Bupropion in Sexual Dysfunction Among Methadone Maintenance Treatment Men

NCT02593396 | Completed Phase 2 Results DMC

• 1 other identifier: AY001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

sexual dysfunctions; erectile dysfunctions; hypoactive sexual desire dysfunctions

Outcome Measures

Primary Outcomes (1)

• 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

  This scale assesses the changes of the sexual function. Scores range from 1 (normal/very much improved) to 7 (most extreme sexual dysfunction/very much worse). Lower scores indicate better sexual functioning.

  assessed at baseline, day 14(week 2), day 28(week four) and day 42 (week 6), data at day 42 (week 6) reported

Secondary Outcomes (2)

• Mean Difference of Malay Version of International Index of Erectile Function (Mal-IIEF-15) at Week 6 Between Placebo and Active Group

  assessed at baseline, day 14(week 2), day 28(week four) and day 42 (week 6), data at day 42 (week 6) reported

• Mean Difference of Malay Version of Sexual Desire Inventory 2 (SDI-2) Score at Weeks 6 Between Placebo and Active Groups

  Assessed at baseline, day 14(week 2), day 28(week four) and day 42 (week 6), data at day 42 (week 6) reported

Study Arms (2)

placebo

PLACEBO COMPARATOR

Placebo BD

Drug: placebo

Active

EXPERIMENTAL

Bupropion hydrochloride sustained-release 150mg BD

Drug: Bupropion hydrochloride sustained-release

Interventions

Bupropion hydrochloride sustained-release DRUG

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.).

Also known as: wellbutrin SR

Active

placebo DRUG

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)

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Medical Center

Kuala Lumpur, Selangor, 59100, Malaysia

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological; Erectile Dysfunction

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Mental Disorders; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Results Point of Contact

• Title: Dr. Anne Yee
• Organization: UNIVERSITY MALAYA

annyee17@um.edu.my

+60379492068

Study Officials

• Anne Yee

  University Malaya Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: November 2, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 1, 2019
• Results First Posted: July 12, 2019

Record last verified: 2019-07

Locations

MY (1)