Recruiting
Phase 1

Genetics of Cannabis

Sponsor:

Yale University

Code:

NCT06058702

Conditions

Schizophrenia

Cannabis Use Disorder

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Accepted

Interventions

Delta-9-THC Very Low Dose

Placebo

Delta-9-THC Medium Dose

Study Details

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.

Conditions

Schizophrenia

Cannabis Use Disorder

Study ID

NCT06058702

Start date

Sep 16, 2024

Status verified date

Sep, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Accepted

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

Enrollment

215 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

Delta-9-THC Very Low Dose

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

Placebo

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

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. ]
  • Positive and Negative Symptom Scale (PANSS) [ Time Frame: Measured at baseline, 45 minutes, 90 minutes, 165 minutes, 210 minutes, and 360 minutes after the start of the initial THC/placebo drug infusion. ]
  • Clinician Administered Dissociative Symptoms Scale (CADSS), [ Time Frame: Measured at baseline, 45 minutes, 90 minutes, 165 minutes, 210 minutes, and 360 minutes after the start of the initial THC/placebo drug infusion. ]
  • CogState Battery [ Time Frame: Measured at baseline, 45 minutes, and 165 minutes after the start of the initial THC/placebo drug infusion. ]

Central Contacts and Locations

Central contacts

Erik Zorrilla, PhD

203-932-5711erik.zorrilla@yale.edu

Deepak D'Spouza, MD

203-932-5711deepak.douza@yale.edu

Locations

West Haven Veterans Affairs Medical Center

Recruiting

West Haven, Connecticut, United States, 06516

Contacts

Deepak C D'Souza, MD

2039325711deepak.dsouza@yale.edu

More Information

Sponsor

Yale University

Last update posted

Sep 2, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Yale University on 2026-09-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.