Exploring the Effects of Acute Cannabidiol Administration on Blood Alcohol Level and Intoxication in Adult Human Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Breath Alcohol Concentration (BrAC)
研究概览
简要总结
The main objectives of this study were to test if 2 different doses of Cannabidiol (compared to placebo) alter 1) breath alcohol concentration, 2) craving and subjective responses to alcohol or 3) cognitive performance following a standard dose of alcohol.
详细描述
Cannabidiol (CBD), is commonly found in the cannabis plant and has shown promise in treating alcohol use disorders (AUD). In this within-subjects, placebo-controlled, crossover study, the investigators explored the effects of two doses (200mg and 30mg) of plant-based CBD (compared to placebo CBD) on blood alcohol level, subjective effects of alcohol, craving and cognition over the course 4 hours after subjects consume a standardized dose of alcohol.
This pilot study was conducted at Colorado State University and volunteers were recruited from the local community. 36 individuals completed at least 1 study session and 22 completed all three sessions. At each session they received either placebo 30mg oral CBD or 200mg oral CBD prior to being given a standard dose of alcohol. They then remained in our laboratory for 4 hours and completed cognitive testing using the NIH toolbox Cognitive Battery, breath alcohol level measurements and self-reported intoxication ratings (using the The Biphasic Alcohol Effects Scale [BAES] and the The Subjective Effects of Alcohol Scale [SEAS]) and reported their craving levels using the Alcohol Urge Questionnaire (AUQ) every 30 minutes. They also provided 3 blood samples to measure blood-CBD levels at each session (prior to receiving the CBD, 25 minutes post-CBD ingestion and again 60 minutes later). Study sessions were separated by at least one week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21-60 years old
- •able to provide consent
- •willing to consume CBD during the study
- •report heavy drinking (>5 drinks [>4 for women] per occasion on at least 5 days/month in the past 3 months)
- •not cannabis/CBD naive (i.e. THC or CBD use at least once in the past year), do not use cannabis regularly (i.e., less than monthly over past year), and no past-month cannabis use.
排除标准
- •a regular or recent cannabis user (i.e. they used cannabis more often than monthly during the past year or used cannabis in the past month)
- •were seeking treatment a substance use disorder (SUD) including AUD, taking medications to treat bipolar or psychotic disorders
- •using nicotine every day
- •taking blood thinning medications
- •reported having a major medical condition contraindicating alcohol or CBD use (e.g., liver disease or heart disease)
- •reported current suicidality
- •met criteria for psychotic disorder, bipolar disorder or a current major depressive episode,
- •reported using illicit drugs in the 30 days prior to beginning the study or tested positive for any illicit drugs
- •were pregnant, breastfeeding or trying to become pregnant.
结局指标
主要结局
Breath Alcohol Concentration (BrAC)
时间窗: Timepoint 9 (30 minutes after Timepoint 8)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
时间窗: Timepoint 9 (30 minutes after Timepoint 8)
BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated.
Biphasic Effects of Alcohol--Sedation Subscale
时间窗: Timepoint 9 (30 minutes after Timepoint 8)
BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated
Alcohol Urge Questionnaire (AUQ
时间窗: Timepoint 9 (30 minutes after Timepoint 8)
The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse
次要结局
未报告次要终点