Cannabinoids for Behavioral Problems in Autism Spectrum Disorder: A Double Blind, Randomized, Placebo-controlled Trial With Crossover.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change from baseline Home Situations Questionnaire-Autism Spectrum Disorder (HSQ-ASD) score, at three months. Within subject difference between the placebo condition and the whole plant extract condition.
研究概览
简要总结
This study aims to assess the safety, tolerability and efficacy of cannabinoids mix [cannabidiol (CBD), Δ9-tetrahydrocannabinol (THC) in a 20:1 ratio, BOL Pharma, Israel] for behavioral problems in children and youth with ASD.
详细描述
Disruptive behaviors are very common in children and youth with autism spectrum disorder (ASD). Behavioral problems increase social impairment in children with ASD, make interventions more difficult and place considerable strain on families and caregivers. Current treatment is based on behavioral interventions combined with atypical antipsychotics which often have low tolerability and questionable efficacy.
Cannabis exerts profound effects on human social behavior. Research using animal models of ASD indicate a possible dysregulation of the endocannabinoid system, and stress that it may be a novel target for pharmacological interventions. Anecdotal evidence suggest efficacy of various phytocannabinoids in resistant behavioral problems. However controlled human studies are lacking.
Objective: To assess the safety, tolerability and efficacy of cannabinoids mix [cannabidiol (CBD), Δ9-tetrahydrocannabinol (THC) in a 20:1 ratio, BOL Pharma, Israel] for behavioral problems in children and youth with ASD.
Setting: A double blind randomized placebo-controlled trial with crossover.
Methods: One hundred and fifty participants, ages 5-21 years, with ASD and moderate to severe refractory behavioral problems will be randomized to receive 1 out of 3 treatments for 12-weeks and cross-over to another treatment in a second 12 weeks period. Treatment options are: (1) oral placebo (2) cannabis extract, contains cannabidiol and Δ9-tetrahydrocannabinol in a 20:1 ratio, at a cannabidiol dose of 10 mg/kg/d and (3) pure cannabidiol and Δ9-tetrahydrocannabinol in the same ratio and dose.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(both are needed)
- •ASD diagnosis (Diagnostic and Statistical Manual of Mental Disorders [Fifth Edition; DSM-V]
- •Moderate or greater behavioral problems as measured by a rating of moderate or higher (≥4) on the Clinical Global Impression-Severity (CGI-S)
排除标准
- •Planned changes in existing interventions for the duration of the trial or such a change in the last 4 weeks.
- •Current treatment with cannabis based therapy or such a treatment in the last 3 months.
- •Heart, liver, renal or hematological disorders
- •History of psychotic disorder in a first degree relative.
研究组 & 干预措施
Cannabinoids - 99% pure cannabinoids mix
Oral cannabinoids mix [cannabidiol (CBD), Δ9-tetrahydrocannabinol (THC) in a 20:1 ratio] at 1 mg/kg cannabidiol per day, up-titrated until intolerance or to a maximum dose of 10 mg/kg CBD per day, divided to 3 daily doses, for 3 months.
干预措施: Cannabinoids - 99% pure cannabinoids mix (Drug)
Placebo
Oral olive oil and flavors that mimic in texture and flavor the cannabinoids' solution.
干预措施: Placebo (Drug)
Cannabinoids - whole plant extract
Oral cannabinoids mix [cannabidiol (CBD), Δ9-tetrahydrocannabinol (THC) in a 20:1 ratio] at 1 mg/kg cannabidiol per day, up-titrated until intolerance or to a maximum dose of 10 mg/kg CBD per day, divided to 3 daily doses, for 3 months
干预措施: Cannabinoids - whole plant extract (Drug)
结局指标
主要结局
Change from baseline Home Situations Questionnaire-Autism Spectrum Disorder (HSQ-ASD) score, at three months. Within subject difference between the placebo condition and the whole plant extract condition.
时间窗: At onset of each treatment period, at 1 month, 2 months and 3 months (end of treatment period)
This is a 24-item parent-rated measure of noncompliant behavior in children with ASD
Clinical Global Impression-Improvement scores (CGI-I ) at three months. Within subject difference between the placebo condition and the whole plant extract condition.
时间窗: At 3 months (end of treatment period)
This is a 7-point scale designed to measure overall improvement from baseline (CGI-I).
次要结局
- Clinical Global Impression-Improvement scores (CGI-I ) at three months. Within subject differences between the placebo condition and the pure cannabinoids condition and between the whole plant extract condition and the pure cannabinoids condition.(At 3 months (end of treatment period))
- Change in Social Responsiveness Scale scores-2 (SRS-2, parent and teacher rated) at three months(At onset of each treatment period and at 3 months (end of treatment period))
- Change in Autism Parenting Stress Index (APSI) score, at three months(At onset of each treatment period, at 1 month, 2 months and 3 months (end of treatment period))
- Change from baseline Home Situations Questionnaire-Autism Spectrum Disorder (HSQ-ASD) score, at three months.(At onset of each treatment period, at 1 month, 2 months and 3 months (end of treatment period))
研究者
Dr. Adi Aran
Director, Neuro-pediatric unit
Shaare Zedek Medical Center