Clinical trial NCT06058702: Genetics of Cannabis Use Disorder and Cannabinoid Response in Humans
Official title: Genetics of Cannabis Use Disorder and Cannabinoid Response in Humans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Schizophrenia
Cannabis Use Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-09-28
Enrollment: 215
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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 criteria: 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

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 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.
measure: Positive and Negative Symptom Scale (PANSS)
timeFrame: Measured at baseline, 45 minutes, 90 minutes, 165 minutes, 210 minutes, and 360 minutes after the start of the initial THC/placebo drug infusion.
measure: Clinician Administered Dissociative Symptoms Scale (CADSS),
timeFrame: Measured at baseline, 45 minutes, 90 minutes, 165 minutes, 210 minutes, and 360 minutes after the start of the initial THC/placebo drug infusion.
measure: CogState Battery
timeFrame: Measured at baseline, 45 minutes, and 165 minutes after the start of the initial THC/placebo drug infusion.
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: West Haven Veterans Affairs Medical Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Deepak D'Souza, MD
role: PRINCIPAL_INVESTIGATOR
References: