CBG and Attention: A Double-Blind, Randomized, Placebo-Controlled Trial Examining the Effects of Cannabigerol on Indicators of Attention-Deficit/Hyperactivity Disorder
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Sustained Attention to Response Task
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants and researchers interacting with participants will be blind to condition. An unblinded researcher team will randomize and label all pipettes containing CBG or placebo prior to each participants' session. Participants will receive individual, 1 mL pipettes containing CBG and placebo (pipettes are indistinguishable).
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 18 and 55-years-old.
- •BMI between 18 and 35 kg/m
- •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:
- •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)
排除标准
- 未提供
研究组 & 干预措施
Cannabigerol
1mL of 80mg of Cannabigerol. Cannabigerol is a safe, legal, non-high-inducing cannabinoid obtained from the cannabis plant.
干预措施: Cannabigerol (Drug)
Placebo
1mL of Placebo. Placebo is made in the form of MCT oil.
干预措施: Placebo (Other)
结局指标
主要结局
Sustained Attention to Response Task
时间窗: 75 minutes post CBG/placebo administration
A computerized task that measures response inhibition.
Trail Making Test-Parts A and B (TMT-A&B)
时间窗: 75 minutes post CBG/placebo administration
A paper-and-pencil task that measures
Digit Symbol Substitution Test (DSST)
时间窗: 75 minutes post CBG/placebo administration
A paper-and-pencil task that measures attention/processing speed.
Rey Auditory Verbal Learning Test (AVLT)
时间窗: 75 minutes post CBG/placebo administration
A paper-and-pencil/verbal test that measures verbal memory.
Iowa Gambling Task (IGT)
时间窗: 75 minutes post CBG/placebo administration
A computerized task that measures decision making (an indicator of impulsivity/hyperactivity).
次要结局
- Positive and Negative Affect Scale-Expanded Version(Baseline, 45 minutes post CBG/placebo administration, 75 minutes post CBG/placebo administration)
- Karolinska Sleepiness Scale(Pre CBG/placebo administration, 75 minutes post CBG/placebo administration)
- Brief Irritability Test(Pre CBG/placebo administration, 75 minutes post CBG/placebo administration)
- Numeric Rating Scale (pain)(Pre CBG/placebo administration, 75 minutes post CBG/placebo administration)
- State-Trait Anxiety Inventory (State Version)(Pre CBG/placebo administration, 75 minutes post CBG/placebo administration)
- Visual Analog Scales(75 minutes post CBG/placebo administration)
- Global Impression of Change(75 minutes post CBG/placebo administration)
研究者
Ellen Leen-Feldner
Professor
University of Arkansas, Fayetteville