Vaporized Cannabis and Alcohol Impairment Study
This study is looking at how vaporized cannabis and alcohol, alone and together, affect your body and mind. Researchers want to understand how these substances impact your ability to think, behave, and perform tasks. You might be eligible if you are at least 21 years old and in good general health. The study will test different amounts of vaporized cannabis (0, 5, or 25 mg THC) and alcohol (to reach a breath alcohol concentration, or BAC, of 0.05% or 0.08%). Success in this study will be measured by changes in your global impairment score, and how well you perform on specific cognitive tests like the Paced Auditory Serial Addition Task (PASAT) and the Digit Symbol Substitution Task (DSST). The current recruitment status is unclear.
- Study design
- This is an interventional study with 90 planned participants, though the 'About' section mentions 32. It is a double-blind, double-dummy study, meaning neither you nor the researchers will know which substance you are receiving.
- What's involved
- You would complete a screening visit and then 7 experimental drug administration sessions, each lasting about 8 hours. These sessions would be separated by at least 48 hours, and you could complete up to 2 sessions per week.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your impairment and cognitive performance will be measured for up to 6 hours after receiving the interventions.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Tory Spindle, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University
Who to contact
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What this trial measures
- DRUID application global impairment scoreUp 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)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)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 TestsUp 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 EffectUp 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 HighUp 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.
- Drug Effect Questionnaire (DEQ) - Confidence to DriveUp 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.
- Drug Effect Questionnaire (DEQ) - Willingness to DriveUp 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) - Sedative ScoreUp 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).
- Biphasic alcohol effects scale (BAES) - Stimulant ScoreUp 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).
- Subjective high assessment scale (SHAS)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)
- Driving performance as assessed by standard deviation of lateral position (SDLP)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.
- Driving performance as assessed by composite drive scoreUp 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.