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IRCT2014032616823N1 IRCT 2014-03-26 Isfahan University of Medical Sciences-Behavioral Sciences Research Center Evaluation of Bupropion Efficacy on Sexual Dysfunction among Male Patients on Methadone Maintenance Therapy Evaluation of Bupropion Efficacy on Sexual Dysfunction among Male Patients on Methadone Maintenance Therapy 2009-09-23 anticipated 60 Complete https://irct.ir/trial/15610 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Sexual dysfunction. Intervention 1: intervention group- bupropion tab.100 mg Po for 3 days, then twice daily( 200mg/day) for 8 weeks. Intervention 2: control group: Placebo tab.100 mg po for 3 days, then twice daily( 200mg/day) for 8 weeks. http://www.tandfonline.com/doi/full/10.1080/14681994.2015.1016494#.VReV8_mUc9Y Decreased libido and sexual dysfunction (e.g., erectile dysfunction) seem to be the most common adverse effects of long-term methadone usage. To investigate the efficacy of bupropion on sexual dysfunction in men receiving methadone maintenance therapy (MMT), a double-blind, placebo-controlled trial was conducted in the addiction quitting center of Noor and St. Aliasghar Hospital of Isfahan. Sixty male patients receiving MMT for at least six months and having complaints of sexual dysfunction were randomized to treatment (n = 30) with bupropion (200 mg/day) or placebo (n = 30) for eight weeks. Sexual function and depression scores were assessed by Arizona sexual experience scale, and Beck depression inventory II self-reported questionnaires, respectively. The results showed that bupropion could improve sexual dysfunction (P = 0.006), but it showed no effect on depression severity scale (P > 0.05). Our findings suggest that adding bupropion to the current protocols of MMT could be useful in decreasing sexual dysfunction, thus it may result in more adherence to treatment and better outcome. Further studies with control group and greater sample size are warranted to evaluate the efficacy of bupropion on improvement of each phases of sexual function among MMT patients. RCT has been registered in http://irct.ir, code: IRCT2014032616823N1.
public Mehrdad Salehi
ostandari street- Noor & st. Aliasghar Hospital
Isfahan Iran (Islamic Republic of) +98 31 1222 2475 me_salehi@med.mui.ac.ir Behavioral Sciences Research Center- Isfahan University of Medical Sciences scientific Mehrdad Salehi
Ostandari street- Noor & st.Aliasghar Hospital
Isfahan Iran (Islamic Republic of) +98 31 1222 2475 me_salehi@med.mui.ac.ir Behavioral Sciences Reserach Center-Isfahan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Male gender;Having the minimum level of education in reading and writing; passing at least 6 months from the Methadone maintenance Therapy( MMT); Having complaints from the cause or aggravate of sexual dysfunction after methadone treatment; Lack of underlying diseases as epilepsy, diabetes, organic brain disease, and psychosis;Not receiving drugs affecting sexual function, such as SSRI, sildenafil, testosterone, antipsychotics, cyclic antidepressants, MAO-I, the lithium, amphetamines, chlordiazepoxide, clonidine, methyldopa, spironolactone hydrochlorothiazide, barbiturates, anti-Parkinson's drugs , clofibrate, digoxin, indomethacin, propranolol and phentolamine; No risk of major depressive disorder and a score of less than 16 based on the BDI-II, Having a total score of 19 or more based on the Arizona Sexual Experience Scale (ASEX) or a score of 5 or more on one of the items of ASEX or a score of 4 or more in any of 3 items; No alcohol consumption, recent cessation of benzodiazepines, and not using drugs or stimulants. Exclusion criteria: Leaving the MMT program; the decision of the therapist to stop the treatment with methadone or bupropion for any reason, and seizures. no limit no limit Male F52.0 Lack or loss of sexual desire Treatment - Drugs Treatment - Drugs intervention group- bupropion tab.100 mg Po for 3 days, then twice daily( 200mg/day) for 8 weeks. control group: Placebo tab.100 mg po for 3 days, then twice daily( 200mg/day) for 8 weeks. Sexual function. Timepoint: preintervention, post intervention at the end of 2, 4, 6,and 8 weeks. Method of measurement: Arizona sexual experiences scale(ASEX). Depression total score. Timepoint: preintervention, post intervention at the end of 2,4,6 and 8 weeks. Method of measurement: Beck depression scale. Isfahan University of Medical Sciences-Behavioral Sciences Research Center Approved 2009-06-09 Ethical commitee of Isfahan University of Medical Sciences Hezar Jarib street Isfahan Iran (Islamic Republic of)