Siefried Krista J, Acheson Liam, Clifford Brendan, Moller Carl, Brett Jonathan, Christmass Michael, Dunlop Adrian John, Haber Paul S, Jutras-Aswad Didier, Lintzeris Nicholas, Morley Kirsten, Shoptaw Steven, Trivedi Madhukar H, Ezard Nadine
The National Centre for Clinical Research on Emerging Drugs (NCCRED), The University of New South Wales, Sydney, New South Wales, Australia
Alcohol and Drug Service, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.
BMJ Open. 2025 Feb 7;15(2):e092032. doi: 10.1136/bmjopen-2024-092032.
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.
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.
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.
ANZCTR: ACTRN12623000866606 (protocol V.2.1 dated 08 April 2024).
甲基苯丙胺使用障碍是一个全球公共卫生问题，目前尚无获批用于治疗该疾病的药物疗法。美国最近进行的一项随机对照试验研究了安非他酮和纳曲酮的组合，而这种组合在全球范围内并不容易获得。在此，我们报告一项关于纳曲酮和安非他酮联合口服制剂的试验方案。
这项单臂、开放标签的试点研究将评估口服纳曲酮和安非他酮（每日40毫克/450毫克，分剂量服用）对患有甲基苯丙胺使用障碍的成年人的安全性和可行性。参与者（n = 20）将是澳大利亚悉尼一家市中心医院兴奋剂治疗项目的门诊患者。主要终点为第84天。参与者将从基线期到第12周每周参加一次研究访视，并在第16周进行一次随访电话访视。所有参与者将接受常规治疗，如心理社会治疗。主要结局指标为安全性（通过治疗中出现的不良事件/不良反应来衡量）和可行性（通过招募所需时间、不符合资格的参与者比例、研究中的留存率和研究药物依从性来衡量）。次要结局指标将评估甲基苯丙胺的使用情况、渴望程度和戒断反应；治疗目标和期望；身心健康状况；抑郁和焦虑；以及治疗满意度。定性访谈将评估干预措施和结局指标的可接受性。
本研究获得了圣文森特医院人类研究伦理委员会的伦理批准（2023/ETH00549）。研究结果将提交给同行评审期刊和科学会议，并制作视频摘要，以确保研究结果可供参与者和使用甲基苯丙胺的人获取。
澳大利亚新西兰临床试验注册中心：ACTRN12623000866606（2024年4月8日版本V.2.1协议）
