NCT06058702

Genetics of Cannabis Use Disorder and Cannabinoid Response in Humans

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 215 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Cannabis is widely used worldwide and is associated with negative outcomes including cannabis use disorder (CanUD), psychosis, and cognitive impairment amongst others. Given the legalization of "recreational" and "medical" cannabis globally, the increasing availability of cannabis, the higher potency of cannabis, the availability of highly potent cannabinoid products, the commercialization of cannabis, and the rising rates of cannabis use, it is critical to understand how genetic factors influence 1) an individual's vulnerability for addiction and psychosis, 2) the response to cannabinoids, 3) the response to novel treatments for CanUD. CanUD is strongly genetically influenced; the investigators published the first CanUD genomewide association study (GWAS) with genomewide-significant results; however, the precise nature of the contribution of genetic factors in the development of CanUD is still not clear. Cannabis exposure has also been linked to a number of psychosis outcomes including schizophrenia (SCZ). SCZ is highly heritable and population-based and genetics studies both support a bidirectional genetic relationship between SCZ and CanUD. However, the precise contribution of genetic factors in the development of psychosis outcomes related to cannabis are not clear.

Conditions

• Schizophrenia
• Cannabis Use Disorder

Interventions

Type	Name	Description
DRUG	Delta-9-THC Very Low Dose	Active Delta-9-THC administered intravenously over 20 minutes.
DRUG	Placebo	Control: Small amount of sterile 190 proof USP ethanol (1-2 mLs), with no THC, administered intravenously over 20 minutes.
DRUG	Delta-9-THC Medium Dose	Active Delta-9-THC administered intravenously over 20 minutes.

Timeline

• Start date: 2024-09-16
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2023-09-28
• Last updated: 2025-07-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study