The Effects of Cannabigerol on Attention-Deficit/Hyperactivity Disorder

Attention-Deficit/Hyperactivity Disorder Clinical Trial

— CBG  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06115603
• Other study ID #: 2309494774
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 2024
• Est. completion date: October 2024

Study information

• Verified date: October 2023
• Source: University of Arkansas, Fayetteville
• Contact: Ellen W Leen-Feldner, PhD
• Phone: 4795754256
• Email: eleenfe[@]uark.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit/Hyperactivity Disorder
• Hyperkinesis

Intervention

Dietary Supplement:
• Cannabigerol
80mg (1 mL) of Cannabigerol daily for 14 days
• Placebo
Placebo (1 mL) daily for 14 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas, Fayetteville

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adult ADHD Self-Report Scale	Self-reported ADHD symptoms. Scores range from 0-18, with higher scores representing greater severity of symptoms.	Baseline, weekly throughout study participation for ~5 weeks
Primary	Safety/tolerability of CBG/Placebo	Participants will rate indications of safety/tolerability (e.g., anxiety, good drug effect, trouble remembering)	Daily, throughout administration phases (4 weeks total)
Secondary	Barrett Impulsiveness Scale-11	Self-report measure of impulsivity. Scores range from 30-120, with higher scores representing greater severity.	Baseline, weekly throughout study participation for ~5 weeks
Secondary	Anxiety Sensitivity Index-3	Self-report measure of anxiety sensitivity. Scores range from 0-72, with higher scores representing greater anxiety sensitivity.	Baseline, weekly throughout study participation for ~5 weeks
Secondary	Brief Irritability Test	Self-report measure of irritability. Scores range from 5-30, with higher scores representing greater irritability.	Baseline, weekly throughout study participation for ~5 weeks
Secondary	Caffeine Consumption Questionnaire-Revised	Self-report measure of caffeine consumption. This scale ranges from 0 (no caffeine consumption) to no maximum value (caffeine consumption in mg is continuous)	Baseline, weekly throughout study participation for ~5 weeks
Secondary	Depression Anxiety Stress Scales	Self-report measure of depression, anxiety, and stress. Each subscale ranges from 0-42, with higher scores representing greater severity of symptoms.	Baseline, weekly throughout study participation for ~5 weeks
Secondary	PROMIS-Sleep Disturbance Scale	Self-report measure of sleep disturbance. Scores range from 8 to 40 with higher scores indicating greater severity of sleep disturbance	Baseline, weekly throughout study participation for ~5 weeks
Secondary	PROMIS-Sleep Related Impairment Scale	Self-report measure of sleep-related impairment. Scores range from 8 to 40 with higher indicating greater levels of sleep related impairment.	Baseline, weekly throughout study participation for ~5 weeks
Secondary	Perceived Stress Scale-10	Self-report measure of perceived stress. This scale ranges from 0 to 40 with higher scores indicating higher perceived stress.	Baseline, weekly throughout study participation for ~5 weeks
Secondary	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.	Baseline, daily and weekly throughout study participation for ~5 weeks
Secondary	Brief Measure of Worry Severity	Self-report of worry severity. This scale ranges from 0 to 24 with higher scores indicating higher worry.	Baseline, weekly throughout study participation for ~5 weeks
Secondary	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.	Baseline, weekly throughout study participation for ~5 weeks
Secondary	Timeline Follow back-Alcohol	Self-report of alcohol use. This scale ranges from 0 (no caffeine consumption) to no maximum value (# of drinks is continuous)	Baseline, weekly throughout study participation for ~5 weeks
Secondary	Web-based executive function questionnaire - short form	Self-report of executive function. This scale ranges from 6 to 24 with higher scores indicating greater problems with executive control.	Baseline, weekly throughout study participation for ~5 weeks