Treatment With Cannabis Oil Containing Canabidiol (CBD) Tetrahydrocannabinol (THC), Cannabidivarin (CBDV) or Cannabigerol (CBG) vs. Placebo of Persons Diagnosed With ADHD After Failure of Conventional Treatment
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- efficacy of cannabis oil on ADHD symptoms as per TOVA test
研究概览
简要总结
ADHD is the most frequent neuro-developmental disorder in childhood and often continues into adolescence and adulthood.
Indicated drug treatments for ADHD fall into 2 categories: stimulants (such as methylphenidate and amphetamines) and non-stimulants (such as atomoxetine, guanfacine and clonidine) but some persons cannot tolerate their secondary effects or find them non-effective.
In the last decade, medical cannabis products have been researched as possible treatment for neurological and mental diseases such as: Post trauma disorder (PTD), autism (ASD), epilepsy, fibromyalgia (FM) and more.
Data on the effects of cannabidiol rich cannabis extract use for ADHD seems promising but is still limited. The aim of this study is to investigate if oral cannabinoids given to adults with ADHD affect the symptoms of the disorder.
The main objectives of the study are: 1) to characterize the effects of treatment with cannabis oil on symptoms of ADHD; 2) to compare safety and efficacy of cannabis oil products with different CBD,Cannabidivarin (CBDV), cannabigerol (CBG) and THC ratio; 3) and to measure endocannabinoids, THC and CBD and metabolites levels in the blood of the participants.
In this study, participants diagnosed with ADHD will be treated with canabidiol-rich cannabis oil and will follow up weekly during approx.1 month (the study period). Blood tests will be performed before and after treatment. Blood tests include blood count, blood chemistry, hormones profile, phyto- and endo- cannabinoids and their metabolites. Test of Variables of Attention test (TOVA) will be administrated before and after treatment
详细描述
Participants will be screened by study staff for ADHD diagnosis and failure of conventional treatment.
Participants passing the screening will undergo blood and urine tests, fill questionnaires, TOVA test and will be randomized to one of the 4 arms.
Participants will receive the drug, be instructed as per dose titration and as per danger of driving under drug influence.
Telephone follow up will take place weekly after 7 days from starting. Participants will guess to which arm the participant was allocated to after 2 weeks of treatment .
Participants will arrive for a last visit, fill questionnaires, do TOVA test and undergo blood and urine tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
the responsible pharmacist is un-blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged at least 18 y/o diagnosed with ADHD by Diagnostic and Statistical Manual of Mental Disorders (DSM)
- •Participants with a lower than 0 TOVA score or with a higher than 0 score whom as per investigator opinion suffer from ADHD
- •Participants who experienced treatment failure with more than one ADHD conventional drug
- •Participants willing to attend all the visits in the trial.
排除标准
- •Participants who were treated with benzodiazepines, antihistamines, etc, in the week that preceded the trial start.
- •Participants suffering from neurologic or psychiatric diseases
- •Participants suffering from malignant diseases
- •Participants suffering from syndromes or metabolic diseases
- •Participants with significant clinical diagnosis that can damage the trial unfolding. The investigator may include them after the end of the situation which prevented their previous inclusion.
- •Participants breastfeeding, pregnant or not willing to use contraceptives.
- •Participants that will not adhere to the protocol as per investigator opinion
- •Participants who weight less than 45 kg or more than 120kg or with BMI greater than 30
- •Participants participating in another clinical trial which includes drug treatment
- •Participants receiving any treatment for ADHD
- •Participants using drugs
- •Participants using cannabis or products containing cannabinoids, including medical cannabis.
研究组 & 干预措施
CBD rich
Cannabis oil oral drops containing 95 mg/ml CBD; 5 mg/ml THC; 15 mg/ml CBDV ; no CBG, once daily Titration from 0.3 to 1.8 ml/day during 21 days
干预措施: Cannabis oil (Drug)
CBG rich
Cannabis oil oral drops containing no CBD; 5 mg/ml THC; no CBDV; 95 mg/ml CBG, once daily.
Titration from 0.3 to 1.8 ml/day during 21 days
干预措施: Cannabis oil (Drug)
CBD & CBG rich
Cannabis oil oral drops containing 47.5 mg/ml CBD; 2.5 mg/ml THC; 7.5 mg/ml CBDV; 47.5 mg/ml CBG, once daily.
Titration from 0.3 to 1.8 ml/day during 21 days
干预措施: Cannabis oil (Drug)
placebo
Placebo oil oral drops once daily. Titration from 0.3 to 1.8 ml/day during 21 days
干预措施: Cannabis oil (Drug)
结局指标
主要结局
efficacy of cannabis oil on ADHD symptoms as per TOVA test
时间窗: 30-35 days
To assess if participants treated with cannabis oil show an improvement in TOVA scores
efficacy of cannabis oil on ADHD symptoms as per Conners questionnaire
时间窗: 30-35 days
To assess if participants treated with cannabis oil show an improvement in Conners score
次要结局
- number of participants who dropped-out(60 days)
- to assess side effects and their severity using questionnaire(60 days)