Phase 2 N=80 Randomized Quadruple-blind Treatment

Bupropion in Sexual Dysfunction Among Methadone Maintenance Treatment Men

Sexual Dysfunctions, Psychological · Hypoactive Sexual Desire Disorder · Erectile Dysfunctions

Bottom Line

View on ClinicalTrials.gov: NCT02593396 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2019

Primary outcome: 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 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Bupropion hydrochloride sustained-release (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: University of Malaya
Primary completion: Dec 2017

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	—

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.

View full record on ClinicalTrials.gov →

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.