Attention-Deficit/Hyperactivity DisorderPhase 2CBGNCT06115603
The Effects of Cannabigerol on Attention-Deficit/Hyperactivity Disorder
A Phase 2 study testing Cannabigerol in people with Attention-Deficit/Hyperactivity Disorder, run by University of Arkansas, Fayetteville at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder
- What is being tested?
- Cannabigerol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2024to 30 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas
Fayetteville, Arkansas, 72703
About this study
Official title: CBG and Attention: A Double-Blind, Randomized, Placebo-Controlled Trial Examining the Effects of Cannabigerol on Indicators of Attention-Deficit/Hyperactivity Disorder
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.
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Being tested
- Cannabigerol, Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabigerolDrug
1 mL of 80mg Cannabigerol once during experimental session
PlaceboOther
1 mL of placebo once during experimental session
| Study group | Role | What they receive |
|---|---|---|
| Cannabigerol | Active comparator | 1mL of 80mg of Cannabigerol. Cannabigerol is a safe, legal, non-high-inducing cannabinoid obtained from the cannabis plant. Receives: Drug: Cannabigerol |
| Placebo | Placebo comparator | 1mL of Placebo. Placebo is made in the form of MCT oil. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Attention to Response Task
A computerized task that measures response inhibition.
Measured: 75 minutes post CBG/placebo administration
Trail Making Test-Parts A and B (TMT-A&B)
A paper-and-pencil task that measures
Measured: 75 minutes post CBG/placebo administration
Digit Symbol Substitution Test (DSST)
A paper-and-pencil task that measures attention/processing speed.
Measured: 75 minutes post CBG/placebo administration
Rey Auditory Verbal Learning Test (AVLT)
A paper-and-pencil/verbal test that measures verbal memory.
Measured: 75 minutes post CBG/placebo administration
Iowa Gambling Task (IGT)
A computerized task that measures decision making (an indicator of impulsivity/hyperactivity).
Measured: 75 minutes post CBG/placebo administration
Secondary outcomes (7)
Positive and Negative Affect Scale-Expanded Version
Self-report measure of positive and negative affect. Scores range from 30-150 on each of the two types of affects, with higher scores representing greater affect.
Measured: Baseline, 45 minutes post CBG/placebo administration, 75 minutes post CBG/placebo administration
Karolinska Sleepiness Scale
Self-report measure of subjective level of sleepiness at a particular time during the day. Scores range from 1-10, with higher scores representing greater sleepiness.
Measured: Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
Brief Irritability Test
Self-report measure of irritability. Scores range from 5-30, with higher scores representing greater irritability.
Measured: Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
Numeric Rating Scale (pain)
Self-report measure of subjective level of pain. Scores range from 0-10, with higher scores representing greater pain.
Measured: Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
State-Trait Anxiety Inventory (State Version)
Self-report measure of state anxiety. Scores range from 20 to 80 with higher scores indicating greater anxiety.
Measured: Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
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.
Measured: 75 minutes post CBG/placebo administration
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.
Measured: 75 minutes post CBG/placebo administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start14 Dec 2024
- Primary completion15 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas, Fayetteville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen Leen-Feldner, University of Arkansas, Fayetteville
- Investigators
- Ellen W Leen-Feldner, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115603
- Sponsor's protocol ID
- 2309494774
- Acronym
- CBG
- Status last verified
- Nov 2026
- First submitted
- 10 Oct 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified, individual participant data (including data dictionaries) that underlie results reported in each published report will be shared (text, tables, figures, appendices)
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBG and Attention: A Double-Blind, Randomized, Placebo-Controlled Trial Examining the Effects of Cannabigerol on Indicators of Attention-Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT06115603
- Acronym / sponsor ID
- CBG / 2309494774
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of Arkansas, FayettevilleUniversity, hospital or other
- Study start
- 14 Dec 2024 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabigerol | Active comparator | Drug: Cannabigerol1mL of 80mg of Cannabigerol. Cannabigerol is a safe, legal, non-high-inducing cannabinoid obtained from the cannabis plant. |
| Placebo | Placebo comparator | Other: Placebo1mL of Placebo. Placebo is made in the form of MCT oil. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabigerol1 mL of 80mg Cannabigerol once during experimental session | Drug | Cannabigerol |
| Placebo1 mL of placebo once during experimental session | Other | Placebo |
Primary outcome
Sustained Attention to Response Task
Time frame: 75 minutes post CBG/placebo administration
A computerized task that measures response inhibition.
Trail Making Test-Parts A and B (TMT-A&B)
Time frame: 75 minutes post CBG/placebo administration
A paper-and-pencil task that measures
Digit Symbol Substitution Test (DSST)
Time frame: 75 minutes post CBG/placebo administration
A paper-and-pencil task that measures attention/processing speed.
Rey Auditory Verbal Learning Test (AVLT)
Time frame: 75 minutes post CBG/placebo administration
A paper-and-pencil/verbal test that measures verbal memory.
Iowa Gambling Task (IGT)
Time frame: 75 minutes post CBG/placebo administration
A computerized task that measures decision making (an indicator of impulsivity/hyperactivity).
7 secondary outcomes
Positive and Negative Affect Scale-Expanded Version
Time frame: Baseline, 45 minutes post CBG/placebo administration, 75 minutes post CBG/placebo administration
Karolinska Sleepiness Scale
Time frame: Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
Brief Irritability Test
Time frame: Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
Numeric Rating Scale (pain)
Time frame: Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
State-Trait Anxiety Inventory (State Version)
Time frame: Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
Visual Analog Scales
Time frame: 75 minutes post CBG/placebo administration
Global Impression of Change
Time frame: 75 minutes post CBG/placebo administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. De-identified, individual participant data (including data dictionaries) that underlie results reported in each published report will be shared (text, tables, figures, appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen W Leen-Feldner, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabigerol in people with Attention-Deficit/Hyperactivity Disorder, run by University of Arkansas, Fayetteville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Attention to Response Task (time frame: 75 minutes post CBG/placebo administration). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.