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临床试验/ACTRN12622000245796
ACTRN12622000245796尚未招募2 期

Active-controlled trial of a Ketamine Assisted Group Mindfulness intervention for Alcohol Use Disorder

niversity of Otago0 个研究点目标入组 80 人开始时间: 2022年2月10日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
入组人数
80

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 70 Years(—)
性别
All

入选标准

  • Capable of understanding and signing an informed consent
  • Aged 18 years and over, and under 70 years old on the day of consent
  • Have an established diagnosis of moderate to severe AUD

排除标准

  • Female participants who are or intend to become pregnant or are lactating.
  • 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.
  • Any participant for whom the investigator believes, for any reason, that participation would not be an acceptable risk.
  • Participants who are starting new antidepressants, anxiolytics or psychotherapy within four weeks of enrolment. Use of antidepressants, anxiolytics at stable doses > four weeks prior or psychotherapy is acceptable.
  • Active suicidal ideation as operationalise by a CSSR score of four or higher.
  • Participants with comorbid schizophrenia or bipolar disorder. Depression and anxiety is acceptable.
  • Participants with current other moderate to severe substance use disorder other than nicotine or caffeine.
  • Participants with severe personality disorders as judged elevated risk by the investigator.
  • Participants who are on parole.

研究者

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