The Effects of Cannabigerol on Attention-Deficit/Hyperactivity Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUniversity of Arkansas, Fayetteville
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Cannabigerol
Drug1 mL of 80mg Cannabigerol once during experimental session
Placebo
Other intervention1 mL of placebo once during experimental session
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: CannabigerolActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sustained Attention to Response Task
A computerized task that measures response inhibition.
Time frame
75 minutes post CBG/placebo administration2
Trail Making Test-Parts A and B (TMT-A&B)
A paper-and-pencil task that measures
Time frame
75 minutes post CBG/placebo administration3
Digit Symbol Substitution Test (DSST)
A paper-and-pencil task that measures attention/processing speed.
Time frame
75 minutes post CBG/placebo administration4
Rey Auditory Verbal Learning Test (AVLT)
A paper-and-pencil/verbal test that measures verbal memory.
Time frame
75 minutes post CBG/placebo administrationSecondary outcomes
1
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.
Time frame
Baseline, 45 minutes post CBG/placebo administration, 75 minutes post CBG/placebo administration2
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.
Time frame
Pre CBG/placebo administration, 75 minutes post CBG/placebo administration3
Brief Irritability Test
Self-report measure of irritability. Scores range from 5-30, with higher scores representing greater irritability.
Time frame
Pre CBG/placebo administration, 75 minutes post CBG/placebo administration4
Numeric Rating Scale (pain)
Self-report measure of subjective level of pain. Scores range from 0-10, with higher scores representing greater pain.
Time frame
Pre CBG/placebo administration, 75 minutes post CBG/placebo administrationSponsors and contacts
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Source ClinicalTrials.gov