Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial of Bupropion as Treatment for Methadone-Emergent Sexual Dysfunction in Men
Methadone is largely recognized as an effective treatment for opiate-dependent patients; however, it causes reduced brain dopaminergic action resulting in significant sexual dysfunction. Bupropion is a dopamine reuptake inhibitor which can potentially improve erectile function among male patients on...
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Published: |
SAGE Publications
2018
|
| Subjects: |
| _version_ | 1825721466934525952 |
|---|---|
| author | Yee, Anne Loh, Huai Seng Ong, Teng Aik Ng, Chong Guan Sulaiman, Ahmad Hatim |
| author_facet | Yee, Anne Loh, Huai Seng Ong, Teng Aik Ng, Chong Guan Sulaiman, Ahmad Hatim |
| author_sort | Yee, Anne |
| collection | UM |
| description | Methadone is largely recognized as an effective treatment for opiate-dependent patients; however, it causes reduced brain dopaminergic action resulting in significant sexual dysfunction. Bupropion is a dopamine reuptake inhibitor which can potentially improve erectile function among male patients on methadone (MMT). This is a phase II, randomized, double-blind, parallel-group, placebo-controlled trial, involving 80 MMT male patients (73.4%) with mean age of 42.83 years ±9.68. These MMT male patients were randomly assigned into two groups to receive bupropion and placebo, respectively. The primary efficacy outcome measure was the difference between the two groups in end-point mean improvement scores using the measurement of Clinical Global Impression Scale adapted for Sexual Function (CGI-SF) at baseline (week 0) and at weeks 2, 4, and 6. Malay version of the sexual desire inventory-2 (SDI-2-BM) and Malay version of International Index of Erectile Function 15 (Mal-IIEF-15) domain scores were evaluated as secondary parameters. Improvement of the end-point mean from baseline were seen across the scores of SDI-2-BM (mean difference = 11.77 ± 2.90, 95% confidence interval (CI) [3.89, 19.54], p <.001) and Mal-IIEF-15 (mean difference = 8.37 ± 2.71, 95% CI [15.75, 0.99], p =.02), and the total plasma testosterone level (mean difference = 4.03, 95% CI [0.90, 7.15], p =.01). A categorical improvement of “much/very much improved” (CGI-SF score = 2) was reported by 58.3% (n = 21/36) of bupropion SR-assigned versus 27.7% (n = 10/36) placebo-assigned patient. Bupropion was well tolerated with no serious adverse events reported other than insomnia (17.7%). Six weeks of bupropion SR treatment reported significant improvement in key aspects of sexual function among male opiate-dependent patients on methadone maintenance treatment with emergent sexual dysfunction. |
| first_indexed | 2024-03-06T05:50:45Z |
| format | Article |
| id | um.eprints-20283 |
| institution | Universiti Malaya |
| last_indexed | 2024-03-06T05:50:45Z |
| publishDate | 2018 |
| publisher | SAGE Publications |
| record_format | dspace |
| spelling | um.eprints-202832019-02-13T04:33:50Z http://eprints.um.edu.my/20283/ Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial of Bupropion as Treatment for Methadone-Emergent Sexual Dysfunction in Men Yee, Anne Loh, Huai Seng Ong, Teng Aik Ng, Chong Guan Sulaiman, Ahmad Hatim R Medicine Methadone is largely recognized as an effective treatment for opiate-dependent patients; however, it causes reduced brain dopaminergic action resulting in significant sexual dysfunction. Bupropion is a dopamine reuptake inhibitor which can potentially improve erectile function among male patients on methadone (MMT). This is a phase II, randomized, double-blind, parallel-group, placebo-controlled trial, involving 80 MMT male patients (73.4%) with mean age of 42.83 years ±9.68. These MMT male patients were randomly assigned into two groups to receive bupropion and placebo, respectively. The primary efficacy outcome measure was the difference between the two groups in end-point mean improvement scores using the measurement of Clinical Global Impression Scale adapted for Sexual Function (CGI-SF) at baseline (week 0) and at weeks 2, 4, and 6. Malay version of the sexual desire inventory-2 (SDI-2-BM) and Malay version of International Index of Erectile Function 15 (Mal-IIEF-15) domain scores were evaluated as secondary parameters. Improvement of the end-point mean from baseline were seen across the scores of SDI-2-BM (mean difference = 11.77 ± 2.90, 95% confidence interval (CI) [3.89, 19.54], p <.001) and Mal-IIEF-15 (mean difference = 8.37 ± 2.71, 95% CI [15.75, 0.99], p =.02), and the total plasma testosterone level (mean difference = 4.03, 95% CI [0.90, 7.15], p =.01). A categorical improvement of “much/very much improved” (CGI-SF score = 2) was reported by 58.3% (n = 21/36) of bupropion SR-assigned versus 27.7% (n = 10/36) placebo-assigned patient. Bupropion was well tolerated with no serious adverse events reported other than insomnia (17.7%). Six weeks of bupropion SR treatment reported significant improvement in key aspects of sexual function among male opiate-dependent patients on methadone maintenance treatment with emergent sexual dysfunction. SAGE Publications 2018 Article PeerReviewed Yee, Anne and Loh, Huai Seng and Ong, Teng Aik and Ng, Chong Guan and Sulaiman, Ahmad Hatim (2018) Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial of Bupropion as Treatment for Methadone-Emergent Sexual Dysfunction in Men. American Journal of Men's Health, 12 (5). pp. 1705-1718. ISSN 1557-9883, DOI https://doi.org/10.1177/1557988318784152 <https://doi.org/10.1177/1557988318784152>. https://doi.org/10.1177/1557988318784152 doi:10.1177/1557988318784152 |
| spellingShingle | R Medicine Yee, Anne Loh, Huai Seng Ong, Teng Aik Ng, Chong Guan Sulaiman, Ahmad Hatim Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial of Bupropion as Treatment for Methadone-Emergent Sexual Dysfunction in Men |
| title | Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial of Bupropion as Treatment for Methadone-Emergent Sexual Dysfunction in Men |
| title_full | Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial of Bupropion as Treatment for Methadone-Emergent Sexual Dysfunction in Men |
| title_fullStr | Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial of Bupropion as Treatment for Methadone-Emergent Sexual Dysfunction in Men |
| title_full_unstemmed | Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial of Bupropion as Treatment for Methadone-Emergent Sexual Dysfunction in Men |
| title_short | Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial of Bupropion as Treatment for Methadone-Emergent Sexual Dysfunction in Men |
| title_sort | randomized double blind parallel group placebo controlled trial of bupropion as treatment for methadone emergent sexual dysfunction in men |
| topic | R Medicine |
| work_keys_str_mv | AT yeeanne randomizeddoubleblindparallelgroupplacebocontrolledtrialofbupropionastreatmentformethadoneemergentsexualdysfunctioninmen AT lohhuaiseng randomizeddoubleblindparallelgroupplacebocontrolledtrialofbupropionastreatmentformethadoneemergentsexualdysfunctioninmen AT ongtengaik randomizeddoubleblindparallelgroupplacebocontrolledtrialofbupropionastreatmentformethadoneemergentsexualdysfunctioninmen AT ngchongguan randomizeddoubleblindparallelgroupplacebocontrolledtrialofbupropionastreatmentformethadoneemergentsexualdysfunctioninmen AT sulaimanahmadhatim randomizeddoubleblindparallelgroupplacebocontrolledtrialofbupropionastreatmentformethadoneemergentsexualdysfunctioninmen |