The Effects of Cannabigerol on Attention-Deficit/Hyperactivity Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-14

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment With Cannabis Oil Containing CBD, THC, CBDV or CBG vs. Placebo of Persons With ADHD

NCT05219370

ADHD Hyperactivity Attention Deficit

TERMINATED PHASE2

Treatment of Cannabis Use Disorder Among Adults With Comorbid Attention-Deficit/Hyperactivity Disorder

NCT02803229

Cannabis Use Disorder Attention-deficit/Hyperactivity Disorder

COMPLETED PHASE2/PHASE3

Experimental Medicine in ADHD - Cannabinoids

NCT02249299

Attention Deficit Hyperactivity Disorder (ADHD)

COMPLETED NA

Safety & Efficacy of TC-5619 in Adults With Inattentive-predominant Attention Deficit/Hyperactivity Disorder (ADHD)

NCT01472991

Attention Deficit Hyperactivity Disorder

COMPLETED PHASE2

Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder

NCT00050050

Attention Deficit Disorder With Hyperactivity

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Attention-Deficit/Hyperactivity Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cannabigerol

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

Group Type ACTIVE_COMPARATOR

Cannabigerol

Intervention Type DRUG

1 mL of 80mg Cannabigerol once during experimental session

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

1 mL of placebo once during experimental session

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cannabigerol

1 mL of 80mg Cannabigerol once during experimental session

Intervention Type DRUG

Placebo

1 mL of placebo once during experimental session

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes