The National Drug and Alcohol Research Centre (NDARC), the University of New South Wales, Sydney, Australia.
Alcohol and Drug Service, St Vincent's Hospital Sydney, Sydney, Australia.
PLoS One. 2022 Oct 3;17(10):e0275371. doi: 10.1371/journal.pone.0275371. eCollection 2022.
Methamphetamine (MA) use disorder is an important public health concern. MA withdrawal is often the first step in ceasing or reducing use. There are no evidence-based withdrawal treatments, and no medication is approved for the treatment of MA withdrawal. Lisdexamfetamine (LDX) dimesilate, used in the treatment of attention deficit hyperactivity disorder and binge eating disorder has the potential as an agonist therapy to ameliorate withdrawal symptoms, and improve outcomes for patients.
A single arm, open-label pilot study to test the safety and feasibility of LDX for the treatment of MA withdrawal. Participants will be inpatients in a drug and alcohol withdrawal unit, and will receive a tapering dose of LDX over five days: 250mg LDX on Day 1, reducing by 50mg per day to 50mg on Day 5. Optional inpatient Days 6 and 7 will allow for participants to transition to ongoing treatment. Participants will be followed-up on Days 14, 21 and 28. All participants will also receive standard inpatient withdrawal care. The primary outcomes are safety (measured by adverse events, changes in vital signs, changes in suicidality and psychosis) and feasibility (the time taken to enrol the sample, proportion of screen / pre-screen failures). Secondary outcomes are acceptability (treatment satisfaction questionnaire, medication adherence, concomitant medications, qualitative interviews), retention to protocol (proportion retained to primary and secondary endpoints), changes in withdrawal symptoms (Amphetamine Withdrawal Questionnaire) and craving for MA (visual analogue scale), and sleep outcomes (continuous actigraphy and daily sleep diary).
This is the first study to assess lisdexamfetamine for the treatment of acute MA withdrawal. If safe and feasible results will go to informing the development of multi-centre randomised controlled trials to determine the efficacy of the intervention.
甲基苯丙胺（MA）使用障碍是一个重要的公共卫生问题。MA 戒断通常是停止或减少使用的第一步。目前没有基于证据的戒断治疗方法，也没有药物被批准用于治疗 MA 戒断。Lisdexamfetamine（LDX）二甲硫酸盐，用于治疗注意缺陷多动障碍和暴食障碍，具有作为一种激动剂疗法改善戒断症状的潜力，并改善患者的治疗效果。
一项单臂、开放性先导研究，旨在测试 LDX 治疗 MA 戒断的安全性和可行性。参与者将是药物和酒精戒断病房的住院患者，将接受 LDX 的逐渐减量治疗：第 1 天 250mg LDX，每天减少 50mg，第 5 天减少至 50mg。可选的第 6 和第 7 天住院日允许参与者过渡到持续治疗。参与者将在第 14、21 和 28 天进行随访。所有参与者还将接受标准的住院戒断护理。主要结局是安全性（通过不良事件、生命体征变化、自杀意念和精神病变化来衡量）和可行性（招募样本所需的时间、筛查/预筛查失败的比例）。次要结局是可接受性（治疗满意度问卷、药物依从性、伴随药物、定性访谈）、对方案的保留（保留到主要和次要终点的比例）、戒断症状的变化（安非他明戒断问卷）和对 MA 的渴望（视觉模拟量表），以及睡眠结果（连续活动记录仪和每日睡眠日记）。
这是第一项评估 lisdexamfetamine 治疗急性 MA 戒断的研究。如果结果安全且可行，将进一步开展多中心随机对照试验，以确定该干预措施的疗效。
