ACTRN12620000847910尚未招募1 期
Safety and Effect of Medical Cannabis on Relapse among 20 Patients with Methamphetamine Use Disorder: A Proof-of-Concept Trial
Medical Cannabis Research Australia (Limited)0 个研究点目标入组 40 人开始时间: 2020年8月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
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 60 Years（—）
- 性别
- All
入选标准
- •Aged between 18 and 60 years (inclusive);
- •- Ability to give informed consent;
- •- Have met DSM-5 criteria for methamphetamine use disorder in the past 12 months;
- •- Abstinent from methamphetamine for 5-14 days prior to enrolment;
- •- Agree to a referral to an outpatient clinic for psychological services;
- •- Previous use of cannabis; and,
- •- Willing and able to follow study instructions and likely to complete all study requirements.
排除标准
- •- History of diagnosed psychotic disorder;
- •- Family history of a diagnosed psychotic disorder or Type I bipolar disorder;
- •- Admission to an inpatient mental health service for more than one week in the past 12 months;
- •- Current cannabis use;
- •- Pregnancy, lactation, or if sexually active is not on effective contraception;
- •- Prior sensitivity or allergy to CBD or any cannabis-derived product;
- •- Currently being treated with any medication that contraindicates with CBD, or which in the doctor’s opinion puts the participant at significant risk, could confound the study results, or may interfere significantly with the person’s participation in the study;
- •- Participation in any investigational drug study within 30 days prior to screening;
- •- Clinically significant (as judged by the participant’s doctor at alcohol and other drug service) presence of acute illness (e.g. gastrointestinal illness, infection such as influenza, upper respiratory tract infection) at admission to the service;
- •- Abnormal liver or thyroid function, or haematological findings (>15% above or below normal range);
- •- Acute or unstable systemic medical disorder;
- •- History of brady- or tachy-dysrhythmias;
- •- History of heart failure or heart disease;
- •- Positive screen for hepatitis B surface antigen, Hepatitis C Virus and Human Immunodeficiency Virus;
- •- Any condition, which in the doctor’s opinion, puts the participant at significant risk, could confound the study results or may interfere significantly with the participant’s participation in the study;
- •- Received oral pharmacotherapy for methamphetamine relapse prevention in the past 14 days;
- •- Received naltrexone implant pharmacotherapy in the past 6 months; or,
- •- Anticipated need for surgery or hospitalisation during the study.
研究者
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