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RECRUITING

NCT06542445

PHASE2

The Safety and Efficacy of Terpene-enriched Cannabidiol (CBD) Oil in ADHD

Sponsor: Bazelet Nehushtan LtD.

View on ClinicalTrials.gov

Summary

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.

Official title: The Safety and Efficacy of Treatment With Cannabidiol (CBD) Oil Enriched With Terpenes, Devoid of THC, in Children Diagnosed With ADHD

Key Details

Gender

All

Age Range

6 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-08-22

Completion Date

2026-09-22

Last Updated

2024-08-23

Healthy Volunteers

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

DRUG

Oral CBD oil enriched with terpenes

Stage 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.

DRUG

Oral Placebo

Oral placebo oil that is similar in appearance and taste to the CBD oil. Titration and dosing identical to those described for the CBD oil.

Inclusion Criteria: 1. Children/adolescents aged 6-18 diagnosed with ADHD as per DSM-V by a neurologist, psychiatrist or other specialist. 2. Willing/able to arrive to all the necessary visits as per study protocol. Exclusion Criteria: 1. Participants who used ADHD conventional medications in the month before starting the study or intend to do so during the study. 2. 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. 3. Participants suffering from neurological or psychiatric diseases. 4. Participants suffering from neoplastic diseases. 5. Participants with syndromes or metabolic diseases. 6. Participants with a significant clinic diagnosis which may interfere with the study. May be included later on as per PI opinion. 7. Pregnant or breastfeeding adolescents. 8. Sexually active female adolescents who are unwilling to use contraceptives. 9. Participants that in the PI opinion will not comply with the protocol in a way that will harm the study (for ex.: not using contraceptives.) 10. Participants with less than 18 kg or more than 90 kg weight. 11. Participants with BMI lower than 18 or higher than 29.9. 12. Participants engaged in another clinical study which includes a medicine. 13. Participants engaged in another study regarding ADHD treatment of any kind. 14. Participants using alcohol or drugs. 15. Past or present use of Cannabis, including medical cannabis Criteria for early termination: 1. Use of another medication for ADHD during the study. 2. Use of a medication from the exclusion criteria list during the study. 3. Use of alcohol or drugs during the study. 4. Participants who got pregnant during the study. 5. Participants who split the first visit and did not arrive to the second part of the first visit after a maximum of 28 days. 6. Participants who did not start the treatment during the 14 days from receiving the drug. 7. Non -compliant participants. Criteria for exchange: 1. PI may exchange participants that quit, if they did not start treatment for new participants. 2. PI may recruit again participants who quit after a new full recruitment process.

Locations (1)

Shamir Medical Center

Ẕerifin, Israel