Cannabigerol Oil for Adolescents With ADHD (CAN-ADHD)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12-17
SponsorUniversidade do Sul de Santa Catarina
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Experimental: Full-spectrum CBG oil 30 mg/mL
- Placebo oil (MCT oil)
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Universidade do Sul de Santa Catarina
Lead sponsor
Associação Brasileira de Cannabis Medicinal
Collaborator
Source ClinicalTrials.gov