RecruitingPhase 1Phase 2NCT07592390

Cannabigerol Oil for Adolescents With ADHD (CAN-ADHD)

Potential Effects of Cannabigerol in Adolescents With Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial (CAN-ADHD)


Sponsor

Universidade do Sul de Santa Catarina

Enrollment

60 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 12 YearsMax Age: 17 Years

Inclusion Criteria6

  • Adolescents aged 12 to 17 years
  • Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD) confirmed using the SNAP-IV (Swanson, Nolan and Pelham Questionnaire, version IV)
  • History of previous treatment with pharmacological or non-pharmacological interventions without significant improvement of symptoms
  • Absence of severe psychiatric disorders or relevant physical comorbidities
  • Ability of the participant and legal guardian to understand study procedures
  • Provision of written informed consent by the legal guardian and assent by the adolescent

Exclusion Criteria6

  • Use of cannabinoid-based substances (natural or synthetic) within 30 days prior to study initiation
  • History of intolerance or adverse reactions to cannabis-derived compounds (e.g., confusion, paranoia, pruritus, excessive drowsiness, vomiting, diarrhea, or seizures)
  • Presence of any significant physical comorbidity
  • Presence of severe psychiatric disorder not related to ADHD
  • Moderate to severe cognitive impairment
  • Inability or unwillingness to complete study procedures or questionnaires adequately

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Interventions

DRUGExperimental: 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.

DRUGPlacebo 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.


Locations(1)

Universidade do Sul de Santa Catarina - UNISUL

Tubarão, Santa Catarina, Brazil

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NCT07592390


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