The Effects of Cannabigerol on Attention-Deficit/Hyperactivity Disorder

NCT06115603 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 2309494774
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention-Deficit/Hyperactivity Disorder

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Positive and Negative Affect Scale-Expanded Version

  Baseline, 45 minutes post CBG/placebo administration, 75 minutes post CBG/placebo administration

• Karolinska Sleepiness Scale

  Pre CBG/placebo administration, 75 minutes post CBG/placebo administration

• Brief Irritability Test

  Pre CBG/placebo administration, 75 minutes post CBG/placebo administration

• Numeric Rating Scale (pain)

  Pre CBG/placebo administration, 75 minutes post CBG/placebo administration

• State-Trait Anxiety Inventory (State Version)

  Pre CBG/placebo administration, 75 minutes post CBG/placebo administration

Study Arms (2)

Cannabigerol

ACTIVE COMPARATOR

1mL of 80mg of Cannabigerol. Cannabigerol is a safe, legal, non-high-inducing cannabinoid obtained from the cannabis plant.

Drug: Cannabigerol

Placebo

PLACEBO COMPARATOR

1mL of Placebo. Placebo is made in the form of MCT oil.

Other: Placebo

Interventions

Cannabigerol DRUG

1 mL of 80mg Cannabigerol once during experimental session

Cannabigerol

Placebo OTHER

1 mL of placebo once during experimental session

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Arkansas, Fayetteville: lead

Study Sites (1)

University of Arkansas

Fayetteville, Arkansas, 72703, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

cannabigerol

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Ellen W Leen-Feldner, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellen W Leen-Feldner, PhD

CONTACT

4795754256; eleenfe@uark.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and researchers interacting with participants will be blind to condition. An unblinded researcher team will randomize and label all pipettes containing CBG or placebo prior to each participants' session. Participants will receive individual, 1 mL pipettes containing CBG and placebo (pipettes are indistinguishable).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: November 3, 2023
• Study Start: December 14, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 9months and ending 36 months following publication
• 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

Locations

US (1)