Developing Predictive Models to Distinguish Alcohol Use, Cannabis Use and Co-use: An Exploration of Electroencephalography (EEG) Metrics and Traditional Intoxication Measures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Electroencephalography (EEG) Objective Cognitive Function Measures--Amplitude (microvolts)
研究概览
简要总结
This is a randomized, parallel-group study designed to explore the differences between cannabis intoxication, alcohol intoxication and co-intoxication involving both alcohol and cannabis, utilizing electroencephalography (EEG) as well as more traditional intoxication measures such as breath alcohol concentration and balance metrics. If eligible for the study, participants will be randomized to complete one study session in our mobile laboratory, during which they will use either alcohol, cannabis (which will be self-administered, ad libitum) or both alcohol and cannabis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21-50 years old
- •Heavy drinkers (consuming more than 4 drinks/day or more than 14 drinks/week for men, or more than 3 drinks/day or more than 7 drinks/week for women)
- •Regular users of legal-market flower cannabis (at least 2x/week in past 3 months)
- •report simultaneously using alcohol and legal-market flower cannabis at least once per month in the past 3 months
- •English speakers.
排除标准
- •Daily tobacco users
- •Diagnosed with or seeking treatment for alcohol use disorder (AUD) or other substance use disorder (SUD)
- •Females cannot be pregnant, breastfeeding or trying to become pregnant
- •Meet criteria for psychotic, bipolar or major depressive disorder with suicidal ideation, or history of these disorders, 5) Current use of psychotropic (except anti-depressants)
- •Report illicit drug use in past 60-days or fail drug screen on the day of the study appointment
- •Major medical condition contraindicating alcohol and/or cannabis consumption.
研究组 & 干预措施
Alcohol Group
Participants in this group will be administered a dose of alcohol by researchers in our mobile lab. The dose is designed (based on participant sex and body weight) to bring blood alcohol concentration to .06 g/dL.
干预措施: Alcohol (Other)
Alcohol + Cannabis Group
Participants in this group will first self-administer their own flower cannabis product (that they purchased for use in the study from a legal-market dispensary) ad libitum inside their homes. Researchers will not handle the product or instruct participants on how much to use during the session. They will then return to the mobile lab which will be parked outside their residence and will be administered a dose of alcohol by researchers. The dose is designed (based on participant sex and body weight) to bring blood alcohol concentration to .06 g/dL.
干预措施: Alcohol (Other)
Alcohol + Cannabis Group
Participants in this group will first self-administer their own flower cannabis product (that they purchased for use in the study from a legal-market dispensary) ad libitum inside their homes. Researchers will not handle the product or instruct participants on how much to use during the session. They will then return to the mobile lab which will be parked outside their residence and will be administered a dose of alcohol by researchers. The dose is designed (based on participant sex and body weight) to bring blood alcohol concentration to .06 g/dL.
干预措施: Cannabis (Other)
Cannabis Group
Participants in this group will self-administer their own flower cannabis product (that they purchased for use in the study from a legal-market dispensary) ad libitum inside their homes. Researchers will not handle the product or instruct participants on how much to use during the session.
干预措施: Cannabis (Other)
结局指标
主要结局
Electroencephalography (EEG) Objective Cognitive Function Measures--Amplitude (microvolts)
时间窗: Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
The EEG amplitude (measured in microvolts) will be obtained while participants perform the speeded visual flanker task
Electroencephalography (EEG) Objective Cognitive Function Measures--Latency (milliseconds)
时间窗: Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
The EEG latency (measured in milliseconds) will be obtained while participants perform the speeded visual flanker task
Standing postural stability
时间窗: Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
An iPod Touch will be attached to each participant's hip with a simple elastic/Velcro strap. An app on the device will record fine grained movements while they try to stand as still as possible for 30-60 seconds under four conditions that vary in terms of demand on the proprioceptive system (eyes open, eyes closed), and on a stable vs. soft (foam) surface.
次要结局
未报告次要终点