The Safety and Efficacy of Terpene-enriched Cannabidiol (CBD) Oil in ADHD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-18
SponsorBazelet Nehushtan LtD.
About this trial
ADHD is the most frequent neurodevelopmental disorder in childhood. Symptoms often appear in preschool years, and most children (65-80%) continue to experience some ADHD-associated symptoms into adolescence and adulthood. The disorder is marked by age-inappropriate inattention, hyperactivity, and impulsivity. Drug treatments for ADHD include stimulants containing methylphenidate (like Ritalin and Concerta) or amphetamines (like Vyvanse). However, 30-35% of the patients do not respond well to these treatments, and stimulants may result with various side effects.
The use of medical cannabis increases; applied for expending medical conditions, with growing evidence for its beneficial effects. A study on ADHD adults treated by cannabinoids demonstrated improvements in hyperactivity and impulsivity.
The current study is aimed to examine the safety and efficacy of treating children diagnosed with ADHD with a CBD oil (devoid of THC), enriched with terpenes. Participants will be randomly assigned to receive either the enriched CBD oil or a placebo, for 5 weeks (Treatment, Stage I).
At the end of the treatment stage (I), an open-label stage will follow (II), wherein, all participants will receive the investigational product for an additional 5 weeks.
The investigators hypothesize that children treated with the enriched CBD oil (Treatment, Stage I) will show significantly higher improvement in hyperactivity and inattention scores, as compared with the placebo group.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children/adolescents aged 6-18 diagnosed with ADHD as per DSM-V by a neurologist, psychiatrist or other specialist.
Willing/able to arrive to all the necessary visits as per study protocol.
Disqualifiers
Participants who used ADHD conventional medications in the month before starting the study or intend to do so during the study.
Participants who used benzodiazepines or first-generation antihistamines in the week before starting the study or other drugs which may interfere with the study as per PI opinion.
Participants suffering from neurological or psychiatric diseases.
Participants suffering from neoplastic diseases.
Trial design
Design model
Parallel
Treatments tested in this trial
Oral CBD oil enriched with terpenes
DrugStage I dosing, increasing titration: days 1-2: 2.5 mg/kg BW/day; days 3-4: 5 mg/kg BW/day; day 5-7: 7.5 mg/kg BW/day; days 8-35: 10 mg/kg BW/day. Stage II dosing, increasing titration: days 36-37: 2.5 mg/kg BW/day; days 38-39: 5 mg/kg BW/day; day 40-42: 7.5 mg/kg BW/day; days 43-70:10 mg/kg BW/day.
Oral Placebo
DrugOral placebo oil that is similar in appearance and taste to the CBD oil. Titration and dosing identical to those described for the CBD oil.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: CBD oil enriched with terpenesActive comparator 1 intervention
Group B: Placebo oilPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Improvement in hyperactivity sub-score of the Conners' Parent Questionnaire, as compared with baseline.
Conners' Parent Rating Scale
Time frame
5 weeks (Visit 1 to Visit 2)2
Improvement in inattentiveness sub-score of the Conners' Parent Questionnaire, as compared with baseline.
Conners' Parent Rating Scale
Time frame
5 weeks (Visit 1 to Visit 2)Secondary outcomes
1
Improvement in Conners' Parent Questionnaire - Total score, as compared with baseline.
Conners' Parent Rating Scale
Time frame
5 weeks (Visit 1 to Visit 2)2
Improvement in hyperactivity sub-score of the TOVA test, as compared with baseline.
Computerized visual T.O.V.A
Time frame
5 weeks (Visit 1 to Visit 2)3
Improvement in inattentiveness sub-score of the TOVA test, as compared with baseline.
Computerized visual T.O.V.A
Time frame
5 weeks (Visit 1 to Visit 2)4
Improvement in TOVA test - Total score, as compared with baseline.
Computerized visual T.O.V.A
Time frame
5 weeks (Visit 1 to Visit 2)Sponsors and contacts
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Source ClinicalTrials.gov