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Purpose

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

Eligibility

Eligible Ages
Between 21 Years and 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Ages 21-60 years old

Exclusion Criteria

  • 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Other
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Delta-9-THC Very Low Dose 		Active delta-9-THC administered intravenously over 20 minutes.
  • Drug: Delta-9-THC Very Low Dose
    Active Delta-9-THC administered intravenously over 20 minutes.
Placebo Comparator
Placebo 		Control: small amount of alcohol administered intravenously (quarter teaspoon), with no delta-9-THC, 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.
Active Comparator
Delta-9-THC Medium Dose 		Active delta-9-THC administered intravenously over 20 minutes.
  • Drug: Delta-9-THC Medium Dose
    Active Delta-9-THC administered intravenously over 20 minutes.

Recruiting Locations

West Haven Veterans Affairs Medical Center
West Haven, Connecticut 06516
Contact:
Deepak C D'Souza, MD
203-932-5711
deepak.dsouza@yale.edu

More Details

Status
Recruiting
Sponsor
Yale University

Study Contact

Deepak D'Souza, MD
203-932-5711
deepak.douza@yale.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.