Status:
RECRUITING
The Effects of Cannabigerol on Attention-Deficit/Hyperactivity Disorder
Lead Sponsor:
University of Arkansas, Fayetteville
Conditions:
Attention-Deficit/Hyperactivity Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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 sympt...
Eligibility Criteria
Inclusion
- Between 18 and 55-years-old.
- BMI between 18 and 35 kg/m2.
- Score a 4 or above on the Adult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist Part A.
- Meet diagnostic criteria for ADHD with a current severity rating of at least mild as defined by the DIAMOND.
- Are not pregnant or currently breastfeeding.
- Have no history of significant allergic condition, hypersensitivity, or allergic reactions to cannabis, cannabinoid medications, hemp products, medium chain triglyceride oil, or peppermint.
- Have not used CBG or any other cannabinoid products in the past 30 days.
- Willing to abstain from using cannabis or any THC-containing product for the duration of the study.
- Have never used a synthetic cannabinoid or cannabinoid analogue (e.g., dronabinol, nabilone), or a synthetic cannabinoid receptor agonist (e.g., spice, k2).
- 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.
- Willing to maintain a stable treatment regimen (i.e., no change in current medication use) for the duration of the study.
- Not currently taking a prescription medication for ADHD and have not been prescribed a medication for ADHD in the past six months.
- Not currently having thoughts of committing suicide
- Does not meet criteria for current severe major depressive disorder or a substance use disorder.
- Have not been diagnosed with bipolar disorder or psychosis.
- 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).
- Do not have history of diagnosis related to liver function and/or significantly impaired liver function (e.g., cirrhosis of the liver, hepatitis).
- 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.
- Have access to a ride to the University of Arkansas campus for research appointments.
- Willing to comply with current university mandates as they pertain to COVID-19 protocols (e.g., mask wearing).
- Do not have any serious or unstable physical health conditions including neurological or renal illness.
- Do not have any current or historical cardiovascular conditions, including hypotension, bradycardia, or heart block.
- No atrial fibrillation, bradycardia, or tachycardia detected via mobile electrocardiogram during the in-laboratory visit.
- No recent illicit drug use other than cannabis, or alcohol use in the 12 hours preceding the in-laboratory visit.
- 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)
Exclusion
Key Trial Info
Start Date :
December 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06115603
Start Date
December 14 2024
End Date
December 1 2025
Last Update
April 2 2025
Active Locations (1)
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1
University of Arkansas
Fayetteville, Arkansas, United States, 72703