CBG: The Effects of Cannabigerol on Attention-Deficit/Hyperactivity Disorder
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Cannabigerol 80mg of Cannabigerol daily for 14 days. Cannabigerol is a safe, legal, non-high-inducing cannabinoid obtained from the cannabis plant. |
Dietary Supplement: Cannabigerol
80mg (1 mL) of Cannabigerol daily for 14 days
|
| Placebo Comparator: Placebo 80mg of placebo daily for 14 days Placebo is made in the form of MCT oil. |
Dietary Supplement: Placebo
Placebo (1 mL) daily for 14 days
|
Outcome Measures
Primary Outcome Measures
- Adult ADHD Self-Report Scale [Baseline, weekly throughout study participation for ~5 weeks]
Self-reported ADHD symptoms. Scores range from 0-18, with higher scores representing greater severity of symptoms.
- Safety/tolerability of CBG/Placebo [Daily, throughout administration phases (4 weeks total)]
Participants will rate indications of safety/tolerability (e.g., anxiety, good drug effect, trouble remembering)
Secondary Outcome Measures
- Barrett Impulsiveness Scale-11 [Baseline, weekly throughout study participation for ~5 weeks]
Self-report measure of impulsivity. Scores range from 30-120, with higher scores representing greater severity.
- Anxiety Sensitivity Index-3 [Baseline, weekly throughout study participation for ~5 weeks]
Self-report measure of anxiety sensitivity. Scores range from 0-72, with higher scores representing greater anxiety sensitivity.
- Brief Irritability Test [Baseline, weekly throughout study participation for ~5 weeks]
Self-report measure of irritability. Scores range from 5-30, with higher scores representing greater irritability.
- Caffeine Consumption Questionnaire-Revised [Baseline, weekly throughout study participation for ~5 weeks]
Self-report measure of caffeine consumption. This scale ranges from 0 (no caffeine consumption) to no maximum value (caffeine consumption in mg is continuous)
- Depression Anxiety Stress Scales [Baseline, weekly throughout study participation for ~5 weeks]
Self-report measure of depression, anxiety, and stress. Each subscale ranges from 0-42, with higher scores representing greater severity of symptoms.
- PROMIS-Sleep Disturbance Scale [Baseline, weekly throughout study participation for ~5 weeks]
Self-report measure of sleep disturbance. Scores range from 8 to 40 with higher scores indicating greater severity of sleep disturbance
- PROMIS-Sleep Related Impairment Scale [Baseline, weekly throughout study participation for ~5 weeks]
Self-report measure of sleep-related impairment. Scores range from 8 to 40 with higher indicating greater levels of sleep related impairment.
- Perceived Stress Scale-10 [Baseline, weekly throughout study participation for ~5 weeks]
Self-report measure of perceived stress. This scale ranges from 0 to 40 with higher scores indicating higher perceived stress.
- Visual Analog Scales [Baseline, daily and weekly throughout study participation for ~5 weeks]
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.
- Brief Measure of Worry Severity [Baseline, weekly throughout study participation for ~5 weeks]
Self-report of worry severity. This scale ranges from 0 to 24 with higher scores indicating higher worry.
- Global Impression of Change [Baseline, weekly throughout study participation for ~5 weeks]
Self-report measure of perceived change in ADHD symptoms. This scale ranges from 1 to 7 with higher scores indicating greater improvements.
- Timeline Follow back-Alcohol [Baseline, weekly throughout study participation for ~5 weeks]
Self-report of alcohol use. This scale ranges from 0 (no caffeine consumption) to no maximum value (# of drinks is continuous)
- Web-based executive function questionnaire - short form [Baseline, weekly throughout study participation for ~5 weeks]
Self-report of executive function. This scale ranges from 6 to 24 with higher scores indicating greater problems with executive control.
Eligibility Criteria
Criteria
Eligibility Criteria
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Between 18 and 55-years-old.
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BMI between 18 and 35 kg/m2.
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Are diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) via self-report.
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Meet diagnostic criteria for ADHD with a current severity rating of at least mild as defined by the DIAMOND.
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Are not pregnant or currently breastfeeding.
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Have no history of significant allergic condition, hypersensitivity, or allergic reactions to cannabis, cannabinoid medications, hemp products, medium chain triglyceride oil, or peppermint.
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Have not used CBG or any other cannabinoid products in the past month.
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Willing to abstain from using cannabis or any THC-containing product for the duration of the study.
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Have never used a synthetic cannabinoid or cannabinoid analogue (e.g., dronabinol, nabilone), or a synthetic cannabinoid receptor agonist (e.g., spice, k2).
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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.
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Willing to maintain a stable treatment regimen (i.e., no change in current medication use) for the duration of the study.
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Not currently taking a prescription medication for ADHD and have not been prescribed a medication for ADHD in the past six months.
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Not currently in psychotherapy.
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Not currently having thoughts of committing suicide.
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Have not been diagnosed with bipolar disorder or psychosis.
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Do not have an acute illness, such as a respiratory infection or other illness that would interfere with study participation.
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Do not have history of diagnosis related to liver function and/or significantly impaired liver function (e.g., cirrhosis of the liver, hepatitis).
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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.
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Have access to a ride to the University of Arkansas campus for research appointments.
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Willing to comply with current university mandates as they pertain to COVID-19 protocols (e.g., mask wearing).
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Not currently prescribed or taking the following medications:
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Warfarin
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Clobazam
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Valproic acid
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Phenobarbital
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Mechanistic Target of Rapamycin [mTOR] Inhibitors
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Oral tacrolimus
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St. John's wort
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Epidiolex
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Escitalopram
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Not currently prescribed any cardiovascular medications.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Arkansas, Fayetteville
Investigators
- Principal Investigator: Ellen W Leen-Feldner, PhD, University of Arkansas
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2309494774