ACTRN12624001061527尚未招募4 期
Efficacy of Oral Lisdexamfetamine for the treatment of Acute Methamphetamine withdrawal symptoms (the OLAM trial): A randomised controlled trial
St Vincent's Hospital Sydney0 个研究点目标入组 184 人开始时间: 2024年9月3日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 184
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Aged 18 years and older
- •Presenting to drug treatment service seeking methamphetamine withdrawal treatment
- •Determined by an Addiction Medicine Specialist or Psychiatrist to have methamphetamine use disorder (DSM-5-TR criteria)
- •Reporting last use of methamphetamine within 72 hours of first dose of study drug
- •Point-of-care urine drug test positive for methamphetamine
- •Willing and able to provide written, informed consent
排除标准
- •Concurrent dependence on non-prescribed opioids or benzodiazepines, or alcohol or gamma-hydroxybutyrate (GHB) (based on DSM-5TR criteria)
- •Lactating, pregnant or of childbearing potential and not willing to avoid becoming pregnant during the study
- •Contraindications to lisdexamfetamine (per product label) other than drug dependence:
- •Acute severe mental/physical comorbidity that would interfere with study participation, as assessed by the site PI
- •Currently experiencing psychosis or suicidality
- •Exposure to lisdexamfetamine, dexamphetamine, modafinil or methylphenidate in the 4 weeks prior to screening
研究者
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