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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Experimental: Full-spectrum CBG oil 30 mg/mL
DrugFull-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)
DrugPlacebo 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Full-spectrum CBG oil 30 mg/mLExperimental treatment 1 intervention
Group B: Placebo (MCT oil)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Attention-Deficit/Hyperactivity Disorder symptom severity assessed by the Swanson, Nolan and Pelham Questionnaire, version IV
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.
Time frame
Baseline, Week 6, and Week 12Secondary outcomes
1
Change in quality of life of legal guardians assessed by the 36-Item Short Form Health Survey
Evaluation of longitudinal changes in legal guardians' quality of life using the 36-Item Short Form Health Survey. Scores are transformed into eight domain scores ranging from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame
Baseline, Week 6, and Week 122
Change in emotional symptoms assessed by the Depression Anxiety and Stress Scale for Children
Evaluation of longitudinal changes in symptoms of depression, anxiety, and stress using the Depression Anxiety and Stress Scale for Children. Total scores range from 0 to 63, with higher scores indicating greater emotional symptom severity.
Time frame
Baseline, Week 6, and Week 123
Change in sleep patterns assessed by the Children's Sleep Habits Questionnaire
Evaluation of longitudinal changes in sleep behavior using the Children's Sleep Habits Questionnaire. Total scores range from 33 to 99, with higher scores indicating more sleep problems.
Time frame
Baseline, Week 6, and Week 124
Number of participants with treatment-related adverse events assessed by the study adverse effects questionnaire
Assessment of safety through the number of participants reporting adverse events using the study adverse effects questionnaire. Each adverse event is recorded as present or absent, and severity is classified as mild, moderate, or intense. A higher number of reported adverse events indicates worse tolerability.
Time frame
Weekly monitoring during 12 weeks and clinical assessments at Baseline, Week 6, and Week 12Other outcomes
1
Number of missed doses reported during weekly remote monitoring
Assessment of treatment adherence based on caregiver reports during weekly remote monitoring. The outcome will be reported as the number of missed doses during the 12-week intervention period. A higher number of missed doses indicates lower treatment adherence.
Time frame
Weekly during 12 weeks2
Number of participants requiring dose adjustment during the intervention period
Assessment of dose adjustment patterns based on weekly remote monitoring and clinical evaluation. The outcome will be reported as the number of participants requiring dose reduction, delay in titration, or dose increase during the 12-week intervention period.
Time frame
Weekly during 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidade do Sul de Santa Catarina
Lead sponsor
Associação Brasileira de Cannabis Medicinal
Collaborator
Source ClinicalTrials.gov