A Phase 1 interventional study of Cannabis and 0 mg THC (placebo) in Cannabis Intoxication, sponsored by Johns Hopkins University. Recruiting at 1 site in United States. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Johns Hopkins University · Phase 1, Interventional, and Basic science
This study will evaluate the subjective and behavioral effects of cannabis products labeled as indica, sativa, or generic.
This clinical laboratory study will be double-blind, placebo-controlled and will utilize a within-subjects experimental design. Participants will complete 6 outpatient drug administration sessions that will consist of self-administration of smoked cannabis (0, or 25mg THC) labeled as indica, sativa, or generically-labelled. Primary outcomes include performance on cognitive and psychomotor assessments, subjective drug effects, and simulated driving performance. Smoking topography will also be characterized.
Exclusion Criteria:
Participants administer smoked cannabis labeled as indica containing 0mg THC.
Drug: Cannabis · Other: 0 mg THC (placebo)
Participants administer smoked cannabis labeled as Sativa containing 0mg THC.
Drug: Cannabis · Other: 0 mg THC (placebo)
Participants administer smoked cannabis labeled generically containing 0mg THC.
Drug: Cannabis · Other: 0 mg THC (placebo)
Participants administer smoked cannabis labeled as indica containing 25mg THC.
Drug: Cannabis
Participants administer smoked cannabis labeled as sativa containing 25mg THC.
Drug: Cannabis
Participants administer smoked cannabis labeled generically containing 25mg THC.
Drug: Cannabis
Cannabis will be administered via smoked inhalation.
0 mg THC (placebo)
Number of Correct Trials on Paced Auditory Serial Addition Task (PASAT)
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).
Time frame: Baseline, 0-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing
Driving Under the Influence of Drugs (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).
Time frame: Baseline, 0-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing
Number of Correct Trials on the Digit Symbol Substitution Task (DSST)
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).
Time frame: Baseline, 0-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing
Biphasic alcohol effects scale (BAES) - Sedative Score
The BAES is used to assess sedative and stimulant subjective effects of alcohol. It has been shown to be sensitive to the effects of cannabis too. 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 score more effects.
Time frame: Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing
Biphasic alcohol effects scale (BAES) - Stimulant Score
The BAES is used to assess sedative and stimulant subjective effects of alcohol. It has been shown to be sensitive to the effects of cannabis too. 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 score more effects.
Time frame: Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing
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) 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.
Time frame: Baseline, 0-, 2-, 4-, and 6-hours post dosing.
Driving performance as assessed by global drive score
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
Time frame: Baseline, 0-, 2-, 4-, and 6-hours post dosing.
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.
Time frame: Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing
Drug Effect Questionnaire - Confidence to Drive
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.
Time frame: Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing
Drug Effect Questionnaire - Alert
The DEQ will be used to obtain subjective ratings of "alert". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Time frame: Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing
Drug Effect Questionnaire - Sleepy/Tired
The DEQ will be used to obtain subjective ratings of "sleepy/tired". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Time frame: Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing
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.
Time frame: Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing
Anticipated Effects of Cannabis Scale (AECS) - Creative
The AECS will be used to obtain subjective ratings of "creative". Score range from 0 (none) to 10 (extreme) using a 10mm line anchored with none/extreme designation.
Time frame: Baseline prior to drug administration
Anticipated Effects of Cannabis Scale (AECS) - Drowsy
The AECS will be used to obtain subjective ratings of "Drowsy". Score range from 0 (none) to 10 (extreme) using a 10mm line anchored with none/extreme designation.
Time frame: Baseline prior to drug administration
Plan to share: No
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