intervention, 3 months after beginning of intervention, 6 months after beginning of intervention. Method of measurement: Ml.;Level of PH of semen. Timepoint: Before intervention, 3 months after beginning of intervention, 6 months after beginning of intervention. Method of measurement: Ph Scale.;Number of spermatozoid in 1 Ml of semen. Timepoint: Before intervention, 3 months after beginning of intervention, 6 months after beginning of intervention. Method of measurement: Million/ml.;Time for fluidity of semen. Timepoint: Before intervention, 3 months after beginning of intervention, 6 months after beginning of intervention. Method of measurement: minute.;Shape of spermatozoides. Timepoint: Before intervention, 3 months after beginning of intervention, 6 months after beginning of intervention. Me | — |
Secondary
| Measure | Time frame |
|---|---|
| Daily methadone dose. Timepoint: Before substitution by buprenorphine. Method of measurement: mg/d.;Daily buprenorphine dose. Timepoint: After substitution of methadone. Method of measurement: mg/d. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Reza Haddadi
Iranian National Center for Addiction Studies
Outcome results
None listed