Back to resultsBupropion in Sexual Dysfunction Among Methadone Maintenance Treatment Men
Primary Purpose
Sexual Dysfunctions, Psychological, Hypoactive Sexual Desire Disorder, Erectile Dysfunctions
Status
Completed
Phase
Phase 2
Locations
Malaysia
Study Type
Interventional
Intervention
Bupropion hydrochloride sustained-release
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sexual Dysfunctions, Psychological focused on measuring sexual dysfunctions, erectile dysfunctions, hypoactive sexual desire dysfunctions
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.
Sites / Locations
- University Malaya Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
placebo
Active
Arm Description
Placebo BD
Bupropion hydrochloride sustained-release 150mg BD
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Mean Difference of Malay Version of International Index of Erectile Function (Mal-IIEF-15) at Week 6 Between Placebo and Active Group
Mal-IIEF-15 is a 15-item, multi-dimensional self-reporting instrument for the evaluation of male sexual function for the past 4 weeks, consisted of five domains; 1) Erectile Function: sum of items 1, 2, 3, 4, 5 & 15. Total score range =1-30. 2) Orgasmic Function: sum of items 9 and 10. Total score range = 0 -10. 3) Sexual Desire: sum of items 11 and 12. Total score range = 2 -10. 4) Intercourse Satisfaction : sum of scores for Questions 6, 7 and 8. Total score range = 0 -15. 5) Overall Satisfaction: sum of items 13 and 14.Total score range = 2 -10. Items 1-10 is 6-point Likert-type scale from '0' (= No sexual activity) to '5' (= Almost always or always). Items 11-15 is 5-point Likert-type scale from '1' (= Almost never or never) to '5 '(= 'Almost always or always').The total Mal-IIEF-15 range from 5 (minimum) to 75 (Maximum). Higher score indicates better outcome in all domain.
Mean Difference of Malay Version of Sexual Desire Inventory 2 (SDI-2) Score at Weeks 6 Between Placebo and Active Groups
This scale contains 14 items which yield two domain scores: dyadic sexual desire (DSD) and solitary sexual desire (SSD). Items 1,2, 10, 14 are 8-point Likert scale from '0' (= not at all) to '7' (= more than once a day) concerning frequency of desire. Remaining Items are 9-point Likert scale from '0' (= 'no desire') to '8' (= 'strong desire'). DSD has 8 items and SSD has 3 items. The total sores for DSD range from 0 to 62, and SSD, range from 0 to 23. All items are summed up to dictate the total sexual desire (total score = 0 to 112). Higher scores reflect higher sexual desire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02593396
Brief Title
Bupropion in Sexual Dysfunction Among Methadone Maintenance Treatment Men
Official Title
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial Of Bupropion Hydrochloride Sustained-Release In The Treatment Of Sexual Dysfunction In Men On Methadone Maintenance Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Malaya
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunctions, Psychological, Hypoactive Sexual Desire Disorder, Erectile Dysfunctions
Keywords
sexual dysfunctions, erectile dysfunctions, hypoactive sexual desire dysfunctions
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo BD
Arm Title
Active
Arm Type
Experimental
Arm Description
Bupropion hydrochloride sustained-release 150mg BD
Intervention Type
Drug
Intervention Name(s)
Bupropion hydrochloride sustained-release
Other Intervention Name(s)
wellbutrin SR
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.).
Intervention Type
Drug
Intervention Name(s)
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)
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
assessed at baseline, day 14(week 2), day 28(week four) and day 42 (week 6), data at day 42 (week 6) reported
Secondary Outcome Measure Information:
Title
Mean Difference of Malay Version of International Index of Erectile Function (Mal-IIEF-15) at Week 6 Between Placebo and Active Group
Description
Mal-IIEF-15 is a 15-item, multi-dimensional self-reporting instrument for the evaluation of male sexual function for the past 4 weeks, consisted of five domains; 1) Erectile Function: sum of items 1, 2, 3, 4, 5 & 15. Total score range =1-30. 2) Orgasmic Function: sum of items 9 and 10. Total score range = 0 -10. 3) Sexual Desire: sum of items 11 and 12. Total score range = 2 -10. 4) Intercourse Satisfaction : sum of scores for Questions 6, 7 and 8. Total score range = 0 -15. 5) Overall Satisfaction: sum of items 13 and 14.Total score range = 2 -10. Items 1-10 is 6-point Likert-type scale from '0' (= No sexual activity) to '5' (= Almost always or always). Items 11-15 is 5-point Likert-type scale from '1' (= Almost never or never) to '5 '(= 'Almost always or always').The total Mal-IIEF-15 range from 5 (minimum) to 75 (Maximum). Higher score indicates better outcome in all domain.
Time Frame
assessed at baseline, day 14(week 2), day 28(week four) and day 42 (week 6), data at day 42 (week 6) reported
Title
Mean Difference of Malay Version of Sexual Desire Inventory 2 (SDI-2) Score at Weeks 6 Between Placebo and Active Groups
Description
This scale contains 14 items which yield two domain scores: dyadic sexual desire (DSD) and solitary sexual desire (SSD). Items 1,2, 10, 14 are 8-point Likert scale from '0' (= not at all) to '7' (= more than once a day) concerning frequency of desire. Remaining Items are 9-point Likert scale from '0' (= 'no desire') to '8' (= 'strong desire'). DSD has 8 items and SSD has 3 items. The total sores for DSD range from 0 to 62, and SSD, range from 0 to 23. All items are summed up to dictate the total sexual desire (total score = 0 to 112). Higher scores reflect higher sexual desire.
Time Frame
Assessed at baseline, day 14(week 2), day 28(week four) and day 42 (week 6), data at day 42 (week 6) reported
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Yee
Organizational Affiliation
University Malaya Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Malaya Medical Center
City
Kuala Lumpur
State/Province
Selangor
ZIP/Postal Code
59100
Country
Malaysia
12. IPD Sharing Statement
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Bupropion in Sexual Dysfunction Among Methadone Maintenance Treatment Men
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