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临床试验/EUCTR2021-004981-37-NO
EUCTR2021-004981-37-NO进行中(未招募)1 期

Benzodiazepine maintenance treatment for patients with benzodiazepine dependence undergoing opioid agonist therapy (BMX-BAR)

Helse Bergen HF0 个研究点目标入组 90 人开始时间: 2021年10月11日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
90

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Adult age (= 18 years)
  • Opioid dependence according to ICD-10, and ongoing OAT
  • Benzodiazepine dependence according to ICD-10 under the following conditions:
  • -Minimum duration is the last 5 years
  • -Use 5-7 days a week during the last month
  • -Minimum dose used is equivalent to 15 mg diazepam/d or higher
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 90
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Severe respiratory failure (GOLD 3-4)
  • High risk of violent behavior (current violence episodes)
  • High risk of substance related overdose (current overdoses)
  • Severe cognitive impairment (IQ<70)
  • Severe psychosis (current psychotic symptoms and functioning)
  • Severe depression and high suicide risk (current episodes)
  • Patients who are already being prescribed continuous benzodiazepines
  • Pregnancy and breastfeeding

研究者

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