NCT07592390 Cannabigerol Oil for Adolescents With ADHD (CAN-ADHD)
| NCT ID | NCT07592390 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Universidade do Sul de Santa Catarina |
| Condition | Attention-Deficit/Hyperactivity Disorder (ADHD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-05-01 |
| Primary Completion | 2026-12-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2026-05-01 with a primary completion date of 2026-12-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07592390 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 17 Years, studying Attention-Deficit/Hyperactivity Disorder (ADHD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07592390 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07592390 currently recruiting?
Yes, NCT07592390 is actively recruiting participants. Contact the research team at bitencourtrm@gmail.com for enrollment information.
Where is the NCT07592390 trial being conducted?
This trial is being conducted at Tubarão, Brazil.
Who is sponsoring the NCT07592390 clinical trial?
NCT07592390 is sponsored by Universidade do Sul de Santa Catarina. The trial plans to enroll 60 participants.