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
Intervention: Bupropion hydrochloride sustained-release; placebo
Intervention description: 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)
Intervention MeSH terms: Bupropion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: sexual dysfunctions; erectile dysfunctions; hypoactive sexual desire dysfunctions

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Had a diagnosis of opioid dependence base on Diagnostic and Statistical Manual of
             Mental Disorders, Fourth Edition (DSM-IV) criteria

          -  While taking a stable dose of methadone In UMMC (University Malaya Medica Centre) and
             University Malaya centre of Addiction Science (UMCAS) outpatient clinic for ≥ 6 months

          -  Were experiencing constant sexual dysfunction for ≥ 4 weeks

          -  Were in a stable sexual relationship with a female partner for ≥ 6 months

        Exclusion Criteria:

          -  Severe behavior disturbances or psychotic symptoms

          -  Obvious organic illnesses caused the sexual dysfunction (such as diabetics or patients
             with heart and vascular disease)

          -  Those with history of sexual dysfunction before methadone therapy

          -  Receiving antiviral treatment for viral hepatitis or HIV, or androgen replacement
             treatment.

          -  History of an eating disorder (eg, anorexia, bulimia) or seizures (eg, epilepsy)

          -  Using other psychotropic medications other than methadone

          -  Clinical significant abnormal laboratory values.

          -  Clinically significant abnormal ECG. Documented history of other psychiatric diagnosis
             (schizophrenia, bipolar disorder, major depressive disorder, organic brain disorder,
             dementia etc.)

          -  Refused to give participate.