Cannabigerol Oil for Adolescents With ADHD (CAN-ADHD)

NCT07592390 | Recruiting Phase 1

• 1 other identifier: CEP-8.184.472
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Keywords

ADHD; Cannabigerol; Cannabinoids; Adolescents

Outcome Measures

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.

  Baseline, Week 6, and Week 12

Secondary Outcomes (4)

• Change in quality of life of legal guardians assessed by the 36-Item Short Form Health Survey

  Baseline, Week 6, and Week 12

• Change in emotional symptoms assessed by the Depression Anxiety and Stress Scale for Children

  Baseline, Week 6, and Week 12

• Change in sleep patterns assessed by the Children's Sleep Habits Questionnaire

  Baseline, Week 6, and Week 12

• Number of participants with treatment-related adverse events assessed by the study adverse effects questionnaire

  Weekly monitoring during 12 weeks and clinical assessments at Baseline, Week 6, and Week 12

Other Outcomes (2)

• Number of missed doses reported during weekly remote monitoring

  Weekly during 12 weeks

• Number of participants requiring dose adjustment during the intervention period

  Weekly during 12 weeks

Study Arms (2)

Full-spectrum CBG oil 30 mg/mL

EXPERIMENTAL

Participants allocated to this arm will receive sublingual administration of full-spectrum cannabigerol oil for 12 weeks under double-blind conditions. The formulation contains cannabigerol, cannabidiol, and a low concentration of tetrahydrocannabinol. Clinical assessments will be performed at baseline, Week 6, and Week 12, with weekly remote monitoring to evaluate adherence, tolerability, adverse events, and the need for dose adjustments.

Drug: Experimental: Full-spectrum CBG oil 30 mg/mL

Placebo (MCT oil)

PLACEBO COMPARATOR

Participants allocated to this arm will receive sublingual administration of placebo oil for 12 weeks under double-blind conditions. The placebo formulation consists of medium-chain triglyceride (MCT) oil matched to the experimental product in appearance, viscosity, color, and administration schedule. Clinical assessments will be performed at baseline, Week 6, and Week 12, with weekly remote monitoring to evaluate adherence, tolerability, adverse events, and the need for dose adjustments.

Drug: Placebo oil (MCT oil)

Interventions

Experimental: Full-spectrum CBG oil 30 mg/mL DRUG

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.

Full-spectrum CBG oil 30 mg/mL

Placebo oil (MCT oil) DRUG

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.

Placebo (MCT oil)

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade do Sul de Santa Catarina: lead
• Associação Brasileira de Cannabis Medicinal: collaborator

Study Sites (1)

Universidade do Sul de Santa Catarina - UNISUL

Tubarão, Santa Catarina, 88704900, Brazil

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Rafael Mariano Bitencourt, PhD

CONTACT

+55 48 9 8833-6460; bitencourtrm@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants, legal guardians, investigators, healthcare providers, outcome assessors, and members of the research team responsible for follow-up and data analysis will remain blinded to treatment allocation throughout the study. The placebo formulation will be matched to the active intervention in appearance, color, viscosity, packaging, and administration schedule to maintain blinding conditions. Treatment allocation codes will be restricted to designated personnel not directly involved in participant assessments or clinical follow-up and will only be accessed in cases of medical necessity or after study completion.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is designed as a randomized, double-blind, placebo-controlled clinical trial with a parallel-group assignment. Participants will be randomly allocated in a 1:1 ratio to either the intervention group receiving full-spectrum cannabigerol (CBG) oil or the placebo group receiving medium-chain triglyceride (MCT) oil matched in appearance and administration conditions. Participants will remain in their assigned group throughout the 12-week intervention period, with no crossover between treatments. Clinical assessments will be conducted at baseline, week 6, and week 12, complemented by weekly remote monitoring to evaluate treatment adherence, tolerability, adverse events, and dose adjustments.

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 18, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 18, 2026
• Study Completion (Estimated): December 18, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

BR (1)