ACTRN12616000516482终止1 期
Phase I/II, dose ranging study of the pharmacokinetics dose-response parameters, and feasibility of vaporised botanical cannabis flower bud in advanced cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 13
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
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1) Age 18 years or above;
- •2) Advanced cancer;
- •3) Anorexia for at least 2 weeks (defined as numeric rating scale [0 no appetite – 10 best possible appetite] score less than or equal to 4) unresponsive to the optimisation of treatment of causative medical conditions
- •4) English-speaking (or have an interpreter available);
- •5) Performance status (Australia-modified Karnofsky Scale score) of 40 or above;
- •6) Written informed consent.
排除标准
- •1) Hepatic impairment (Child’s Stage B)
- •2) Renal impairment (estimated glomerular filtration rate of <10 mL/min)
- •3) Cognitive impairment (Montreal Cognitive Assessment (MOCA score<26);
- •4) Psychiatric disorders (severe depression or anxiety, personality disorder, history of psychosis, schizophrenia, and/or suicidal ideation);
- •5) Acute delirium or delirium within < 30 days;
- •6) Unstable cardiovascular disease (uncontrolled hypertension, unstable ischaemic heart disease, unstable congestive cardiac failure);
- •7) Impaired pulmonary function which prohibits use of vaporiser;
- •8) Prior adverse reaction to botanical cannabis/pharmaceuticals containing cannabinoids;
- •9) Pregnant, breastfeeding or unwillingness to use oral contraceptives;
- •10) Substance use disorder (ICD-10 criteria (abuse, dependence)) to alcohol, opioids, benzodiazepines or simulants (excluding caffeine, tobacco).
- •11) Recent use of cannabis or cannabinoids within < 30 days (based on self-report and urine drug screen at eligibility).
- •12) Prescribed opioid, benzodiazepine, antidepressant, antipsychotic, corticosteroid, progestin, omega fatty acids and/or dietary supplements, which do not meet the criteria for therapies allowed at eligibility assessment
- •13) Participation in a clinical trial of another chemical entity.
- •14) Conditions causing irreversible or blood transfusion dependent anaemia where the volume of blood sampling required for this study is contraindicated in the opinion of the treating clinician.
研究者
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