Cannabigerol Oil for Adolescents With ADHD (CAN-ADHD)

Condition(s) studied

Investigational drug(s) / intervention(s)

Experimental: Full-spectrum CBG oil 30 mg/mL: Full-spectrum Cannabis sativa extract containing cannabigerol (CBG) 30 mg/mL, cannabidiol (CBD) 30 mg/mL, and tetrahydrocannabinol (THC) 3 mg/mL, administered sublingually for 12 weeks according to a structured dose titration schedule. Treatment will begin with low doses and may be gradually adjusted based on clinical response and tolerability, respecting predefined safety limits established in the study protocol.

Placebo oil (MCT oil): Placebo comparator consisting of medium-chain triglyceride (MCT) oil administered sublingually for 12 weeks according to the same dose titration schedule used in the experimental group. The placebo formulation is matched to the active intervention in appearance, color, viscosity, packaging, and administration conditions to maintain blinding throughout the study.

Study summary

This study aims to evaluate the potential effects of full-spectrum cannabigerol (CBG) oil on cognitive and behavioral symptoms in adolescents diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD). ADHD is a neurodevelopmental disorder characterized by inattention, hyperactivity, and impulsivity, often associated with impairments in academic, social, and emotional functioning.

This is a randomized, double-blind, placebo-controlled clinical trial with a parallel design. A total of 60 adolescents aged 12 to 17 years, diagnosed with ADHD and with insufficient response to previous treatments, will be enrolled and randomly assigned to either the intervention group or the placebo group.

Participants in the intervention group will receive full-spectrum CBG oil (30 mg/mL), administered sublingually, with individualized dosing determined by the study physician and adjusted through weekly monitoring. The placebo group will receive an inert oil matched in appearance and administration conditions.

The intervention will last for 12 weeks, including in-person clinical assessments at baseline, week 6, and week 12, as well as weekly remote monitoring to assess adherence, safety, and dose adjustments.

Primary outcomes will include changes in ADHD symptom severity measured by the SNAP-IV scale. Secondary outcomes will assess quality of life, emotional symptoms, sleep patterns, and safety profile.

This study aims to contribute to the scientific understanding of cannabinoids as a potential therapeutic option for adolescents with ADHD, a population for which current evidence remains limited.

Eligibility

Primary outcome measure(s)

• Change in Attention-Deficit/Hyperactivity Disorder symptom severity assessed by the Swanson, Nolan and Pelham Questionnaire, version IV — Baseline, Week 6, and Week 12
  Evaluation of longitudinal changes in Attention-Deficit/Hyperactivity Disorder symptom severity using the Swanson, Nolan and Pelham Questionnaire, version IV. The Attention-Deficit/Hyperactivity Disorder symptom score includes 18 core items rated from 0 to 3, with total scores ranging from 0 to 54. Higher scores indicate greater symptom severity.

Trial sites (1)

More Universidade do Sul de Santa Catarina trials in Brazil