Genetic Basis of the Risk and Consequences of Cannabis Exposure in Humans

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-60
SponsorYale University

About this trial

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 criteria

Qualifiers

None

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Delta-9-THC Very Low Dose
  • Placebo
  • Delta-9-THC Medium Dose

Treatment groups

215 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Yale University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator