Clinical trial NCT06115603: The Effects of Cannabigerol on Attention-Deficit/Hyperactivity Disorder
Official title: CBG and Attention: A Double-Blind, Randomized, Placebo-Controlled Trial Examining the Effects of Cannabigerol on Indicators of Attention-Deficit/Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Attention-Deficit/Hyperactivity Disorder
Lead sponsor: University of Arkansas, Fayetteville
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Primary outcomes:
measure: Sustained Attention to Response Task
timeFrame: 75 minutes post CBG/placebo administration
measure: Trail Making Test-Parts A and B (TMT-A&B)
timeFrame: 75 minutes post CBG/placebo administration
measure: Digit Symbol Substitution Test (DSST)
timeFrame: 75 minutes post CBG/placebo administration
measure: Rey Auditory Verbal Learning Test (AVLT)
timeFrame: 75 minutes post CBG/placebo administration
measure: Iowa Gambling Task (IGT)
timeFrame: 75 minutes post CBG/placebo administration
Secondary outcomes:
measure: Positive and Negative Affect Scale-Expanded Version
timeFrame: Baseline, 45 minutes post CBG/placebo administration, 75 minutes post CBG/placebo administration
measure: Karolinska Sleepiness Scale
timeFrame: Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
measure: Brief Irritability Test
timeFrame: Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
measure: Numeric Rating Scale (pain)
timeFrame: Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
measure: State-Trait Anxiety Inventory (State Version)
timeFrame: Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
measure: Visual Analog Scales
timeFrame: 75 minutes post CBG/placebo administration
measure: Global Impression of Change
timeFrame: 75 minutes post CBG/placebo administration
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Ellen W Leen-Feldner, PhD
role: PRINCIPAL_INVESTIGATOR
References: