Cannabigerol for ADHD

(CBG Trial)

Overseen By Ellen W Leen-Feldner, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Arkansas, Fayetteville

Must not be taking: Warfarin, Clobazam, Valproic acid, others

Disqualifiers: Pregnancy, Bipolar, Psychosis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

76 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you maintain a stable treatment regimen, meaning you should not change your current medication use during the study. However, you cannot participate if you are currently taking certain medications like Warfarin, Clobazam, or Escitalopram, among others.

What data supports the effectiveness of the drug Cannabigerol (CBG) for ADHD?

While there is no direct evidence for CBG's effectiveness in treating ADHD, some studies suggest that cannabinoids, including CBG, may help with symptoms like anxiety and depression, which are often associated with ADHD. Additionally, other cannabinoids have shown potential benefits for ADHD symptoms in case reports. ^{1 2 3 4 5}

Is Cannabigerol (CBG) safe for use in humans?

There is no specific safety data available for Cannabigerol (CBG) in the provided research articles. However, related compound Cannabidiol (CBD) has been associated with some adverse effects like sleep disturbances and potential interactions with other medications. More research is needed to determine the safety of CBG in humans. ^{6 7 8 9 10}

How does the drug Cannabigerol (CBG) differ from other treatments for ADHD?

Cannabigerol (CBG) is unique because it interacts with specific receptors in the brain, such as alpha-2 adrenoceptors and 5-HT1A receptors, which are not typically targeted by standard ADHD medications. Unlike other cannabinoids, CBG does not have psychotropic effects and is being explored for its potential benefits in treating various neurological disorders, making it a novel option for ADHD treatment. ^{1 2 3 11 12}

Research Team

Ellen W Leen-Feldner, PhD

Principal Investigator

University of Arkansas

Eligibility Criteria

This trial is for adults aged 18-55 with ADHD who are not pregnant or breastfeeding, have a BMI of 18-35, and agree to avoid cannabis products during the study. They must have at least mild ADHD severity and no history of significant allergies or reactions to cannabis-related substances.

Inclusion Criteria

You have no prior record of significant allergic responses to cannabis, cannabinoid medications, hemp products, medium chain triglyceride oil, or peppermint.

I have been diagnosed with ADHD, and it is at least mild in severity.

Your body mass index falls between 18 and 35 kilograms per square meter.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive an acute dose of placebo or 80mg CBG and complete outcome measures at 45 minutes and 75 minutes

1 day

1 visit (in-person)

Follow-up

Daily surveys to monitor safety are administered for one week following administration

1 week

Treatment Details

Interventions

• Cannabigerol

Trial Overview The trial tests if Cannabigerol (CBG), a compound from the cannabis plant, can reduce symptoms of ADHD compared to a placebo. Participants will take an acute dose of either CBG or placebo and their symptoms will be measured at two time points post-dosage.

Participant Groups

Group I: Cannabigerol Active Control 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Arkansas, Fayetteville

Lead Sponsor

Trials

24

Recruited

2,100+

Findings from Research

A survey of 127 CBG-predominant cannabis users revealed that most use it for medical purposes, particularly for treating anxiety, chronic pain, depression, and insomnia, with many reporting significant improvements in their conditions.

The study found a favorable safety profile for CBG, with 44% of users reporting no adverse effects and only a small percentage experiencing mild symptoms, suggesting that CBG-predominant cannabis may be a viable alternative to conventional medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of Patients Employing Cannabigerol-Predominant Cannabis Preparations: Perceived Medical Effects, Adverse Events, and Withdrawal Symptoms. Russo, EB., Cuttler, C., Cooper, ZD., et al.[2023]

Cannabigerol (CBG) shows potential therapeutic benefits for neurological disorders and inflammatory bowel disease, with unique interactions at cannabinoid receptors and other receptors like α-2 adrenoceptors and 5-HT1A.

Despite its promising effects, CBG is largely unregulated and under-researched compared to other cannabinoids like CBD, highlighting the need for further studies to understand its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pharmacological Case for Cannabigerol. Nachnani, R., Raup-Konsavage, WM., Vrana, KE.[2021]

Cannabigerol (CBG) is a non-psychoactive cannabinoid that shows promise for various therapeutic applications, including reducing intraocular pressure and exhibiting anti-inflammatory and anti-tumoral effects, based on pre-clinical studies.

CBG acts as a partial agonist at cannabinoid receptors and interacts with other receptors, suggesting it could be a valuable component in developing treatments for conditions like anxiety and neuroprotection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological Aspects and Biological Effects of Cannabigerol and Its Synthetic Derivatives. Calapai, F., Cardia, L., Esposito, E., et al.[2022]

A 33-year-old male patient with ADHD found significant symptom relief using cannabinoid therapeutics (CT), specifically Bedrocan® and Bediol®, after experiencing adverse effects from traditional ADHD medications over a 5-year period.

Bedrocan®, which contains Δ9-THC, helped alleviate symptoms like frustration tolerance and concentration issues, while Bediol®, containing both Δ9-THC and cannabidiol, mitigated side effects and improved sleep, suggesting a potential alternative treatment for ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical Cannabis for Adult Attention Deficit Hyperactivity Disorder: Sociological Patient Case Report of Cannabinoid Therapeutics in Finland. Hupli, AMM.[2021]

In a case report involving three young men with ADHD, integrating cannabis into their treatment led to significant subjective improvements in symptoms and quality of life, supported by validated rating scales showing reductions in depression, anxiety, and inattention scores after starting cannabis.

While the patients experienced mild adverse effects like short-term memory issues and dry mouth, blood tests confirmed that cannabinoids were not present before treatment, indicating that cannabis may have played a beneficial role in their overall management of ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis for the Treatment of Attention Deficit Hyperactivity Disorder: A Report of 3 Cases. Mansell, H., Quinn, D., Kelly, LE., et al.[2022]

In a study involving 40 children with drug-resistant epilepsy, cannabidiol was found to have a manageable safety profile, with the most common side effect being somnolence, which resolved in most cases.

Caregivers reported subjective improvements in their children's overall health, although the study's open-label design means that it's unclear if these benefits were directly due to cannabidiol treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol for treating drug-resistant epilepsy in children: the New South Wales experience. Chen, KA., Farrar, M., Cardamone, M., et al.[2020]

This pilot study involving 8 children aged 8-16 with intellectual disability and severe behavioral problems showed that a randomized placebo-controlled trial of cannabidiol is feasible and well-accepted by families, with no serious adverse events reported.

There was an observed efficacy signal favoring cannabidiol in reducing severe behavioral problems, indicating potential therapeutic benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomised placebo-controlled trial of cannabidiol to reduce severe behavioural problems in children and adolescents with intellectual disability. Efron, D., Freeman, JL., Cranswick, N., et al.[2021]

Cannabidiol (CBD) has been associated with significant adverse events, particularly 'weight decreased', 'hypophagia', and 'insomnia', based on a disproportionality analysis of reports from the VigiBase® database involving various patients.

The interaction of CBD with the serotonin 5-HT1A receptor may explain the occurrence of insomnia, highlighting the need for careful monitoring of these side effects in patients using CBD for conditions like Lennox-Gastaut syndrome and Dravet syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological Evaluation of Signals of Disproportionality Reporting Related to Adverse Reactions to Antiepileptic Cannabidiol in VigiBase. Calapai, F., Mannucci, C., McQuain, L., et al.[2023]

Nearly 50% of CBD users experienced adverse drug events (ADEs), with common issues including elevated liver enzymes, sedation, and sleep disturbances, indicating a significant safety concern.

CBD has a high potential for drug-drug interactions (DDIs) due to its effects on drug metabolism, particularly with enzymes like CYP3A4 and CYP2C19, suggesting that careful monitoring and dose adjustments may be necessary for patients on multiple medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Adverse Drug Events and Drug-Drug Interactions with Medical and Consumer Cannabidiol (CBD) Use. Brown, JD., Winterstein, AG.[2020]

This systematic review analyzed nine randomized controlled trials (RCTs) on the use of cannabidiol (CBD) for neurodevelopmental disorders, revealing inconsistent evidence for its efficacy, which makes it difficult to recommend for clinical use.

While some studies suggest potential benefits of CBD for conditions like ADHD and autism, the overall variability in study design and outcomes indicates that more rigorous research is needed to establish its safety and effectiveness as a treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of cannabidiol trials in neurodevelopmental disorders. Parrella, NF., Hill, AT., Enticott, PG., et al.[2023]

Cannabigerol (CBG), a compound derived from Cannabis sativa L., shows promising therapeutic potential due to its wide range of biological activities, including anti-inflammatory, antibacterial, and neuromodulatory effects.

CBG's ability to interact with G-protein-coupled receptors suggests it could be useful in treating various diseases that require complex pharmacotherapy, making it a candidate for future therapeutic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Origin and Biomedical Relevance of Cannabigerol. Jastrząb, A., Jarocka-Karpowicz, I., Skrzydlewska, E.[2022]

In a study involving rats and shrews, cannabidiol (CBD) effectively reduced nausea and vomiting, but this effect was reversed when pre-treated with cannabigerol (CBG), indicating a potential antagonistic interaction between the two cannabinoids at the 5-HT(1A) receptor.

The findings suggest that while CBD has anti-nausea properties, the presence of CBG can negate these benefits, highlighting the importance of understanding cannabinoid interactions for therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interaction between non-psychotropic cannabinoids in marihuana: effect of cannabigerol (CBG) on the anti-nausea or anti-emetic effects of cannabidiol (CBD) in rats and shrews. Rock, EM., Goodwin, JM., Limebeer, CL., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Survey of Patients Employing Cannabigerol-Predominant Cannabis Preparations: Perceived Medical Effects, Adverse Events, and Withdrawal Symptoms. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The Pharmacological Case for Cannabigerol. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Pharmacological Aspects and Biological Effects of Cannabigerol and Its Synthetic Derivatives. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Medical Cannabis for Adult Attention Deficit Hyperactivity Disorder: Sociological Patient Case Report of Cannabinoid Therapeutics in Finland. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Cannabis for the Treatment of Attention Deficit Hyperactivity Disorder: A Report of 3 Cases. [2022]

6. Australia pubmed.ncbi.nlm.nih.gov

Cannabidiol for treating drug-resistant epilepsy in children: the New South Wales experience. [2020]

7. England pubmed.ncbi.nlm.nih.gov

A pilot randomised placebo-controlled trial of cannabidiol to reduce severe behavioural problems in children and adolescents with intellectual disability. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacological Evaluation of Signals of Disproportionality Reporting Related to Adverse Reactions to Antiepileptic Cannabidiol in VigiBase. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Potential Adverse Drug Events and Drug-Drug Interactions with Medical and Consumer Cannabidiol (CBD) Use. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

A systematic review of cannabidiol trials in neurodevelopmental disorders. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

The Origin and Biomedical Relevance of Cannabigerol. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

Interaction between non-psychotropic cannabinoids in marihuana: effect of cannabigerol (CBG) on the anti-nausea or anti-emetic effects of cannabidiol (CBD) in rats and shrews. [2021]