NCT06378957

Behavioral Pharmacology of Orally Administered THC and D-limonene

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The current clinical trial will investigate the effects of orally administered d-limonene (limonene), delta-9-tetrahydrocannabinol (THC) and the combination in healthy adult volunteers.

Detailed description

The current clinical trial will investigate the interaction of orally administered d-limonene (limonene) and delta-9-tetrahydrocannabinol (THC). Limonene is a flavor/fragrance component common to many plants, including cannabis. The investigators have previously demonstrated that vaporized limonene can impact the acute effects of THC. The purpose of this study is to examine whether orally administered limonene modulates the acute effects of orally co-administered THC in a manner similar to when these substances are inhaled A controlled laboratory study will be completed at Johns Hopkins evaluating placebo, THC alone, and four ascending doses of d-limonene in combination with THC. Participants will be healthy adults with experience using cannabis. A total of 6 outpatient drug administration sessions will be conducted for each evaluable participant. The investigators will recruit study volunteers until 20 participants complete the protocol.

Conditions

• Subjective Drug Effects
• THC
• D-limonene

Interventions

Type	Name	Description
DRUG	D-Limonene	Oral Limonene administered via capsule
DRUG	Delta-9-THC	Oral delta-9-THC in ethanol vehicle administered via capsule
DRUG	Placebo	Placebo (cellulose) administered via capsule

Timeline

• Start date: 2025-02-14
• Primary completion: 2027-07-01
• Completion: 2027-12-31
• First posted: 2024-04-23
• Last updated: 2025-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study