Genetics of Cannabis Use Disorder and Cannabinoid Response in Humans

Conditions

• Cannabis Use Disorder
• Schizophrenia

Eligibility Criteria

Sex

ALL

Age

21 Years - 60 Years

Healthy Volunteers

Accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Sep 16, 2024

Status verified

Jul 2025

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

215 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Arms

• Active Comparator: 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.
• Active Comparator: Delta-9-THC Medium Dose
  Active delta-9-THC administered intravenously over 20 minutes.

Primary Outcome Measure

Visual Analog Scale (VAS) [ Time Frame: Measured at baseline, 20 minutes, 45 minutes, 90 minutes, 140 minutes, 165 minutes, 210 minutes, 270 minutes, and 360 minutes after the start of the initial THC/placebo drug infusion. ]

Central Contacts

• Deepak D'Souza, MD
  203-932-5711
  [email protected]

Locations (1)

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