口服大麻和联合服用酒精对损伤的影响
2026年7月29日 更新者：Johns Hopkins University
本研究将评估口服大麻和酒精对主观和行为损伤测量的个体和相互作用影响。
研究概览
详细说明
这项临床实验室研究将是双盲、安慰剂对照的，并将采用受试者内实验设计。
参与者将完成 7 个门诊药物管理课程，其中包括自我管理口服大麻（0、10 或 25 毫克四氢大麻酚）和酒精（安慰剂或活性药物；BAC 为 0.05%）；参与者将始终接受酒精饮料（活性或安慰剂）和大麻剂量（活性或安慰剂）。
参与者还将完成一项条件，在该条件下，他们将酒精（BAC：0.08%）与安慰剂大麻一起作为阳性对照。
主要结果包括现场清醒测试的表现、认知和精神运动障碍、主观药物影响和模拟驾驶表现。
还将确定 THC 和 THC 代谢物的血液浓度。
研究类型
介入性
注册 (实际的)
70
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Maryland
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Baltimore、Maryland、美国、21224
- Johns Hopkins Behavioral Pharmacology Research Unit
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 至 55年 (成人)
接受健康志愿者
是的
描述
纳入标准：
- 已提供书面知情同意书
- 年龄介于 21 至 50 岁之间
- 根据身体检查、病史、生命体征以及尿液和血液检查筛查，总体健康状况良好
- 没有怀孕或哺乳（如果是女性）。 所有女性必须在筛选访视时进行阴性血清妊娠试验，并在每次研究访视时进行阴性尿液妊娠试验。
- 体重指数 (BMI) 在 19 至 36 kg/m2 范围内
- 筛选访问时的血压不超过 150 mmHg 的收缩压 (SBP) 或 90 mmHg 的舒张压 (DBP)
- 在过去 30 天内没有献过血。
- 报告在过去 90 天内至少有 2 天狂饮（女性和男性单次分别饮酒超过 4 次或 5 次）
- 报告在过去一年中使用大麻的次数≥ 5 次
- 在筛选和研究会议之前提供用于非法药物使用的阴性尿液测试（不包括 THC）和阴性呼气酒精测试（0% BAC）
- 报告在过去一年中至少有 1 起同时饮酒和使用的情况。
排除标准：
- 上个月使用精神药物（大麻、尼古丁、酒精或咖啡因除外）
- 当前使用研究人员或医务人员认为会影响参与者安全的非处方药 (OTC)、补充剂/维生素或处方药
- 重大医疗状况的历史或当前证据
- 当前精神状况的证据 [(MINI for Diagnostic and Statistical Manual (DSM)-V)]
- 符合严重酒精使用障碍的标准（DSM-V 的 MINI）
- 临床研究所酒精戒断评估量表 (CIWA-Ar) 得分 > 9
- 之前因酒精或大麻使用障碍接受过治疗
- 在过去 3 个月内平均每周使用大麻超过 2 次
- 肝功能测试超过正常范围的 2 倍
- 在过去 30 天内参加另一项临床试验或接受任何药物作为研究的一部分
- Shipley 词汇得分 <18（相当于 5 年级阅读水平）。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：安慰剂大麻 + 安慰剂酒精
参与者将含有 0 毫克四氢大麻酚的口服大麻与安慰剂酒精饮料结合使用。
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大麻将通过核仁巧克力饼口服摄入
酒精将通过调味饮料口服摄入
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实验性的：含安慰剂酒精的低剂量大麻
参与者将含有 10 毫克四氢大麻酚的口服大麻与安慰剂酒精饮料结合使用。
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大麻将通过核仁巧克力饼口服摄入
酒精将通过调味饮料口服摄入
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实验性的：含安慰剂酒精的高剂量大麻
参与者将含有 25 毫克四氢大麻酚的口服大麻与安慰剂酒精饮料结合使用。
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大麻将通过核仁巧克力饼口服摄入
酒精将通过调味饮料口服摄入
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实验性的：低剂量大麻和低剂量酒精
参与者将含有 10 毫克 THC 的口服大麻与酒精饮料（0.05% BAC）结合使用。
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大麻将通过核仁巧克力饼口服摄入
酒精将通过调味饮料口服摄入
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实验性的：高剂量大麻和低剂量酒精
参与者将含有 25 毫克 THC 的口服大麻与酒精饮料（0.05% BAC）结合使用。
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大麻将通过核仁巧克力饼口服摄入
酒精将通过调味饮料口服摄入
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实验性的：安慰剂大麻 + 低剂量酒精
参与者将含有 0 毫克 THC 的口服大麻与酒精饮料（0.05% BAC）结合使用。
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大麻将通过核仁巧克力饼口服摄入
酒精将通过调味饮料口服摄入
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实验性的：安慰剂大麻 + 高剂量酒精
参与者将含有 0 毫克 THC 的口服大麻与酒精饮料（0.08% BAC）结合使用。
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大麻将通过核仁巧克力饼口服摄入
酒精将通过调味饮料口服摄入
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mean Peak Change From Baseline DRUID Application Global Impairment Score
大体时间：7.5 hours, assessed at baseline (prior to drug administration) and again 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours after oral cannabis ingestion.
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Acute cognitive and behavioral impairment will be assessed with global impairment score (range 0-100) on the DRUID app (higher scores indicate greater impairment).
Results are mean change from baseline.
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7.5 hours, assessed at baseline (prior to drug administration) and again 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours after oral cannabis ingestion.
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Cumulative Score on Field Sobriety Tests
大体时间：7.5 hours
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Impairment will be assessed using a battery of standard field sobriety tests including: the Horizontal Gaze Nystagmus Test (HGN), the Walk and Turn, the One Leg Stand, and the Modified Romberg Balance.
We will report the cumulative amount of clues observed across these tasks (out of a possible 0-22 clues).
Higher scores indicate greater/worse impairment.
These assessments were completed once after 7.5 hours.
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7.5 hours
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Mean Peak Change From Baseline Scores on the Drug Effect Questionnaire (DEQ) - Feel Drug Effect
大体时间：7.5 hours, assessed at baseline (prior to drug administration) and again 0.5, 1, 1.25, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours after oral cannabis ingestion
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The DEQ will be used to obtain subjective ratings of "feel drug effects".
Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Results are mean change from baseline and a higher score indicates a more extreme/worse drug effect.
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7.5 hours, assessed at baseline (prior to drug administration) and again 0.5, 1, 1.25, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours after oral cannabis ingestion
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Drug Effect Questionnaire - Feel High
大体时间：7.5 hours
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The DEQ will be used to obtain subjective ratings of "feel high".
Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Higher score greater "feel high" rating.
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7.5 hours
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Drug Effect Questionnaire - Confidence to Drive (Change From Baseline)
大体时间：7.5 hours
|
The DEQ will be used to obtain subjective ratings of "confidence to drive".
Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Higher scores indicate higher confidence to drive.
Results expressed as change from baseline
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7.5 hours
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Drug Effect Questionnaire - Willingness to Drive
大体时间：7.5 hours
|
The DEQ will be used to obtain subjective ratings of "willingness to drive".
Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Higher score indicates higher willingness to drive.
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7.5 hours
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Biphasic Alcohol Effects Scale (BAES) - Sedative Score
大体时间：Baseline, 7.5 hours
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The BAES is used to assess sedative and stimulant subjective effects of alcohol.
There are 7 sedative-related questionnaire items, each presented on a scale of 0 (not at all) to 10 (extremely), which are integrated to produce an overall sedative score (0-70).
Higher scores indicating greater sedative effects of alcohol.
Scores presented show the change from baseline to 7.5 hours.
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Baseline, 7.5 hours
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Biphasic Alcohol Effects Scale (BAES) - Stimulant Score
大体时间：7.5 hours
|
The BAES is used to assess sedative and stimulant subjective effects of alcohol.
There are 7 stimulant-related questionnaire items, each presented on a scale of 0 (not at all) to 10 (extremely), which are integrated to produce an overall stimulant score (0-70).
Higher scores indicating greater stimulant effects of alcohol.
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7.5 hours
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Subjective High Assessment Scale (SHAS)
大体时间：7.5 hours
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For the SHAS, participants are presented with 13 questionnaire items, displayed on a visual analog scale anchored from 0 (normal) to 10 (extremely), which assess subjective effects of alcohol.
These items are integrated to produce an overall SHAS score (0-130).
Higher score indicates greater effects of alcohol.
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7.5 hours
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Driving Performance as Assessed by Standard Deviation of Lateral Position (SDLP)
大体时间：Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
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The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions.
SDLP (measured in cm) was calculated across all drives to get a composite index of lateral control and reported as peak change from baseline.
SDLP is the gold standard of quantifying the magnitude of driving impairment from drugs and alcohol and has excellent predictive validity to actual driving.
Scores range from 0 to no upper limit.
Higher scores represent higher magnitude of driving impairment.
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Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
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Driving Performance as Assessed by Composite Drive Score
大体时间：Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
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Driving impairment will be assessed via a composite drive score.
The composite drive score is derived by integrating various driving outcomes (see primary and secondary driving outcomes).
Higher z-score indicates worse performance.
The score is on a z-score scale, meaning a score of 1 equates to 1 standard deviation outside of the participants' mean baseline performance and a Z-score of 0 represents the mean baseline performance.
This was calculated across all drives and reported as peak change from baseline.
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Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Driving Performance as Assessed by Standard Deviation of Speed (SDSP)
大体时间：Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions.
SDSP will be calculated across all drives to get a composite index of the variability in speed (measured in MPH) and is reported as peak change from baseline.
Scores range from 0 to no upper limit.
Higher scores represent higher magnitude of driving impairment.
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Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
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Total Run Length
大体时间：Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions.
Total run length will be calculated across all drives and measured as peak change from baseline score (in seconds).
Higher scores represent higher magnitude of driving impairment.
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Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
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Driving Performance (Number of Speed Exceedances)
大体时间：Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions.
Driving performance will be calculated across all drives to get a cumulative number of times participants exceed the allowable speed limit and reported as peak change from baseline.
Scores range from 0 to no upper limit.
Higher scores represent higher numbers of speed exceedances.
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Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
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Driving Performance (Number of Accidents)
大体时间：Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions.
Driving performance will be calculated across all drives to get a cumulative number of accidents (including car collisions, pedestrians hit, etc.) and reported as peak change from baseline.
Scores range from 0 to no upper limit.
Higher scores represent higher numbers of accidents.
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Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
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Driving Performance (Total Rule Violations)
大体时间：Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions.
Driving performance will be calculated across all drives to get a cumulative number of total rule violations (including number of missed stop signs, illegal turns, speed exceedances, etc.) and reported as peak change from baseline.
Scores range from 0 to no upper limit.
Higher scores represent higher numbers of rule violations.
All scores reported are relative to baseline, thus negative values represent a lower number of rule violations than at baseline.
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Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
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Driving Performance (Distance to Lead Vehicles)
大体时间：Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions.
Driving performance will be calculated across all drives to get the mean distance (in meters) maintained to lead vehicles during car-following segments and reported as peak change from baseline.
Scores range from 0 to no upper limit.
Higher scores represent greater distance maintained to lead vehicles.
All scores reported are relative to baseline, thus negative values represent a shorter distance maintained than at baseline.
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Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
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Change in Field Sobriety Test - Score on Horizontal Gaze Nystagmus Test
大体时间：Baseline, 7.5 hours
|
Impairment will be assessed using performance on the Horizontal Gaze Nystagmus Test (HGN).
Total score will be recorded (out of possible 0-6 clues) with higher scores indicating higher impairment.
Assessed at baseline and 7.5 hours, change from baseline to 7.5 hours reported
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Baseline, 7.5 hours
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Change in Field Sobriety Test - Score on Walk and Turn Test
大体时间：Baseline, 7.5 hours
|
Impairment will be assessed using performance on the the Walk and Turn.
Total score will be recorded (out of a possible 0-8 clues) with higher scores indicating higher impairment.
Assessed at baseline and 7.5 hours, change from baseline to 7.5 hours reported
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Baseline, 7.5 hours
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Change in Field Sobriety Test - Score on One Leg Stand
大体时间：Baseline, 7.5 hours
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Impairment will be assessed using performance on the One Leg Stand test.
Total score will be recorded (out of a possible 0-4 clues) with higher scores indicating higher impairment.
Assessed at baseline and 7.5 hours, change from baseline to 7.5 hours reported
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Baseline, 7.5 hours
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Change in Field Sobriety Test - Score on Modified Romberg Balance
大体时间：Baseline, 7.5 hours
|
Impairment will be assessed using performance on the Modified Romberg Balance test.
Total score will be recorded (out of a possible 0-4 clues) with higher scores indicating higher impairment.
Assessed at baseline and 7.5 hours, change from baseline to 7.5 hours reported
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Baseline, 7.5 hours
|
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Drug Effect Questionnaire - Like Drug Effect
大体时间：7.5 hours
|
The DEQ will be used to obtain subjective ratings of "like drug effect".
Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Higher score indicating greater "liked drug effect" rating.
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7.5 hours
|
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Drug Effect Questionnaire - Dislike Drug Effect
大体时间：7.5 hours
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The DEQ will be used to obtain subjective ratings of "dislike drug effect".
Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Higher score indicating greater "dislike drug effect" rating.
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7.5 hours
|
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Pharmacokinetics - CMax for THC and THC Metabolites
大体时间：Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
Whole blood concentrations of THC, 11-OH-THC, and THCCOOH will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis.
The maximum concentration (Cmax) is determined as the highest concentration reached for each individual (ng/mL) across all timepoints.
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Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
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Pharmacokinetics - AUC for THC and THC Metabolites
大体时间：Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
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Whole blood concentrations of THC, 11-OH-THC, and THCCOOH will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis.
The area under the curve (AUC) is calculated cumulative across all timepoints.
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Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
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Pharmacokinetics - CMax for Alcohol
大体时间：Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
BAC will be measured using the Alco-Sensor IV.
Measuring BAC is needed to confirm that participants reached the targeted BAC for a given session and to confirm adherence to pre-session alcohol abstinence requirements (g/210L).
The maximum concentration (Cmax) is determined as the highest concentration reached for each individual (ng/mL) across all timepoints.
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Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
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Pharmacokinetics - AUC for Alcohol
大体时间：Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
Whole blood concentrations of Alcohol will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis.
The area under the curve (AUC) is calculated cumulative across all timepoints.
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Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Tory Spindle, PhD、Johns Hopkins University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年2月17日
初级完成 (实际的)
2025年8月15日
研究完成 (实际的)
2025年8月15日
研究注册日期
首次提交
2021年6月11日
首先提交符合 QC 标准的
2021年6月11日
首次发布 (实际的)
2021年6月18日
研究记录更新
最后更新发布 (实际的)
2026年8月3日
上次提交的符合 QC 标准的更新
2026年7月29日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.