NCT05478863

The Pharmacodynamics of Cannabinoid-Caffeine Combinations

A Double-Blind, Randomized, Placebo-Controlled, Within-Subject Crossover Study of the Effects of Combinations of Cannabinoids and Caffeine

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Behavioral Pharmacology of Cannabinoids

Interventions

Type	Name	Description
DRUG	Oral Placebo	Placebo will be orally self-administered by study participants.
DRUG	Oral THC	THC will be orally self-administered by study participants.
DRUG	Oral CBD	CBD will be orally self-administered by study participants.
DRUG	Oral Caffeine	Caffeine will be orally self-administered by study participants.

Timeline

• Start date: 2023-01-20
• Primary completion: 2024-10-02
• Completion: 2024-10-02
• First posted: 2022-07-28
• Last updated: 2024-10-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study