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Cannabigerol Oil for Adolescents With ADHD (CAN-ADHD)

NCT07592390 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-18

No results posted yet for this study

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)

Interventions

DRUG

Experimental: 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.

DRUG

Placebo 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.

Sponsors & Collaborators

  • Associação Brasileira de Cannabis Medicinal

    collaborator OTHER

  • Universidade do Sul de Santa Catarina

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-12-18
Completion
2026-12-18

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07592390 on ClinicalTrials.gov