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New treatment option for Attention-Deficit/Hyperactivity Disorder
Official title The Effects of Cannabigerol on Attention-Deficit/Hyperactivity Disorder
ClinicalTrials.gov ID: NCT06115603
What this study is testing
What is Cannabigerol?
Cannabigerol is an investigational medicine, given as an once-daily, being studied as a potential treatment for attention-deficit/hyperactivity disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Between 18 and 55-years-old.
- BMI between 18 and 35 kg/m2.
- Score a 4 or above on the Adult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist Part A.
- Meet diagnostic criteria for ADHD with a current severity rating of at least mild as defined by the DIAMOND.
- Are not pregnant or currently breastfeeding.
See the full eligibility criteria
- Between 18 and 55-years-old.
- BMI between 18 and 35 kg/m2.
- Score a 4 or above on the Adult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist Part A.
- Meet diagnostic criteria for ADHD with a current severity rating of at least mild as defined by the DIAMOND.
- Are not pregnant or currently breastfeeding.
- Have no history of significant allergic condition, hypersensitivity, or allergic reactions to cannabis, cannabinoid medications, hemp products, medium chain triglyceride oil, or peppermint.
- Have not used CBG or any other cannabinoid products in the past 30 days.
- Willing to abstain from using cannabis or any THC-containing product for the duration of the study.
- Have never used a synthetic cannabinoid or cannabinoid analogue (e.g., dronabinol, nabilone), or a synthetic cannabinoid receptor agonist (e.g., spice, k2).
- 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.
- Willing to maintain a stable treatment regimen (i.e., no change in current medication use) for the duration of the study.
- Not currently taking a prescription medication for ADHD and have not been prescribed a medication for ADHD in the past six months.
- Not currently having thoughts of committing suicide
- Does not meet criteria for current severe major depressive disorder or a substance use disorder.
- Have not been diagnosed with bipolar disorder or psychosis.
- 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).
- Do not have history of diagnosis related to liver function and/or significantly impaired liver function (e.g., cirrhosis of the liver, hepatitis).
- 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.
- Have access to a ride to the University of Arkansas campus for research appointments.
- Willing to comply with current university mandates as they pertain to COVID-19 protocols (e.g., mask wearing).
- Do not have any serious or unstable physical health conditions including neurological or renal illness.
- Do not have any current or historical cardiovascular conditions, including hypotension, bradycardia, or heart block.
- No atrial fibrillation, bradycardia, or tachycardia detected via mobile electrocardiogram during the in-laboratory visit.
- No recent illicit drug use other than cannabis, or alcohol use in the 12 hours preceding the in-laboratory visit.
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Fayetteville, Arkansas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fayetteville, Arkansas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.