Muhamad Nor Asiah, Ma'amor Nur Hasnah, Muhamad Rasat Muhammad Arif, Tengku Baharudin Shah Tengku Puteri Nadiah, Rosli 'Izzah 'Athirah, Leman Fatin Norhasny, Jamalluddin Nurul Hidayah, Misnan Nurul Syazwani, Chemi Norliza, Abdullah Norni, Ibrahim Nurashikin
Sector for Evidence-based Healthcare, National Institutes of Health, Ministry of Health, Selangor, Malaysia.
Department of Psychiatry and Mental Health, Sultanah Bahiyyah Hospital, Ministry of Health, Kedah, Malaysia.
JMIR Res Protoc. 2025 Aug 7;14:e64101. doi: 10.2196/64101.
Naltrexone is an opioid receptor antagonist. Naltrexone is used to block the euphoric and sedative effects of drugs such as heroin, codeine, and morphine. The medication helps to bind and block opioid receptors to decrease opioid cravings. In Malaysia, naltrexone has been used for maintenance treatments for heroin and alcohol since 1996. However, since 2011, naltrexone has been used as an off-label stimulant use disorder (StUD) treatment to achieve abstinence.
This study aims to determine the abstinence among StUD and non-StUD patients treated and without naltrexone.
We will conduct a retrospective cohort study on the effect of naltrexone or treatment as usual (TAU) by examining the data for both StUD and non-StUD patients. We will use patients' clinical records from the hospital registry. All adult patients (aged 18-65 years) diagnosed with StUD or other substance use disorders who were treated with naltrexone and standard care from January 1, 2011, to December 31, 2023, will be screened. All StUD and non-StUD patients who were offered the naltrexone treatment or TAU at the beginning of treatment will be recruited. All data will be extracted using a standardized data extraction form. Descriptive analysis will be performed to describe the distribution of patient characteristics, sociodemographic profiles, and percentages of abstinence and treatment retention. We will conduct univariable analysis to determine the association of stimulant abstinence and treatment retention between naltrexone and TAU among both StUD and non-StUD patients. All significant independent variables will be further analyzed using a cross-sectional time series method for categorical variables.
Recruitment began in July 2025. Data analysis will begin after completing data collection, planned for January 2026.
The expected main outcome of this study is to observe the significant associations of stimulant use abstinence and treatment retention between TAU and naltrexone among StUD and non-StUD patients. The findings from this study may provide preliminary evidence regarding the use of naltrexone in treating StUD. Currently, there is no specific medication to treat amphetamine or methamphetamine use disorder. The effect of naltrexone with psychosocial interventions for StUD is unclear. Public health approaches recognize the multifaceted nature of substance misuse and focus on addressing the myriad individual, environmental, and social factors that contribute to StUD.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/64101.
纳曲酮是一种阿片受体拮抗剂。纳曲酮用于阻断海洛因、可待因和吗啡等药物产生的欣快感和镇静作用。该药物有助于结合并阻断阿片受体，以减少对阿片类药物的渴望。在马来西亚，自1996年以来，纳曲酮一直用于海洛因和酒精的维持治疗。然而，自2011年以来，纳曲酮已被用作一种非标签的兴奋剂使用障碍（StUD）治疗药物，以实现戒断。
本研究旨在确定接受和未接受纳曲酮治疗的StUD患者和非StUD患者的戒断情况。
我们将通过检查StUD患者和非StUD患者的数据，对纳曲酮或常规治疗（TAU）的效果进行一项回顾性队列研究。我们将使用医院登记处的患者临床记录。将筛选出2011年1月1日至2023年12月31日期间接受纳曲酮和标准护理治疗的所有成年患者（年龄18 - 65岁），这些患者被诊断患有StUD或其他物质使用障碍。所有在治疗开始时接受纳曲酮治疗或TAU的StUD患者和非StUD患者都将被招募。所有数据将使用标准化数据提取表进行提取。将进行描述性分析，以描述患者特征、社会人口统计学概况以及戒断和治疗保留率的分布情况。我们将进行单变量分析，以确定StUD患者和非StUD患者中纳曲酮与TAU之间兴奋剂戒断和治疗保留的关联。所有显著的独立变量将使用横断面时间序列方法对分类变量进行进一步分析。
招募工作于2025年7月开始。计划于2026年1月完成数据收集后开始数据分析。
本研究的预期主要结果是观察StUD患者和非StUD患者中TAU与纳曲酮之间兴奋剂使用戒断和治疗保留的显著关联。本研究的结果可能为纳曲酮用于治疗StUD提供初步证据。目前，尚无治疗苯丙胺或甲基苯丙胺使用障碍的特定药物。纳曲酮与心理社会干预措施对StUD的效果尚不清楚。公共卫生方法认识到药物滥用的多面性，并专注于解决导致StUD的众多个人、环境和社会因素。
国际注册报告识别码（IRRID）：PRR1 - 10.2196/64101。
