This study will evaluate the individual and interactive effects of oral cannabis and alcohol on subjective and behavioral measures of impairment.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
70
Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States
Mean Peak Change From Baseline DRUID Application Global Impairment Score
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.
Time frame: 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.
Cumulative Score on Field Sobriety Tests
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.
Time frame: 7.5 hours
Mean Peak Change From Baseline Scores on the Drug Effect Questionnaire (DEQ) - Feel Drug Effect
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.
Time frame: 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
Drug Effect Questionnaire - Feel High
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.
Time frame: 7.5 hours
Drug Effect Questionnaire - Confidence to Drive (Change From Baseline)
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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Time frame: 7.5 hours
Drug Effect Questionnaire - Willingness to Drive
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.
Time frame: 7.5 hours
Biphasic Alcohol Effects Scale (BAES) - Sedative Score
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.
Time frame: Baseline, 7.5 hours
Biphasic Alcohol Effects Scale (BAES) - Stimulant Score
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.
Time frame: 7.5 hours
Subjective High Assessment Scale (SHAS)
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.
Time frame: 7.5 hours
Driving Performance as Assessed by Standard Deviation of Lateral Position (SDLP)
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.
Time frame: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Driving Performance as Assessed by Composite Drive Score
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.
Time frame: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Driving Performance as Assessed by Standard Deviation of Speed (SDSP)
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.
Time frame: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Total Run Length
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.
Time frame: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Driving Performance (Number of Speed Exceedances)
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.
Time frame: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Driving Performance (Number of Accidents)
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.
Time frame: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Driving Performance (Total Rule Violations)
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.
Time frame: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Driving Performance (Distance to Lead Vehicles)
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.
Time frame: 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
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
Time frame: Baseline, 7.5 hours
Change in Field Sobriety Test - Score on Walk and Turn Test
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
Time frame: Baseline, 7.5 hours
Change in Field Sobriety Test - Score on One Leg Stand
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
Time frame: Baseline, 7.5 hours
Change in Field Sobriety Test - Score on Modified Romberg Balance
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
Time frame: Baseline, 7.5 hours
Drug Effect Questionnaire - Like Drug Effect
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.
Time frame: 7.5 hours
Drug Effect Questionnaire - Dislike Drug Effect
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.
Time frame: 7.5 hours
Pharmacokinetics - CMax for THC and THC Metabolites
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.
Time frame: 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
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.
Time frame: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Pharmacokinetics - CMax for Alcohol
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.
Time frame: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Pharmacokinetics - AUC for Alcohol
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.
Time frame: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours