The Impact of Oral Cannabis Administration and Co-Administration of Alcohol on Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Cumulative score on Field Sobriety Tests
研究概览
简要总结
This study will evaluate the individual and interactive effects of oral cannabis and alcohol on subjective and behavioral measures of impairment.
详细描述
This clinical laboratory study will be double-blind, placebo-controlled and will utilize a within-subjects experimental design. Participants will complete 7 outpatient drug administration sessions that will consist of self-administration of oral cannabis (0, 10 or 25mg THC) and alcohol (either placebo or active; BAC of 0.05 percent); participants will always receive both an alcohol drink (active or placebo) and dose of cannabis (active or placebo). Participants will also complete a condition in which they administer alcohol (BAC: 0.08 percent) with placebo cannabis, as a positive control. Primary outcomes include performance on field sobriety tests, cognitive and psychomotor impairment, subjective drug effects, and simulated driving performance. Blood concentrations of THC and THC metabolites will also be determined.
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
Double-blind (Participant, Outcomes Assessor), placebo controlled, and double-dummy
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have provided written informed consent
- •Be between the ages of 21 and 55
- •Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
- •Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at each study visit.
- •Have a body mass index (BMI) in the range of 19 to 36 kg/m2
- •Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
- •Have not donated blood in the prior 30 days.
- •Report at least 2 days of binge drinking in the past 90 days (greater than 4 or 5 drinks on a single occasion for women and men, respectively)
- •Report ≥ 1 use of cannabis in the past year
- •Provide negative urine test for illicit drug use (excluding THC) and negative breath alcohol test (0% BAC) at screening and before study sessions
- •Report at least 1 instance of simultaneous alcohol and use in the past year.
排除标准
- •Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in past month
- •Current use of over-the-counter (OTC) drugs, supplements/vitamins, or prescription medications that, in the opinion of the investigator or medical staff, will impact the participant's safety
- •History of or current evidence of significant medical condition
- •Evidence of current psychiatric condition [(MINI for Diagnostic and Statistical Manual (DSM)-V)]
- •Meet criteria for severe alcohol use disorder (MINI for DSM-V)
- •Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar) score > 9
- •Been in treatment previously for alcohol or cannabis use disorder
- •Use of cannabis, on average, more than 2 times/week over past 3 months
- •Liver function tests more than 2x normal range
- •Enrollment in another clinical trial or receiving of any drug as part of research within past 30 days
- •Shipley vocabulary score <18 (corresponds to 5th grade reading level).
研究组 & 干预措施
Placebo cannabis + placebo alcohol
Participants administer oral cannabis containing 0mg THC in combination with a placebo alcohol drink.
干预措施: Cannabis (Drug)
Placebo cannabis + placebo alcohol
Participants administer oral cannabis containing 0mg THC in combination with a placebo alcohol drink.
干预措施: Alcohol (Drug)
low dose cannabis with placebo alcohol
Participants administer oral cannabis containing 10mg THC in combination with a placebo alcohol drink.
干预措施: Cannabis (Drug)
low dose cannabis with placebo alcohol
Participants administer oral cannabis containing 10mg THC in combination with a placebo alcohol drink.
干预措施: Alcohol (Drug)
high dose cannabis with placebo alcohol
Participants administer oral cannabis containing 25mg THC in combination with a placebo alcohol drink.
干预措施: Cannabis (Drug)
high dose cannabis with placebo alcohol
Participants administer oral cannabis containing 25mg THC in combination with a placebo alcohol drink.
干预措施: Alcohol (Drug)
low dose cannabis with low dose alcohol
Participants administer oral cannabis containing 10mg THC in combination with an alcohol drink (0.05 percent BAC).
干预措施: Cannabis (Drug)
low dose cannabis with low dose alcohol
Participants administer oral cannabis containing 10mg THC in combination with an alcohol drink (0.05 percent BAC).
干预措施: Alcohol (Drug)
high dose cannabis with low dose alcohol
Participants administer oral cannabis containing 25mg THC in combination with an alcohol drink (0.05 percent BAC).
干预措施: Cannabis (Drug)
high dose cannabis with low dose alcohol
Participants administer oral cannabis containing 25mg THC in combination with an alcohol drink (0.05 percent BAC).
干预措施: Alcohol (Drug)
Placebo cannabis + low dose alcohol
Participants administer oral cannabis containing 0mg THC in combination with an alcohol drink (0.05 percent BAC).
干预措施: Cannabis (Drug)
Placebo cannabis + low dose alcohol
Participants administer oral cannabis containing 0mg THC in combination with an alcohol drink (0.05 percent BAC).
干预措施: Alcohol (Drug)
Placebo cannabis + high dose alcohol
Participants administer oral cannabis containing 0mg THC in combination with an alcohol drink (0.08 percent BAC).
干预措施: Cannabis (Drug)
Placebo cannabis + high dose alcohol
Participants administer oral cannabis containing 0mg THC in combination with an alcohol drink (0.08 percent BAC).
干预措施: Alcohol (Drug)
结局指标
主要结局
Cumulative score on Field Sobriety Tests
时间窗: 7.5 hours
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 22 clues).
Driving performance as assessed by standard deviation of lateral position (SDLP)
时间窗: 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. SDLP (measured in cm) will be determined during each drive. This measure is a composite index of lateral control and incorporates lane weaving, swerving, and over-correcting. 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.
DRUID application global impairment score
时间窗: 7.5 hours
Acute cognitive and behavioral impairment will be assessed with global impairment score(range 0-100) on the DRUID app (higher scores indicate greater impairment).
Correct Trials on the Digit Symbol Substitution Task (DSST)
时间窗: 7.5 hours
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Will report the total correct trials in 90 seconds (lower scores indicate worse performance).
Drug Effect Questionnaire (DEQ) - Feel Drug Effect
时间窗: 7.5 hours
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.
Drug Effect Questionnaire - Confidence to Drive
时间窗: 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.
Subjective high assessment scale (SHAS)
时间窗: 7.5 hours
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)
Correct Trials on Paced Auditory Serial Addition Task (PASAT)
时间窗: 7.5 hours
Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. Will report the total correct trials out of 90 recorded (lower scores indicate worse performance).
Biphasic alcohol effects scale (BAES) - Sedative Score
时间窗: 7.5 hours
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).
Biphasic alcohol effects scale (BAES) - Stimulant Score
时间窗: 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).
Driving performance as assessed by composite drive score
时间窗: 7.5 hours
Driving impairment will be assessed via a composite drive score (higher scores indicate greater impairment). The composite drive score is derived by integrating various driving outcomes (see primary and secondary driving outcomes). There is no upper or lower limit to possible scores
Drug Effect Questionnaire - Feel High
时间窗: 7.5 hours
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.
Drug Effect Questionnaire - Willingness to Drive
时间窗: 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.
Mean Peak Change From Baseline DRUID Application Global Impairment Score
时间窗: 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.
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.
Cumulative Score on Field Sobriety Tests
时间窗: 7.5 hours
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.
Mean Peak Change From Baseline Scores on the Drug Effect Questionnaire (DEQ) - Feel Drug Effect
时间窗: 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
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.
Drug Effect Questionnaire - Confidence to Drive (Change From Baseline)
时间窗: 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
Biphasic Alcohol Effects Scale (BAES) - Sedative Score
时间窗: Baseline, 7.5 hours
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.
Biphasic Alcohol Effects Scale (BAES) - Stimulant Score
时间窗: 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.
Subjective High Assessment Scale (SHAS)
时间窗: 7.5 hours
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.
Driving Performance as Assessed by Standard Deviation of Lateral Position (SDLP)
时间窗: 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. 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.
Driving Performance as Assessed by Composite Drive Score
时间窗: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
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.
次要结局
- Driving performance (total rule violations)(7.5 hours)
- Reaction time on Paced Auditory Serial Addition Task(7.5 hours)
- Driving performance as assessed by standard deviation of speed (SDSP)(7.5 hours)
- Field Sobriety Test - Score on Walk and Turn test(Up to 7.5 hours)
- Drug Effect Questionnaire - Want more(7.5 hours)
- Driving performance (number of accidents)(7.5 hours)
- Field Sobriety Test - Score on Modified Romberg Balance(Up to 7.5 hours)
- Pharmacokinetics - CMax for THC and THC metabolites(7.5 hours)
- Driving performance (distance to lead vehicles)(7.5 hours)
- Attempted Trials on the Digit Symbol Substitution Task (DSST)(7.5 hours)
- Field Sobriety Test - Score on One Leg Stand(Up to 7.5 hours)
- Pharmacokinetics - AUC for THC and THC metabolites(Up to 7.5 hours)
- Driving performance (mean speed)(7.5 hours)
- Driving performance (number of speed exceedances)(7.5 hours)
- Percentage Correct on attempted trials on the Digit Symbol Substitution Task (DSST)(7.5 hours)
- Field Sobriety Test - Score on Horizontal Gaze Nystagmus Test(Up to 7.5 hours)
- Pharmacokinetics - Breath Alcohol Concentration (BAC)(Up to 7.5 hours)
- Drug Effect Questionnaire - Like Drug Effect(7.5 hours)
- Drug Effect Questionnaire - Dislike Drug Effect(7.5 hours)
- Driving Performance as Assessed by Standard Deviation of Speed (SDSP)(Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours)
- Total Run Length(Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours)
- Driving Performance (Number of Speed Exceedances)(Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours)
- Driving Performance (Number of Accidents)(Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours)
- Driving Performance (Total Rule Violations)(Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours)
- Driving Performance (Distance to Lead Vehicles)(Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours)
- Change in Field Sobriety Test - Score on Horizontal Gaze Nystagmus Test(Baseline, 7.5 hours)
- Change in Field Sobriety Test - Score on Walk and Turn Test(Baseline, 7.5 hours)
- Change in Field Sobriety Test - Score on One Leg Stand(Baseline, 7.5 hours)
- Change in Field Sobriety Test - Score on Modified Romberg Balance(Baseline, 7.5 hours)
- Pharmacokinetics - CMax for THC and THC Metabolites(Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours)
- Pharmacokinetics - AUC for THC and THC Metabolites(Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours)
- Pharmacokinetics - CMax for Alcohol(Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours)
- Pharmacokinetics - AUC for Alcohol(Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours)