NCT06115603 The Effects of Cannabigerol on Attention-Deficit/Hyperactivity Disorder
| NCT ID | NCT06115603 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Arkansas, Fayetteville |
| Condition | Attention-Deficit/Hyperactivity Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2024-12-14 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 76 participants in total. It began in 2024-12-14 with a primary completion date of 2026-07.
⚠ 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
The goal of this clinical trial is to evaluate the effects of Cannabigerol (CBG) on indicators of Attention-Deficit/Hyperactivity Disorder (ADHD) in a sample of participants indicating/reporting symptoms associated with ADHD. The main question it aims to answer is: Does CBG reduce ADHD-related indicators relative to placebo? Participants will administer an acute dose of placebo or 80mg CBG and complete outcome measures at 45 minutes and 75 minutes. Daily surveys to monitor safety will be administered for one week following administration.
Eligibility Criteria
1. Between 18 and 55-years-old. 2. BMI between 18 and 35 kg/m2. 3. Score a 4 or above on the Adult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist Part A. 4. Meet diagnostic criteria for ADHD with a current severity rating of at least mild as defined by the DIAMOND. 5. Are not pregnant or currently breastfeeding. 6. Have no history of significant allergic condition, hypersensitivity, or allergic reactions to cannabis, cannabinoid medications, hemp products, medium chain triglyceride oil, or peppermint. 7. Have not used CBG or any other cannabinoid products in the past 30 days. 8. Willing to abstain from using cannabis or any THC-containing product for the duration of the study. 9. Have never used a synthetic cannabinoid or cannabinoid analogue (e.g., dronabinol, nabilone), or a synthetic cannabinoid receptor agonist (e.g., spice, k2). 10. Have not been exposed to any investigational drug or device 30 days prior to screening and you have no plans to take an investigational drug during the study. 11. Willing to maintain a stable treatment regimen (i.e., no change in current medication use) for the duration of the study. 12. Not currently taking a prescription medication for ADHD and have not been prescribed a medication for ADHD in the past six months. 13. Not currently having thoughts of committing suicide 14. Does not meet criteria for current severe major depressive disorder or a substance use disorder. 15. Have not been diagnosed with bipolar disorder or psychosis. 16. Do not have an acute illness, such as a respiratory infection or other illness that would interfere with study participation; not currently taking medication for an acute illness (e.g., antibiotic). 17. Do not have history of diagnosis related to liver function and/or significantly impaired liver function (e.g., cirrhosis of the liver, hepatitis). 18. Willing to ensure they have used effective contraception (for example, oral contraception, double barrier, intra-uterine device) for 30 prior to the study and for 30 days after study completion. 19. Have access to a ride to the University of Arkansas campus for research appointments. 20. Willing to comply with current university mandates as they pertain to COVID-19 protocols (e.g., mask wearing). 21. Do not have any serious or unstable physical health conditions including neurological or renal illness. 22. Do not have any current or historical cardiovascular conditions, including hypotension, bradycardia, or heart block. 23. No atrial fibrillation, bradycardia, or tachycardia detected via mobile electrocardiogram during the in-laboratory visit. 24. No recent illicit drug use other than cannabis, or alcohol use in the 12 hours preceding the in-laboratory visit. 25. Not currently prescribed or taking the following medications: * Warfarin * Clobazam * Valproic acid * Phenobarbital * Mechanistic Target of Rapamycin \[mTOR\] Inhibitors * Oral tacrolimus * St. John's wort * Epidiolex * Escitalopram * Cardiovascular medications * Strong CYP3A4 inhibitors (e.g., ketoconazole)
Contact & Investigator
Ellen W Leen-Feldner, PhD
PRINCIPAL INVESTIGATOR
University of Arkansas
Frequently Asked Questions
Who can join the NCT06115603 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Attention-Deficit/Hyperactivity Disorder. 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 NCT06115603 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06115603 currently recruiting?
Yes, NCT06115603 is actively recruiting participants. Contact the research team at eleenfe@uark.edu for enrollment information.
Where is the NCT06115603 trial being conducted?
This trial is being conducted at Fayetteville, United States.
Who is sponsoring the NCT06115603 clinical trial?
NCT06115603 is sponsored by University of Arkansas, Fayetteville. The principal investigator is Ellen W Leen-Feldner, PhD at University of Arkansas. The trial plans to enroll 76 participants.