A Phase 1 interventional study of 0mg THC + 0mg CBD Brownie and 10mg THC + 0mg CBD Brownie in Cannabis Intoxication, sponsored by Johns Hopkins University. Not yet recruiting at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Johns Hopkins University · Phase 1, Interventional, and Basic science
This study will evaluate the subjective and behavioral effects of cannabis products containing delta-9-tetrahydrocannabinol and cannabidiol
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, or 10mg THC; 0, 10, 50, 100, 300mg CBD). Primary outcomes include performance on cognitive and psychomotor assessments, subjective drug effects, simulated driving performance, and impact on blood pharmacokinetics.
530 studies on the registry are indexed under Marijuana Abuse; 114 are open to participants now.
This study's planned enrollment of 70 is above the median of 60 across 431 interventional studies indexed under Marijuana Abuse.
Browse Marijuana Abuse studies →Johns Hopkins University is the lead sponsor of 1,809 studies on the registry; 314 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants ingest a brownie containing 0mg THC and 0mg CBD.
Drug: 0mg THC + 0mg CBD Brownie
Participants ingest a brownie containing 10mg THC and 0mg CBD.
Drug: 10mg THC + 0mg CBD Brownie
Participants ingest a brownie containing 10mg THC and 10mg CBD.
Drug: 10mg THC + 10mg CBD Brownie
Participants ingest a brownie containing 10mg THC and 50mg CBD.
Drug: 10mg THC + 50mg CBD Brownie
Participants ingest a brownie containing 10mg THC and 100mg CBD.
Drug: 10mg THC + 100mg CBD Brownie
Participants ingest a brownie containing 10mg THC and 300mg CBD.
Drug: 10mg THC + 300mg CBD Brownie
Participants ingest a brownie containing 0mg THC and 300mg CBD.
Drug: 0mg THC + 300mg CBD Brownie
Brownie containing no THC and CBD will be self administered through oral ingestion.
Brownie containing 10mg THC and no CBD will be self administered through oral ingestion.
Brownie containing 10mg THC and 10mg CBD will be self administered through oral ingestion.
Brownie containing 10mg THC and 50mg CBD will be self administered through oral ingestion.
Brownie containing 10mg THC and 100mg CBD will be self administered through oral ingestion.
Brownie containing 10mg THC and 300mg CBD will be self administered through oral ingestion.
Brownie containing no THC and 300mg CBD will be self administered through oral ingestion.
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, , 2-, 4-, 6-, 8-hours post dosing.
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, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 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, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 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, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing
Driving performance as assessed by global drive score during the simulated driving task
Driving impairment will be assessed using a composite driving score, with higher scores indicating greater impairment. The composite score is calculated by converting individual driving outcomes (see primary and secondary driving outcomes) into standardized z-scores and averaging these values to generate an overall composite score. Individual z-scores have a mean of 0 and a standard deviation (SD) of 1 in the reference sample used for standardization. The composite score has an expected mean of 0 in the reference sample, while its SD depends on the correlations among the individual driving outcomes and is not necessarily 1.
Time frame: Baseline, 2, 4, 6, and 8 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, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing.
Drug Effect Questionnaire (DEQ) - Drug Liking
The DEQ will be used to obtain subjective ratings of "drug liking". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Time frame: Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 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, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing.
Heart Rate - Beats per Minute
Beats per minute will be used to assess affects on heart rate.
Time frame: Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing.
Whole Blood Concentrations - THC Concentrations
Blood THC concentrations will be measured to assess changing in blood concentrations following drug administration.
Time frame: Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2027; primary completion for Feb 2029, 24 months later.
Of 51 non-industry phase 1 interventional studies under Marijuana Abuse, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 46. This study's planned 24 months is below that.
Counting every sponsor, half of 55 studies reached it within 27 months; a quarter within 12 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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