ClinicalTrials.Veeva

Menu

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

U

University of Arkansas, Fayetteville

Status and phase

Not yet enrolling
Phase 2

Conditions

Attention-Deficit/Hyperactivity Disorder

Treatments

Dietary Supplement: Cannabigerol
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT06115603
2309494774

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the effects of Cannabigerol (CBG) on symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in a sample of participants with ADHD. The main question it aims to answer is: Does CBG reduce ADHD symptoms relative to placebo? Participants will complete two weeks of product administration for each condition (placebo or 80mg CBG daily), separated by a one-week washout period. Daily and weekly surveys will be administered to monitor effects.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility Criteria

  1. Between 18 and 55-years-old.

  2. BMI between 18 and 35 kg/m2.

  3. Are diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) via self-report.

  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 month.

  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 in psychotherapy.

  14. Not currently having thoughts of committing suicide.

  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.

  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. Not currently prescribed or taking the following medications:

    1. Warfarin
    2. Clobazam
    3. Valproic acid
    4. Phenobarbital
    5. Mechanistic Target of Rapamycin [mTOR] Inhibitors
    6. Oral tacrolimus
    7. St. John's wort
    8. Epidiolex
    9. Escitalopram
  22. Not currently prescribed any cardiovascular medications.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

30 participants in 2 patient groups, including a placebo group

Cannabigerol
Active Comparator group
Description:
80mg of Cannabigerol daily for 14 days. Cannabigerol is a safe, legal, non-high-inducing cannabinoid obtained from the cannabis plant.
Treatment:
Dietary Supplement: Cannabigerol
Placebo
Placebo Comparator group
Description:
80mg of placebo daily for 14 days Placebo is made in the form of MCT oil.
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

0

Loading...

Central trial contact

Ellen W Leen-Feldner, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems