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Bupropion in Sexual Dysfunction Among Methadone Maintenance Treatment Men

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ClinicalTrials.gov Identifier: NCT02593396
Recruitment Status : Recruiting
First Posted : November 2, 2015
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
University of Malaya

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.

Condition or disease Intervention/treatment Phase
Sexual Dysfunctions, Psychological Hypoactive Sexual Desire Disorder Erectile Dysfunctions Drug: Bupropion hydrochloride sustained-release Drug: placebo Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2015
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: placebo
Placebo BD
Drug: placebo
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)
Experimental: Active
Bupropion hydrochloride sustained-release 150mg BD
Drug: Bupropion hydrochloride sustained-release
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.).
Other Name: wellbutrin SR



Primary Outcome Measures :
  1. Change from baseline in Clinical Global Impression Scale adapted for Sexual Function at (CGI-SF)-at 2,4,6. [ Time Frame: at the baseline, day 14(week 2), day 28(week four) and day 42 (week 6) ]

Secondary Outcome Measures :
  1. Change From Baseline in International Index of Erectile Function (IIEF) score at Weeks 2, 4 and 6 [ Time Frame: at the baseline, day 14(week 2), day 28(week four) and day 42 (week 6) ]
  2. Change from baseline in the individual domain scores: erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall sexual satisfaction, of the IIEF at weeks 2, 4, 6 [ Time Frame: at the baseline, day 14(week 2), day 28(week four) and day 42 (week 6) ]
    IIEF includes 5 relevant domains of male sexual function :1/ Orgasmic Function Domain was sum of scores for Questions 9 and 10 from the IIEF. Score range: 0 to 5; total 0 to 10. 2/ Sexual Desire Domain was sum of scores for Questions 11 and 12 from the IIEF. Score range: 1 to 5; total 2 to 10. 3/ EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. .4/.Intercourse Satisfaction Domain: sum of scores for Questions 6, 7 and 8 from IIEF. Score range: 0 to 5; total 0 to 15. 5/Overall Satisfaction Domain was sum of scores for Questions 13 and 14 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome in all domain.

  3. Change from baseline in sexual desire inventory 2 (SDI2) score at weeks 2, 4,6, [ Time Frame: at the baseline, day 14(week 2), day 28(week four) and day 42 (week 6) ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593396


Contacts
Contact: Anne Dr Yee, MPM +60379494327 annyee17@um.edu.my
Contact: Hatim Dr Sulaiman, PHD +60379492068 hatim@um.edu.my

Locations
Malaysia
University Malaya Medical Center Recruiting
Kuala Lumpur, Selangor, Malaysia, 59100
Contact: Anne Yee       annyee17@um.edu.my   
Contact: Hatim Sulaiman       hatim@um.edu.my   
Sponsors and Collaborators
University of Malaya
Investigators
Principal Investigator: Anne Yee University Malaya Medical Center

Responsible Party: University of Malaya
ClinicalTrials.gov Identifier: NCT02593396     History of Changes
Other Study ID Numbers: AY001
First Posted: November 2, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

Keywords provided by University of Malaya:
sexual dysfunctions
erectile dysfunctions
hypoactive sexual desire dysfunctions

Additional relevant MeSH terms:
Erectile Dysfunction
Hypokinesia
Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Genital Diseases, Male
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bupropion
Methadone
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents