The Effects of Cannabigerol on Attention-Deficit/Hyperactivity Disorder (CBG)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Attention-Deficit/Hyperactivity Disorder
• Intervention / Treatment: Drug: Cannabigerol; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ellen W Leen-Feldner, PhD; Phone Number: 4795754256; Email: eleenfe@uark.edu

Study Locations

• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Recruiting
      • University of Arkansas
      • Contact: Ellen Leen-Feldner, PhD; Email: eleenfe@uark.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cannabigerol; 1mL of 80mg of Cannabigerol. Cannabigerol is a safe, legal, non-high-inducing cannabinoid obtained from the cannabis plant.	Drug: Cannabigerol; 1 mL of 80mg Cannabigerol once during experimental session
Placebo Comparator: Placebo; 1mL of Placebo. Placebo is made in the form of MCT oil.	Other: Placebo; 1 mL of placebo once during experimental session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained Attention to Response Task	A computerized task that measures response inhibition.	75 minutes post CBG/placebo administration
Trail Making Test-Parts A and B (TMT-A&B)	A paper-and-pencil task that measures	75 minutes post CBG/placebo administration
Digit Symbol Substitution Test (DSST)	A paper-and-pencil task that measures attention/processing speed.	75 minutes post CBG/placebo administration
Rey Auditory Verbal Learning Test (AVLT)	A paper-and-pencil/verbal test that measures verbal memory.	75 minutes post CBG/placebo administration
Iowa Gambling Task (IGT)	A computerized task that measures decision making (an indicator of impulsivity/hyperactivity).	75 minutes post CBG/placebo administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive and Negative Affect Scale-Expanded Version	Self-report measure of positive and negative affect. Scores range from 30-150 on each of the two types of affects, with higher scores representing greater affect.	Baseline, 45 minutes post CBG/placebo administration, 75 minutes post CBG/placebo administration
Karolinska Sleepiness Scale	Self-report measure of subjective level of sleepiness at a particular time during the day. Scores range from 1-10, with higher scores representing greater sleepiness.	Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
Brief Irritability Test	Self-report measure of irritability. Scores range from 5-30, with higher scores representing greater irritability.	Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
Numeric Rating Scale (pain)	Self-report measure of subjective level of pain. Scores range from 0-10, with higher scores representing greater pain.	Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
State-Trait Anxiety Inventory (State Version)	Self-report measure of state anxiety. Scores range from 20 to 80 with higher scores indicating greater anxiety.	Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
Visual Analog Scales	Self-report of state-like states (e.g., anxiety, hunger). This scale ranges from 0 to 100 with higher scores indicating higher levels of the indication.	75 minutes post CBG/placebo administration
Global Impression of Change	Self-report measure of perceived change in ADHD symptoms. This scale ranges from 1 to 7 with higher scores indicating greater improvements.	75 minutes post CBG/placebo administration

Collaborators and Investigators

• Sponsor: University of Arkansas, Fayetteville
• Investigators: Principal Investigator: Ellen W Leen-Feldner, PhD, University of Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 29, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity; cannabigerol
• Other Study ID Numbers: 2309494774

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified, individual participant data (including data dictionaries) that underlie results reported in each published report will be shared (text, tables, figures, appendices)
• IPD Sharing Time Frame: Beginning 9months and ending 36 months following publication
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal. Inquiries should be directed to eleenfe@uark.edu; Requestors will need to sign a data agreement to gain access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No