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NCT05478863 · ClinicalTrials.gov registry record · Early Phase 1
The Pharmacodynamics of Cannabinoid-Caffeine Combinations
A Early Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
NCT05478863: Completed Early Phase 1 study, sponsored by Johns Hopkins University.
NCT05478863 is a Early Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 20 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05478863, a Early Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Cannabis and caffeine are two of the most commonly consumed psychoactive substances in the world, with many consumers reporting positive impacts on energy, alertness, and focus. Preliminary evidence has suggested that cannabidiol (CBD), the non-intoxicating cannabinoid found in cannabis, may mitigate the negative side effects of caffeine (e.g., feeling jittery) without impacting positive or desired effects. CBD also shows potential in reducing undesirable acute effects (e.g., anxiety) of delta-9-tetrahydrocannabinol (THC), the primary intoxicating cannabinoid found in cannabis. Despite these promising findings, little is known about the potential effects of THC, caffeine, and CBD in combination. This double-blind, randomized, placebo-controlled, within-subject crossover study will assess the effects of combinations of THC, CBD, and caffeine (i.e., THC only; THC + caffeine; THC + CBD + caffeine) on subjective energy, arousal, and cognitive performance.
Primary Outcome
Driving Performance as Measured by the DRiving Under the Influence of Drugs (DRUID®) behavioral task. Higher scores = greater impairment.
Interventions
- DRUG Oral Placebo
- DRUG Oral THC
- DRUG Oral CBD
- DRUG Oral Caffeine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-01-20 |
| Est. Completion | 2024-10-02 |
| Phase | Early Phase 1 |
What the finished NCT05478863 record still lists
NCT05478863 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 4 interventions - of which Oral Placebo is the first listed.
NCT05478863 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05478863 about?
NCT05478863 is a clinical study titled "The Pharmacodynamics of Cannabinoid-Caffeine Combinations". Cannabis and caffeine are two of the most commonly consumed psychoactive substances in the world, with many consumers reporting positive impacts on energy, alertness, and focus. Preliminary evidence has suggested that cannabidiol (CBD), the non-intoxicating cannabinoid found in cannabis, may mitigat...
What is the current status of trial NCT05478863?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2023-01-20. Estimated completion is 2024-10-02.
What interventions are being tested in trial NCT05478863?
The interventions under investigation include: Oral Placebo (DRUG), Oral THC (DRUG), Oral CBD (DRUG), Oral Caffeine (DRUG).
Who is sponsoring clinical trial NCT05478863?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05478863's enrollment target sits among peer trials
20 1157th of 2000 higher than 709 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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