Effects of Cannabigerol on ADHD symptoms

CBG and Attention: A Double-Blind, Randomized, Placebo-Controlled Trial Examining the Effects of Cannabigerol on Indicators of Attention-Deficit/Hyperactivity Disorder

This study is testing if Cannabigerol (CBG) can help reduce ADHD symptoms in adults aged 18 to 55 compared to a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: University of Arkansas, Fayetteville (Academic / other)
• Locations: 1 site (Fayetteville, Arkansas)
• Trial ID: NCT06115603 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the impact of Cannabigerol (CBG) on symptoms associated with Attention-Deficit/Hyperactivity Disorder (ADHD). Participants aged 18 to 55 will receive either an acute dose of 80mg CBG or a placebo, with their ADHD-related indicators assessed at 45 and 75 minutes post-administration. Daily safety surveys will be conducted for one week following the dose to monitor any adverse effects. The primary aim is to determine if CBG can effectively reduce ADHD symptoms compared to a placebo.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 55 with a diagnosis of ADHD and mild to moderate symptoms.

Not a fit: Patients with severe ADHD symptoms or those who have recently used cannabinoid products may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new therapeutic option for managing ADHD symptoms.

How similar studies have performed: While the use of cannabinoids for ADHD is a novel approach, preliminary studies on cannabinoids for other conditions have shown promise.

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)

Where this trial is running

Fayetteville, Arkansas

• University of Arkansas — Fayetteville, Arkansas, United States (Recruiting)

Study contacts

• Principal investigator: Ellen W Leen-Feldner, PhD — University of Arkansas
• Study coordinator: Ellen W Leen-Feldner, PhD

Conditions Attention-Deficit/Hyperactivity Disorder