The Impact of Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Driving performance as assessed by standard deviation of lateral position (SDLP)
研究概览
简要总结
This human laboratory study will use cognitive, behavioral, and subjective measures to characterize impairment associated with co-use of alcohol and vaporized cannabis. Participants (n=32) will complete 7 double-blind, double-dummy outpatient sessions in randomized order. In each session, participants will self-administer placebo (0 mg THC) or active vaporized cannabis (5 or 25 mg THC, via a handheld vaporizer called the Mighty Medic) and a placebo drink (BAC 0.0%) or alcohol drink calculated to produce a breath alcohol concentration (BAC) of 0.05%. Participants will also complete a positive control session in which the participant administers placebo cannabis and alcohol at a target BAC of 0.08% (the legal threshold for driving impairment in most U.S. states).
详细描述
This study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). Participants will complete a screening visit, and, if eligible, will then complete 7 experimental drug administration sessions in randomized order where the participant will vaporize cannabis-containing capsules (or "pods") (containing 0, 5, or 25mg THC) with a drink that contains no alcohol or alcohol (alcohol-containing drinks will be calculated to produce a breath alcohol concentration, BAC, of 0.05%). There is also a positive control session where participants will vaporize placebo cannabis with an alcohol drink calculated to produce a BAC of 0.08%. Each session will last approximately 8 hours and will be separated by at least 48 hours to allow for sufficient drug washout. Participants may complete up to 2 sessions per week. Drugs will be administered in a double-blind and double-dummy fashion (i.e., participants will always receive both active or placebo cannabis and active or placebo alcohol). During each session, a battery of assessments including blood collection, subjective questionnaire administration, cognitive performance testing, and simulated driving will be conducted.
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
- Triple (Participant, Care Provider, 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have provided written informed consent
- •Be at least 21 years of age
- •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 not donated blood in the prior 30 days
- •Report at least 1 day of binge drinking in the past 3 months (greater than 4 or 5 drinks on a single occasion for women and men, respectively)
- •Report at least 1 use of cannabis in the past 3 years
- •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 lifetime instance of simultaneous alcohol and cannabis use
- •Current concomitant prescription medication use that may interact with the investigational study drug, including inhibitors and inducers of CYP2CP and CYP3A4 as well as highly-protein bound drugs and drugs with a narrow therapeutic index such as warfarin, cyclosporine, and amphotericin B
排除标准
- •Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in the past month
- •History of or current evidence of significant medical condition that would put the participant at risk
- •Evidence of current psychiatric condition (MINI for DSM-V)
- •Meet criteria for severe alcohol use disorder (MINI for DSM-V)
- •CIWA-Ar score > 9
- •Use of cannabis, on average, more than 3 days/week over past 3 months
- •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 vaporized cannabis containing 0mg THC in combination with a placebo alcohol drink.
干预措施: Placebo Alcohol (Drug)
Low dose cannabis with placebo alcohol
Participants administer vaporized cannabis containing 5mg THC in combination with a placebo alcohol drink.
干预措施: Cannabis (Drug)
High dose cannabis with low dose alcohol
Participants administer vaporized cannabis containing 25mg THC in combination with an alcohol drink (0.05 percent BAC).
干预措施: Cannabis (Drug)
Placebo cannabis + low dose alcohol
Participants administer vaporized cannabis containing 0mg THC in combination with an alcohol drink (0.05 percent BAC).
干预措施: Placebo Cannabis (Drug)
Placebo cannabis + low dose alcohol
Participants administer vaporized 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 vaporized cannabis containing 0mg THC in combination with an alcohol drink (0.08 percent BAC).
干预措施: Alcohol (Drug)
Placebo cannabis + placebo alcohol
Participants administer vaporized cannabis containing 0mg THC in combination with a placebo alcohol drink.
干预措施: Placebo Cannabis (Drug)
Low dose cannabis with placebo alcohol
Participants administer vaporized cannabis containing 5mg THC in combination with a placebo alcohol drink.
干预措施: Placebo Alcohol (Drug)
Placebo cannabis + high dose alcohol
Participants administer vaporized cannabis containing 0mg THC in combination with an alcohol drink (0.08 percent BAC).
干预措施: Placebo Cannabis (Drug)
High dose cannabis with placebo alcohol
Participants administer vaporized cannabis containing 25mg THC in combination with a placebo alcohol drink.
干预措施: Placebo Alcohol (Drug)
High dose cannabis with placebo alcohol
Participants administer vaporized cannabis containing 25mg THC in combination with a placebo alcohol drink.
干预措施: Cannabis (Drug)
Low dose cannabis with low dose alcohol
Participants administer vaporized cannabis containing 5mg THC in combination with an alcohol drink (0.05 percent BAC).
干预措施: Alcohol (Drug)
Low dose cannabis with low dose alcohol
Participants administer vaporized cannabis containing 5mg 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 vaporized cannabis containing 25mg THC in combination with an alcohol drink (0.05 percent BAC).
干预措施: Alcohol (Drug)
结局指标
主要结局
Driving performance as assessed by standard deviation of lateral position (SDLP)
时间窗: Up to 6 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.
Drug Effect Questionnaire (DEQ) - Willingness to Drive
时间窗: Up to 6 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.
Biphasic alcohol effects scale (BAES) - Stimulant Score
时间窗: Up to 6 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).
DRUID application global impairment score
时间窗: Up to 6 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 Paced Auditory Serial Addition Task (PASAT)
时间窗: Up to 6 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). Score ranges from 0-90, with 0 representing no correct trials and 90 representing 100% correct trials.
Correct Trials on the Digit Symbol Substitution Task (DSST)
时间窗: Up to 6 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). There is no maximum score, with a score of 0 representing either no trials completed or no correct trials. The score reflects the number of correct trials.
Cumulative score on Field Sobriety Tests
时间窗: Up to 6 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. The cumulative amount of clues observed across these tasks (out of a possible 22 clues) will be reported.
Drug Effect Questionnaire (DEQ) - Feel Drug Effect
时间窗: Up to 6 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 (DEQ) - Feel High
时间窗: Up to 6 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.
Biphasic alcohol effects scale (BAES) - Sedative Score
时间窗: Up to 6 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).
Subjective high assessment scale (SHAS)
时间窗: Up to 6 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)
Drug Effect Questionnaire (DEQ) - Confidence to Drive
时间窗: Up to 6 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.
Driving performance as assessed by composite drive score
时间窗: Up to 6 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. There is no upper or lower limit to possible scores.
次要结局
- Driving performance (number of speed exceedances)(Up to 6 hours)
- Driving performance (number of accidents)(Up to 6 hours)
- Driving performance (total rule violations)(Up to 6 hours)
- Percentage Correct on attempted trials on the Digit Symbol Substitution Task (DSST)(Up to 6 hours)
- Field Sobriety Test - Score on Horizontal Gaze Nystagmus Test(Up to 6 hours)
- Field Sobriety Test - Score on Walk and Turn test(Up to 6 hours)
- Field Sobriety Test - Score on Modified Romberg Balance(Up to 6 hours)
- Driving performance (distance to lead vehicles)(Up to 6 hours)
- Attempted Trials on the Digit Symbol Substitution Task (DSST)(Up to 6 hours)
- Reaction time on Paced Auditory Serial Addition Task(Up to 6 hours)
- Field Sobriety Test - Score on One Leg Stand(Up to 6 hours)
- Drug Effect Questionnaire - Want more(Up to 6 hours)
- Drug Effect Questionnaire - Dislike Drug Effect(Up to 6 hours)
- Pharmacokinetics - AUC for THC and THC metabolites(Up to 6 hours)
- Pharmacokinetics - Breath Alcohol Concentration (BAC)(Up to 6 hours)
- Driving performance as assessed by standard deviation of speed (SDSP)(Up to 6 hours)
- Driving performance (mean speed)(Up to 6 hours)
- Drug Effect Questionnaire - Like Drug Effect(Up to 6 hours)
- Pharmacokinetics - CMax for THC and THC metabolites(Up to 6 hours)