RecruitingPhase 1NCT06058702

Genetics of Cannabis Use Disorder and Cannabinoid Response in Humans


Sponsor

Yale University

Enrollment

215 participants

Start Date

Sep 16, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 YearsMax Age: 60 Years

Inclusion Criteria1

  • Ages 21-60 years old

Exclusion Criteria3

  • Major or unstable medical conditions based on history, the Structured Clinical Interview for DSM-5, collateral information, physical and laboratory examinations, ECG, and vital signs.
  • Cannabis naïve individuals
  • Positive pregnancy test

Interventions

DRUGDelta-9-THC Very Low Dose

Active Delta-9-THC administered intravenously over 20 minutes.

DRUGPlacebo

Control: Small amount of sterile 190 proof USP ethanol (1-2 mLs), with no THC, administered intravenously over 20 minutes.

DRUGDelta-9-THC Medium Dose

Active Delta-9-THC administered intravenously over 20 minutes.


Locations(1)

West Haven Veterans Affairs Medical Center

West Haven, Connecticut, United States

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NCT06058702


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