Phase 2
Completed N=80
Bupropion in Sexual Dysfunction Among Methadone Maintenance Treatment Men
Sexual Dysfunctions, Psychological · Hypoactive Sexual Desire Disorder · Erectile Dysfunctions
Source: ClinicalTrials.gov NCT02593396 ↗
Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Number of Participants With a Score of ≤2 (Much/Very Much Improved) on the Clinical Global Impression Scale Adapted for Sexual Function (CGI-SF) at Week 6 Between Placebo and Active Group — 10; 21 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Score of ≤2 (Much/Very Much Improved) on the Clinical Global Impression Scale Adapted for Sexual Function (CGI-SF) at Week 6 Between Placebo and Active Group |
10; 21 | — |
| SECONDARY Mean Difference of Malay Version of International Index of Erectile Function (Mal-IIEF-15) at Week 6 Between Placebo and Active Group |
43.81; 52.53; 18.06; 22.56; 5.99; 7.30 | — |
| SECONDARY Mean Difference of Malay Version of Sexual Desire Inventory 2 (SDI-2) Score at Weeks 6 Between Placebo and Active Groups |
47.36; 53.53; 29.99; 36.08; 6.87; 7.45 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02593396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.