Psychological and Physiological Effects of Cannabigerol (CBG)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Anxiety
研究概览
简要总结
The purpose of this study is to examine the acute effects of cannabigerol (CBG) on various psychological (e.g., anxiety, stress, mood, memory, impairment, intoxication, side effects) and physiological (blood pressure, cortisol, heart rate variability, electrodermal activity, pain tolerance, temperature) outcomes. Further, potential side effects of CBG (sleepiness/fatigue, dry mouth/eyes, increased appetite, and dizziness nausea) will be assessed. As such, the study is focused on better understanding some of the potentially beneficial and detrimental effects of CBG on humans.
详细描述
Recruitment: Healthy adult participants (aged 21+) will be recruited from the community via advertisements posted on campus, in businesses (including cannabis dispensaries), and on social media. Prospective participants will complete a brief online Qualtrics survey to determine eligibility. Specifically, to be eligible participants will need to be 21+ years of age, speak fluent English, be literate, be free of serious psychiatric disorders (psychotic disorders, bipolar disorders), neurological disorders (head injuries, brain tumors, Parkinson's disease), diabetes, low blood pressure, pregnancy, or breastfeeding. Participants must not report recent use (past 2 months) of illicit substances or dietary restrictions that would prevent them from eating the standardized breakfast (muffin, yogurt, juice/milk).
Eligible participants will be contacted via email and will be asked to schedule two testing sessions (1 week apart) that will begin between 8:00 and 9:30 am. They will be asked to abstain from CBG use for 1 week before the first testing session and to fast and abstain from cannabis use from midnight the night before each session (8 - 9.5 hours). The PI will use a random number generator to randomly assign each participant to ingest either the CBG tincture (50 mg) or placebo tincture orally in the first testing session and the opposite tincture in the second testing session.
Consent and Eligibility Confirmation. Participants will meet a graduate research assistant in The Health & Cognition (THC) lab in the Department of Psychology at Washington State University. After obtaining written informed consent participants will be asked when they last used CBG (if applicable), when they last used cannabis (if applicable), and when they last ate. Participants who report using CBG within the past week or cannabis after midnight the night prior or eating that day will be rescheduled and will be reminded that they must abstain from CBG for one week as well as from any cannabis use and food consumption on the day of the testing session. Participants who adhered to the abstinence requirements will be asked to complete a 12-panel urine drug test to ensure they test negative for illicit drugs. Participants who test positive for illicit drugs (other than THC) are not eligible and will not be permitted to complete the study. Participants who pass the drug test will have their blood pressure measured. Those with blood pressure lower than 90/60 mm Hg (indicating hypotension) will be excused.
T0 (Baseline) Assessments. Participants will be asked to wear a medical-grade wristband (Embrace device) that will continuously monitor their heart rate, electrodermal activity, and temperature. They will also be asked to provide a small saliva sample by rinsing their mouth for 1 minute, chewing on a Salivette for 1 minute, and then spitting the saturated Salivette in a sterile tube. Next, they will then complete a baseline assessment of motor/cognitive impairment using the DRiving Under the Influence of Drugs (DRUID) app.
Next, they will provide baseline ratings of their anxiety, stress, and mood using 0 to 10 visual analog rating scales. Participants will also rate their level of intoxication (to ensure it is 0) and provide baseline ratings of potential side effects (dry mouth, dry eyes, sleepiness, increased appetite, nausea, heart palpitations/racing heart, dizziness) using 0 (not at all severe) to 10 (extremely severe) visual analog scales. They will also be asked if they are experiencing any other physiological or psychological symptoms in an open-ended manner and to rate each on 0 (not at all) to 10 (severe) rating scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The research assistants who administer the protocol will be masked.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21+ years of age Fluent in English
排除标准
- •Illiterate Serious psychiatric disorders (i.e., psychotic disorders, bipolar disorders) Intellectual disability Chronic neurological disorders (e.g., head injuries, brain tumors, Parkinson's disease) Diabetes Low blood pressure Pregnant or breastfeeding Recent illicit drug use (past 2 months) - does not include cannabis Dietary restrictions preventing them from eating muffin, yogurt, milk/juice
研究组 & 干预措施
Placebo Arm
Participants in this arm will receive a placebo
干预措施: Placebo Intervention (Other)
CBG Arm
Participants in this arm will receive CBG
干预措施: CBG Intervention (Dietary Supplement)
结局指标
主要结局
Anxiety
时间窗: Anxiety ratings will occur within a 2.5 hour time frame for each session with sessions scheduled approximately one week apart
Anxiety will be assessed along a 0 to 10 rating scale at baseline (T0), \~40 minutes after ingesting placebo or CBG (T1), after the stress test (T2), and after the memory tests (T3). Change scores from baseline to each time point will be examined.
Stress
时间窗: Stress ratings will occur within a 2.5 hour time frame for each session with sessions scheduled approximately one week apart
Stress will be assessed along a 0 to 10 rating scale at baseline (T0), \~40 minutes after ingesting placebo or CBG (T1), after the stress test (T2), and after the memory tests (T3). Change scores from baseline to each time point will be examined.
Mood
时间窗: Mood ratings will occur within a 2.5 hour time frame for each session with sessions scheduled approximately one week apart
Mood will be assessed along a 0 to 10 rating scale at baseline (T0), \~40 minutes after ingesting placebo or CBG (T1), after the stress test (T2), and after the memory tests (T3). Change scores from baseline to each time point will be examined.
Salivary Cortisol
时间窗: Saliva samples will be collected within the 2.5 hour time frame for each session with sessions scheduled approximately one week apart
Salivary Cortisol will be collected using Salivettes at baseline (T0), \~40 minutes after ingesting placebo or CBG (T1), after the stress test (T2), and after memory the memory tests (T3). Change scores from baseline to each time point will be examined.
Electrodermal Activity
时间窗: Electrodermal Activity will be measured continuously for the duration of the 2.5 hour session for each session with sessions scheduled approximately one week apart
Electrodermal Activity will be assessed continuously using an Embrace wristband device from baseline to the end of the study. Primary points of interest include baseline (T0), after ingesting placebo or CBG (T1), after the stress test (T2), and after the memory tests (T3).
Heart Rate/Heart Rate Variability
时间窗: Heart Rate/Heart Rate Variability will be assessed continuously for the duration of the 2.5 hour session with sessions scheduled approximately one week apart
Heart rate/heart rate variability will be assessed continuously using an Embrace wristband device from baseline to the end of the study. Primary points of interest include baseline (T0), after ingesting placebo or CBG (T1), after the stress test (T2), and after the memory tests (T3).
Blood Pressure
时间窗: Blood Pressure will be obtained multiple times throughout the 2.5 hour session for each session with sessions scheduled approximately one week apart
Blood Pressure will be assessed at baseline (T0), \~40 minutes after ingesting placebo or CBG (T1), after the stress test (T2), and after the memory tests (T3). Change scores from baseline to each time point will be examined.
Pain Tolerance
时间窗: Pain tolerance will be assessed within a 2.5 hour time frame for each session with sessions scheduled approximately one week apart
Pain tolerance will be assessed by computing the duration of time they keep their hand in the cold pressor on each of the three cold pressor trials.
Verbal Memory
时间窗: Participants will complete this test within a 2.5 hour time frame for each session with sessions scheduled approximately one week apart
Participants will complete the California Verbal Learning Test
Short-Term/Working Memory
时间窗: Participants will complete this test within a 2.5 hour time frame for each session with sessions scheduled approximately one week apart
Participants will complete the Digit Span Forwards and Digit Span Backwards Tests
False Memory
时间窗: Participants will complete this test within a 2.5 hour time frame for each session with sessions scheduled approximately one week apart
Participants will complete the Deese-Roediger-McDermott paradigm.
次要结局
- Impairment(Participants will complete the DRUID app within the 2.5 hour time frame for each session with sessions scheduled approximately one week apart)
- Subjective Drug Effects(Subjective drug effect ratings will occur within a 2.5 hour time frame for each session with sessions scheduled approximately one week apart)
- Side Effects(Side effect ratings will occur within a 2.5 hour time frame for each session with sessions scheduled approximately one week apart)
研究者
Carrie Cuttler
Associate Professor
Washington State University