Genetics of Cannabis Use Disorder and Cannabinoid Response in Humans

Yale University

Status and phase: Enrolling; Phase 1

Conditions: Cannabis Use Disorder; Schizophrenia

Treatments: Drug: Placebo; Drug: Delta-9-THC Very Low Dose; Drug: Delta-9-THC Medium Dose

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06058702

2000036194

RO1 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 215 estimated patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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215 participants in 3 patient groups, including a placebo group

Delta-9-THC Very Low Dose

Active Comparator group

Description:

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

Treatment:

Drug: Delta-9-THC Very Low Dose

Placebo

Placebo Comparator group

Description:

Control: small amount of alcohol administered intravenously (quarter teaspoon), with no delta-9-THC, over 20 minutes.

Treatment:

Drug: Placebo

Delta-9-THC Medium Dose

Active Comparator group

Description:

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

Treatment:

Drug: Delta-9-THC Medium Dose