The Effects of Cannabigerol on Attention-Deficit/Hyperactivity Disorder

Launched by UNIVERSITY OF ARKANSAS, FAYETTEVILLE · Oct 29, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of a compound called Cannabigerol (CBG) on symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD). The main question is whether taking CBG can help reduce symptoms compared to a placebo, which is a substance with no active medication. If you are between 18 and 55 years old, have been diagnosed with ADHD, and meet certain health criteria, you might be eligible to participate. It's important to note that you should not be using any ADHD medications or certain other drugs during the study.

Participants will take either an 80mg dose of CBG or a placebo and then complete surveys to assess their symptoms at specific times afterward. Additionally, for safety monitoring, participants will fill out daily surveys for a week following the dose. This trial is currently recruiting, and anyone interested will need to ensure they meet the eligibility requirements and agree to follow specific guidelines throughout the study.

Gender

ALL

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)