Bupropion in Sexual Dysfunction Among Methadone Maintenance Treatment Men
Condition: Sexual Dysfunctions, Psychological; Hypoactive Sexual Desire Disorder; Erectile Dysfunctions
MeSH terms: Hypokinesia; Erectile Dysfunction; Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the tolerability, safety, and efficacy of bupropion
      hydrochloride sustained-release in the treatment of sexual dysfunction in men on methadone
      maintenance therapy.
    

Detailed description: 
      This is a single-center (University Malaya Medical Centre), randomized, double-Blind,
      placebo-controlled versus bupropion hydrochloride sustained-releases study trial on 70 men
      who have methadone emergent sexual dysfunction. Bupropion hydrochloride sustained-release
      (Wellbutrin SR) 150mg once a day for 7 days then 150mg twice a day for 42 days. Taken orally
      by the subjects.The total duration of the study is expected to be 24 months. 20months for
      subject recruitment and 4 months for final subject follow-up.

      The primary endpoint is Mean improvement in scores on the Clinical Global Impression Scale
      adapted for sexual Function (CGI-SF). Secondary endpoints are Change from baseline
      International Index of Erectile Function (IIEF-15) score. Mean improvement in scores on the
      sexual desire inventory 2 (SDI2). Other evaluation included: Montgomery-Åsberg Depression
      Rating Scale (MADRS- Malay version ), Mini International Neuropsychiatric Interview
      (M.I.N.I), Opiate Treatment Index (OTI), World health organization Quality of Life-Brief
      Scale (WHOQoL-Brief, Malay version), Malay Version of the Golombok-Rust Inventory of Marital
      State (Mal-GRIMS) and Rapid urine drug test. Safety evaluation included: Incidence of adverse
      events. Data will be analyzed using linear mixed-effects model.
    

Intervention name(s): Bupropion hydrochloride sustained-release; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Up to 70 eligible patients will be randomly assigned to Bupropion Hydrochloride Sustained-Release or placebo treatment groups in a 1:1 ratio using a computer-generated table of random numbers through the use of the Randomization.com program. Subjects will be randomized to to Bupropion Hydrochloride Sustained-Release 150mg b.d. (n = 35) or placebo b.d (n = 35)The study drug will be repacked in the standard capsules by the research assistant who is not involved in the assessment of the study. The study drug and placebo will be packaged in sets of 11 (1 tablet per day for 3 days, followed by 2 tablets per day for 4 days.) for the first week. Subsequently, the study drug and placebo will be packaged in sets of 14 (2 tablets per day for 7 days.).; Up to 70 eligible patients will be randomly assigned to Bupropion Hydrochloride Sustained-Release or placebo treatment groups in a 1:1 ratio using a computer-generated table of random numbers through the use of the Randomization.com program. Subjects will be randomized to to Bupropion Hydrochloride Sustained-Release 150mg b.d. (n = 35) or placebo b.d (n = 35)
Other intervention name(s): wellbutrin SR
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sexual dysfunctions; erectile dysfunctions; hypoactive sexual desire dysfunctions