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临床试验/ACTRN12620000880943
ACTRN12620000880943尚未招募1 期

Methylphenidate sustained release in methamphetamine use disorder – a pilot, open label, safety study

Christopher Gale0 个研究点目标入组 10 人开始时间: 2020年9月4日最近更新:
适应症

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
10

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
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 65 Years(—)
性别
All

入选标准

  • (1)able to provide written informed consent;
  • (2)aged 18-65 years on the day of consent;
  • (3)Body Mass Index 17-35 kg/m2 at screening;
  • (4)meet DSM-5 criteria for methamphetamine use disorder as diagnosed using the PRISM (http://www.columbia.edu/~dsh2/prism/);
  • (5)Have a urine drug screen on day one that does not contain opiates, benzodiazepines, cannabinoids or stimulants.

排除标准

  • 1.History of psychotic episodes, or evidence current or past psychosis on the PRISM
  • 2.evidence from medical history of current significant or unstable cardiac or other medical conditions;
  • 3.history of epilepsy, head trauma, or central nervous system diseases;
  • 4.female patients who are pregnant or lactating;
  • 5.participants who, in the opinion of the investigator, do not understand the information and procedures of the study, or would not be compliant with them.
  • 6.Q-Tc of over 450 ms on 12 lead ECG
  • 7.Premorbid ST changes consistent with previous ischaemia in 12 lead ECG.
  • 8.A drug screen on any day that has more than methyphenidate in it.

研究者

发起方
Christopher Gale

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