The Effects of Medical Cannabis in Children With Autistic Spectrum Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Cannabinoids levels change
研究概览
简要总结
Children with autism spectrum disorder (ASD) commonly exhibit comorbid symptoms such as aggression, hyperactivity and anxiety. Data on the effects of cannabidiol rich cannabis extract use for ASD is promising but still limited. The aim of this study is to investigate if oral cannabinoids treatment to children and young adults with ASD affect the comorbidities of autism, including sleep and eating problems, anxiety and violence.
The main objectives of the study are: 1) to characterize the effect of treatment with cannabis oil on comorbid symptoms of ASD; 2) to compare safety and efficacy of different cannabis products with identical CBD:THC ratio; 3) to investigate the effect of treatment on cognitive and adaptive behavior; and 4) to measure THC and CBD and metabolites levels in the blood of the patients.
In this study, patients diagnosed with ASD will be treated with cannabidiol-rich cannabis oil (CBD:THC ratio of 20:1). The researchers will collect parental reports on ASD comorbid symptoms before and bi-weekly during 6 months of the study period. Blood tests will be performed before and after three months of treatment. Blood tests include blood count, blood chemistry, hormones profile, phyto- and endo- cannabinoids and metabolites. Cognitive evaluation will be done before and after six months of treatment. Electroencephalogram (EEG) to exclude epilepsy will be performed before and after six months of treatment.
详细描述
Participants will be screened by the PI, a specialist neurologist. For those passing screening, license for Cannabis will be obtained at MOH.
Participants will pass tests such as ADOS (communication skills) and Wechsler (IQ), parents will fill questionnaires.
Treatment will start in a titration mode till improvement in some parameters is seen or till treatment failure decision is made.
Participants will be called for a check-up by mid-time (after 3 months) and their parents will fill questionnaires.
Participants will be called for a last check-up after 6 months from treatment beginning and pass again ADOS and Wechsler tests. Parents will fill questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Epilepsy with clinical symptoms
- •Current or previous treatment with cannabis
- •Genetic disorder that can cause ASD symptoms
- •Metabolic disorder
- •immunologic disorder
- •liver cancer
- •Participants who, in the researcher's opinion, will not cooperate in the various research procedures
- •Women which are pregnant or breastfeeding.
- •Psychosis or schizophrenia or past or present schizoaffective disorder, in first-degree relatives
- •History of substance abuse or abuse (including cannabis use disorder or alcohol addiction) in first-degree relatives
- •Hypersensitivity to coconut oil / palm oil
研究组 & 干预措施
Seach CBD:THC 20:1 cannabis oil
cannabis oil containing CBD:THC ratio of 20:1. plant material is grown by Seach LTD and oil manufactured by Nextar Pharma LTD.
干预措施: Cannabis oil (Drug)
Candoc CBD:THC 20:1 cannabis oil
cannabis oil containing CBD:THC ratio of 20:1. plant material is grown by Candoc LTD and oil manufactured by Panaxia LTD.
干预措施: Cannabis oil (Drug)
结局指标
主要结局
Cannabinoids levels change
时间窗: 3 months
To compare CBD, THC their and metabolites blood levels before and after intervention
Changes in attention span
时间窗: 6 months
To characterize the effect of medical cannabis treatment on the attention span using Conners teacher questionnaires. Significant change is defined as a change of 10% in questionnaire score between baseline and 6 months.
Changes in cognitive level
时间窗: 6 months
To examine the effect of cannabis treatment on cognitive level using part of Wechsler test. Significant change is defined as a change of 10% in questionnaire score between baseline and 6 months.
Comparison of efficacy between two different cannabis oil products
时间窗: 6 months
To compare efficacy of medical cannabis products with the same CBD: THC ratio in terms of communication skills using ADOS test. Significant change is defined as a change of 10% in raw questionnaire score between baseline and 6 months.
Changes in violent behavior
时间窗: 6 months
To examine the effect of cannabis treatment on violent behavior as per specific trial-designed questionnaire. Significant change is defined as a change of 10% in questionnaire score between baseline and 6 months.
Changes in adaptive behavior
时间窗: 6 months
To examine the effect of cannabis treatment on adaptive behavior as per ADOS test. Significant change is defined as a change of 10% in raw questionnaire score between baseline and 6 months.
次要结局
- Therapeutic failure(6 months)
- Changes in hormonal profile(3 months)
- Changes in sleep problems(6 months)
- Side effects(6 months)
- Changes in eating problems(6 months)
- Changes in biochemical parameters(3 months)