Bupropion in Sexual Dysfunction Among Methadone Maintenance Treatment Men

University of Malaya

Status and phase

Completed

Phase 2

Conditions

Hypoactive Sexual Desire Disorder

Erectile Dysfunctions

Sexual Dysfunctions, Psychological

Treatments

Drug: placebo

Drug: Bupropion hydrochloride sustained-release

Study type

Interventional

Funder types

Other

Identifiers

NCT02593396

AY001

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.