The Safety and Efficacy of Terpene-enriched Cannabidiol (CBD) Oil in ADHD
NCT Number: NCT06542445
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Interventions: DRUG: Oral CBD oil enriched with terpenes|DRUG: Oral Placebo
Sponsor: Bazelet Nehushtan LtD.
Sex: ALL
Age: CHILD, ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-22
Completion Date: 2026-09-22
Locations: Shamir Medical Center, Zerifin, Israel

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.

Primary Outcome Measures: 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 Outcome Measures: Improvement in Conners' Parent Questionnaire - Total score, as compared with baseline., Conners' Parent Rating Scale, 5 weeks (Visit 1 to Visit 2)|Improvement in hyperactivity sub-score of the TOVA test, as compared with baseline., Computerized visual T.O.V.A, 5 weeks (Visit 1 to Visit 2)|Improvement in inattentiveness sub-score of the TOVA test, as compared with baseline., Computerized visual T.O.V.A, 5 weeks (Visit 1 to Visit 2)|Improvement in TOVA test - Total score, as compared with baseline., Computerized visual T.O.V.A, 5 weeks (Visit 1 to Visit 2)|Improvement in hyperactivity sub-score of the Conners' Teacher Questionnaire, as compared with baseline., Conners' Teacher Rating Scale, 5 weeks (Visit 1 to Visit 2)|Improvement in inattentiveness sub-score of the Conners' Teacher Questionnaire, as compared with baseline, Conners' Teacher Rating Scale, 5 weeks (Visit 1 to Visit 2)|Improvement in Conners' Teacher Questionnaire - Total score, as compared with baseline., Conners' Teacher Rating Scale, 5 weeks (Visit 1 to Visit 2)|Improvement in the scores of CBCL questionnaire, as compared with baseline., Child Behavior Checklist (CBCL), 5 weeks (Visit 1 to Visit 2)|Side effects are tolerable and transient., Side effect questionnaire, 5 weeks (Visit 1 to Visit 2)|The rate of drop-out will be similar in both groups., Drop-outs will be recorded by the study stuff., 5 weeks (Visit 1 to Visit 2)