Trial protocol of an open-label pilot study of oral naltrexone–bupropion combination pharmacotherapy for the treatment of methamphetamine use disorder (the NABU trial)
Introduction Methamphetamine use disorder is a global public health concern with no approved pharmacotherapies for its treatment. One recent randomised controlled trial conducted in the USA examined a combination of bupropion and naltrexone not readily available globally. Here, we report a trial pro...
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BMJ Publishing Group
2025-02-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/2/e092032.full |
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| author | Jonathan Brett Paul S Haber Nicholas Lintzeris Didier Jutras-Aswad Nadine Ezard Brendan Clifford Krista J Siefried Adrian John Dunlop Liam Acheson Carl Moller Michael Christmass Kirsten Morley Steven Shoptaw Madhukar H Trivedi |
| author_facet | Jonathan Brett Paul S Haber Nicholas Lintzeris Didier Jutras-Aswad Nadine Ezard Brendan Clifford Krista J Siefried Adrian John Dunlop Liam Acheson Carl Moller Michael Christmass Kirsten Morley Steven Shoptaw Madhukar H Trivedi |
| author_sort | Jonathan Brett |
| collection | DOAJ |
| description | Introduction Methamphetamine use disorder is a global public health concern with no approved pharmacotherapies for its treatment. One recent randomised controlled trial conducted in the USA examined a combination of bupropion and naltrexone not readily available globally. Here, we report a trial protocol for an oral formulation of combined naltrexone and bupropion.Methods and analysis This single-arm, open-label pilot study will assess the safety and feasibility of oral naltrexone and bupropion (40 mg/450 mg daily in divided doses) in adults with methamphetamine use disorder. Participants (n=20) will be outpatients of a stimulant treatment program at an inner-city hospital in Sydney, Australia. The primary endpoint is Day 84. Participants will attend weekly study visits from Baseline to Week 12 and a follow-up telephone visit at Week 16. All participants will receive treatment as usual, such as psychosocial therapy. Primary outcomes are safety (measured by treatment-emergent adverse events (AEs)/adverse reactions) and feasibility (measured by the time taken to recruit, the proportion of ineligible participants, retention in the study and study medication adherence). Secondary outcomes will assess methamphetamine use, craving and withdrawal; treatment goals and expectations; physical and psychological well-being; depression and anxiety; and treatment satisfaction. Qualitative interviews will assess the acceptability of the intervention and outcome measures.Ethics and dissemination This study received ethics approval from the St Vincent’s Hospital Human Research Ethics Committee (2023/ETH00549). Results will be submitted to peer-reviewed journals and scientific conferences, and a video abstract will be created to ensure that the findings are accessible to participants and people who use methamphetamines.Trial registration number ANZCTR: ACTRN12623000866606 (protocol V.2.1 dated 08 April 2024). |
| format | Article |
| id | doaj-art-83e831326128412ea0ebf9a747b44d2d |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-83e831326128412ea0ebf9a747b44d2d2025-02-08T08:40:12ZengBMJ Publishing GroupBMJ Open2044-60552025-02-0115210.1136/bmjopen-2024-092032Trial protocol of an open-label pilot study of oral naltrexone–bupropion combination pharmacotherapy for the treatment of methamphetamine use disorder (the NABU trial)Jonathan Brett0Paul S Haber1Nicholas Lintzeris2Didier Jutras-Aswad3Nadine Ezard4Brendan Clifford5Krista J Siefried6Adrian John Dunlop7Liam Acheson8Carl Moller9Michael Christmass10Kirsten Morley11Steven Shoptaw12Madhukar H Trivedi136 St Vincent`s Clinical School, The University of New South Wales, Sydney, New South Wales, Australia4 New South Wales Drug and Alcohol Clinical Research and Improvement Network (DACRIN), c/o The Ministry of Health New South Wales, St Leonards, New South Wales, Australia4 New South Wales Drug and Alcohol Clinical Research and Improvement Network (DACRIN), c/o The Ministry of Health New South Wales, St Leonards, New South Wales, Australia12 Research Centre, Centre Hospitalier de l`Université de Montréal (CRCHUM), Montreal, Quebec, Canada1 The National Centre for Clinical Research on Emerging Drugs (NCCRED), The University of New South Wales, Sydney, New South Wales, Australia1 The National Centre for Clinical Research on Emerging Drugs (NCCRED), The University of New South Wales, Sydney, New South Wales, Australia1 The National Centre for Clinical Research on Emerging Drugs (NCCRED), The University of New South Wales, Sydney, New South Wales, Australia4 New South Wales Drug and Alcohol Clinical Research and Improvement Network (DACRIN), c/o The Ministry of Health New South Wales, St Leonards, New South Wales, Australia1 The National Centre for Clinical Research on Emerging Drugs (NCCRED), The University of New South Wales, Sydney, New South Wales, Australia1 The National Centre for Clinical Research on Emerging Drugs (NCCRED), The University of New South Wales, Sydney, New South Wales, Australia7 Next Step Drug and Alcohol Services, East Metropolitan Health Service, Perth, Western Australia, Australia10 Faculty of Medicine and Health, Central Clinical School, Discipline of Addiction Medicine, University of Sydney, Sydney, New South Wales, Australia15 Department of Family Medicine, University of California Los Angeles, Los Angeles, California, USA16 Peter O`Donnell Jr. Brain Institute, The University of Texas Southwestern Medical Center, Dallas, Texas, USAIntroduction Methamphetamine use disorder is a global public health concern with no approved pharmacotherapies for its treatment. One recent randomised controlled trial conducted in the USA examined a combination of bupropion and naltrexone not readily available globally. Here, we report a trial protocol for an oral formulation of combined naltrexone and bupropion.Methods and analysis This single-arm, open-label pilot study will assess the safety and feasibility of oral naltrexone and bupropion (40 mg/450 mg daily in divided doses) in adults with methamphetamine use disorder. Participants (n=20) will be outpatients of a stimulant treatment program at an inner-city hospital in Sydney, Australia. The primary endpoint is Day 84. Participants will attend weekly study visits from Baseline to Week 12 and a follow-up telephone visit at Week 16. All participants will receive treatment as usual, such as psychosocial therapy. Primary outcomes are safety (measured by treatment-emergent adverse events (AEs)/adverse reactions) and feasibility (measured by the time taken to recruit, the proportion of ineligible participants, retention in the study and study medication adherence). Secondary outcomes will assess methamphetamine use, craving and withdrawal; treatment goals and expectations; physical and psychological well-being; depression and anxiety; and treatment satisfaction. Qualitative interviews will assess the acceptability of the intervention and outcome measures.Ethics and dissemination This study received ethics approval from the St Vincent’s Hospital Human Research Ethics Committee (2023/ETH00549). Results will be submitted to peer-reviewed journals and scientific conferences, and a video abstract will be created to ensure that the findings are accessible to participants and people who use methamphetamines.Trial registration number ANZCTR: ACTRN12623000866606 (protocol V.2.1 dated 08 April 2024).https://bmjopen.bmj.com/content/15/2/e092032.full |
| spellingShingle | Jonathan Brett Paul S Haber Nicholas Lintzeris Didier Jutras-Aswad Nadine Ezard Brendan Clifford Krista J Siefried Adrian John Dunlop Liam Acheson Carl Moller Michael Christmass Kirsten Morley Steven Shoptaw Madhukar H Trivedi Trial protocol of an open-label pilot study of oral naltrexone–bupropion combination pharmacotherapy for the treatment of methamphetamine use disorder (the NABU trial) BMJ Open |
| title | Trial protocol of an open-label pilot study of oral naltrexone–bupropion combination pharmacotherapy for the treatment of methamphetamine use disorder (the NABU trial) |
| title_full | Trial protocol of an open-label pilot study of oral naltrexone–bupropion combination pharmacotherapy for the treatment of methamphetamine use disorder (the NABU trial) |
| title_fullStr | Trial protocol of an open-label pilot study of oral naltrexone–bupropion combination pharmacotherapy for the treatment of methamphetamine use disorder (the NABU trial) |
| title_full_unstemmed | Trial protocol of an open-label pilot study of oral naltrexone–bupropion combination pharmacotherapy for the treatment of methamphetamine use disorder (the NABU trial) |
| title_short | Trial protocol of an open-label pilot study of oral naltrexone–bupropion combination pharmacotherapy for the treatment of methamphetamine use disorder (the NABU trial) |
| title_sort | trial protocol of an open label pilot study of oral naltrexone bupropion combination pharmacotherapy for the treatment of methamphetamine use disorder the nabu trial |
| url | https://bmjopen.bmj.com/content/15/2/e092032.full |
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