Methadone and Buprenorphine have been used as opioid Substitution Treatment (OST) in the world since 40 & 18 years ago in order. Regardless of short period experience in the past, these treatments have 14 & 10 years history in Iran respectively. There is a lot of questions about unwanted side effects of these medications on structure & function of different organs of body which concerns clients & worries therapists. One of organs with most sensitivity about that, is Genital system and common questions of mostly young clients on maintenance treatments, especially those who tend to have child in the future, is about probable effects of methadone & buprenorphine on sperm & fertility. Accurate & scientific answer to this question and select of appropriate medication for each client, diminishes their concerns and increases therapeutic alliance. According to high prevalence & morbidity of opioid use disorder especially in young & middle-aged men, and widespread providing of OST with methadone & buprenorphine, we decided to substitute methadone by buprenorphine in men who receive OST and survey the effect of this shift on sexual hormones & sperm analysis.
The study will be done on 40 participants from Rouyan institute who their infertility has been established and in the routine diagnostic procedures, there was not any finding except methadone consumption as an opioid substitution treatment. Primary routine laboratory tests (including TT, FT, LH, FSH, SHBG, PL, Semen Analysis) will done in the Rouyan Institute and after filling of inclusion criteria, clients will be refer to an experienced clinic in prescription of buprenorphine with appropriate access for continuing of study.
Inclusion criteria: 1) men between 18 to 50 y/o; 2) at least 6 months on Opioid Substitution Treatment & 3 months from last illegal opioid use; 3) daily Methadone dose less than 60 mg/d; 4) certification of therapist physician on stability & readiness of client for shifting from methadone to buprenorphine; 5) diagnosis of methadone as the most important factor for undesirable hormonal & seminal analysis; 6) written & signed informed consent form.
The participants will stay on 2 groups randomly. In the study group methadone will be substituted with buprenorphine and in the control group methadone will be continued. In both groups laboratory test including sex hormones (TT, FT, LH, FSH, SHBG, PL) and semen analysis will be done 3 times: before intervention,3 months & 6 months after beginning of intervention.
Exclusion criteria: 1) evidence or signs of laps & relapse in buprenorphine treatment even with appropriate dose; 2) absence from treatment more than 2 consecutive or 3 undulant weeks; 3) absence from screening opioid urine test more than 2 consecutive or 3 undulant sessions; 4) absence from hormonal & seminal analysis more than 2 weeks after appointed time; 5) intolerance of methadone dose reduction for shifting to buprenorphine; 6) intolerance of buprenorphine side effects.