EUCTR2013-000361-36-GB进行中（未招募）1 期
A phase IIa/b, randomised, double-blind, placebo-controlled, single-site, parallel group clinical trial to examine cannabidiol (CBD) as a pharmacological treatment for cannabis dependence in a young cannabis dependent population. - Cannabidiol: a novel intervention for cannabis use problems?
Joint Research Office0 个研究点目标入组 82 人开始时间: 2013年8月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 82
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
- •1.Age: between 16 and 26 years old 2.Gender: all 3.All will meet DSM-5 criteria for moderate cannabis use disorder (=4 DSM-5 criteria). DSM refers to the Diagnostic and Statistical Manual for Mental Disorders, widely used to diagnose mental illness in psychiatry. Please note that the diagnostic criteria of 'cannabis dependence' in the previous edition (DSM-4) was replaced with 'cannabis use disorder' (DSM-5) in May 2013. 4.Express a desire to quit using cannabis within the next four weeks and report =1 previous failed quit attempt 5.Smoke tobacco with cannabis 6.Provide a urine sample positive for cannabis (qualitative urine screen) 7.Vital signs within healthy limits (blood pressure, heart rate, respiratory peak flow) 8.Capacity to give informed consent as defined by GCP guidelines 9.Females of childbearing potential and males must be willing to use an effective method of contraception including oral, injected or implanted hormonal methods of contraception; placement of an IUS (intrauterine system) or IUD (intrauterine device); barrier method of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository; male sterilization); true abstinence of birth control; abstinence from the time consent is signed until 6 weeks after treatment discontinuation 10.Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for trial treatment.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 138
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Females who are pregnant or breastfeeding 2.Allergies to IMP or placebo and its excipients 3.>twice/month use of other illicit drugs 4.Current prescribed psychotropic use 5.Outside normal Body Mass Index (<16 or >30) 6.Any physical health problem as deemed clinically significant by the investigator team 7.Non English speakers (because of verbal test assessments)
研究者
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