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

NCT06542445 | Recruiting Phase 2

• 1 other identifier: ASF-0243-22
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

Cannabidiol; Terpenes; Medical Cannabis; Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (2)

• Improvement in hyperactivity sub-score of the Conners' Parent Questionnaire, as compared with baseline.

  Conners' Parent Rating Scale

  5 weeks (Visit 1 to Visit 2)

• Improvement in inattentiveness sub-score of the Conners' Parent Questionnaire, as compared with baseline.

  Conners' Parent Rating Scale

  5 weeks (Visit 1 to Visit 2)

Secondary Outcomes (10)

• Improvement in Conners' Parent Questionnaire - Total score, as compared with baseline.

  5 weeks (Visit 1 to Visit 2)

• Improvement in hyperactivity sub-score of the TOVA test, as compared with baseline.

  5 weeks (Visit 1 to Visit 2)

• Improvement in inattentiveness sub-score of the TOVA test, as compared with baseline.

  5 weeks (Visit 1 to Visit 2)

• Improvement in TOVA test - Total score, as compared with baseline.

  5 weeks (Visit 1 to Visit 2)

• Improvement in hyperactivity sub-score of the Conners' Teacher Questionnaire, as compared with baseline.

  5 weeks (Visit 1 to Visit 2)

Study Arms (2)

CBD oil enriched with terpenes

ACTIVE COMPARATOR

24% CBD, terpenes, MCT oil.

Drug: Oral CBD oil enriched with terpenes

Placebo oil

PLACEBO COMPARATOR

fragrances and flavors, MCT oil.

Drug: Oral Placebo

Interventions

Oral CBD oil enriched with terpenes DRUG

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.

CBD oil enriched with terpenes

Oral Placebo DRUG

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.

Placebo oil

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Participants with syndromes or metabolic diseases.
• Participants with a significant clinic diagnosis which may interfere with the study. May be included later on as per PI opinion.
• Pregnant or breastfeeding adolescents.
• Sexually active female adolescents who are unwilling to use contraceptives.
• 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.)
• Participants with less than 18 kg or more than 90 kg weight.
• Participants with BMI lower than 18 or higher than 29.9.
• Participants engaged in another clinical study which includes a medicine.
• Participants engaged in another study regarding ADHD treatment of any kind.
• Participants using alcohol or drugs.
• Past or present use of Cannabis, including medical cannabis

Sponsors & Collaborators

• Bazelet Nehushtan LtD.: lead

Study Sites (1)

Shamir Medical Center

Ẕerifin, Israel

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Terpenes

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Hydrocarbons; Organic Chemicals

Study Officials

• Matitiahu Berkovitch, MD

  Shamir Medical Center, Zerifin, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariela Hazan

CONTACT

+972-89778465; arielah@shamir.gov.il

Elkana Kohn, PhD

CONTACT

+972-89542181; elkanak@shamir.gov.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All blinded except dispensing pharmacist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each participant will be randomly assigned to receive either the terpene-enriched CBD oil or a placebo for 5 weeks.

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 7, 2024
• Study Start: August 22, 2024
• Primary Completion (Estimated): August 22, 2026
• Study Completion (Estimated): September 22, 2026
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

IL (1)