The Effects of Cannabigerol on Attention-Deficit/Hyperactivity Disorder

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Cannabigerol
  1 mL of 80mg Cannabigerol once during experimental session
• Другое Placebo
  1 mL of placebo once during experimental session

Первичные конечные точки

• Sustained Attention to Response Task [Срок оценки: 75 minutes post CBG/placebo administration]
• Trail Making Test-Parts A and B (TMT-A&B) [Срок оценки: 75 minutes post CBG/placebo administration]
• Digit Symbol Substitution Test (DSST) [Срок оценки: 75 minutes post CBG/placebo administration]
• Rey Auditory Verbal Learning Test (AVLT) [Срок оценки: 75 minutes post CBG/placebo administration]
• Iowa Gambling Task (IGT) [Срок оценки: 75 minutes post CBG/placebo administration]

Вторичные конечные точки (7)

• Positive and Negative Affect Scale-Expanded Version [Срок оценки: Baseline, 45 minutes post CBG/placebo administration, 75 minutes post CBG/placebo administration]
• Karolinska Sleepiness Scale [Срок оценки: Pre CBG/placebo administration, 75 minutes post CBG/placebo administration]
• Brief Irritability Test [Срок оценки: Pre CBG/placebo administration, 75 minutes post CBG/placebo administration]
• Numeric Rating Scale (pain) [Срок оценки: Pre CBG/placebo administration, 75 minutes post CBG/placebo administration]
• State-Trait Anxiety Inventory (State Version) [Срок оценки: Pre CBG/placebo administration, 75 minutes post CBG/placebo administration]
• Visual Analog Scales [Срок оценки: 75 minutes post CBG/placebo administration]
• Global Impression of Change [Срок оценки: 75 minutes post CBG/placebo administration]

Критерии участия

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Arkansas — Fayetteville

Идентификаторы

NCT: NCT06115603 · 2309494774

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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