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NCT Number: NCT06058702

Genetic Basis of the Risk and Consequences of Cannabis Exposure in Humans

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.

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Key information

Conditions

Schizophrenia Cannabis Use Disorder Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

West Haven Veterans Affairs Medical Center

West Haven, Connecticut, 06516, United States

Location status: Recruiting

Location contact

Deepak C D'Souza, MD

CONTACT

[email protected]

203-932-5711 ext. 12594

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

    The VAS is a scale to document perceived reward. A higher score reflects a positive response.

  2. 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.

    The Positive and Negative Syndrome Scale is a 30-item scale to assess both the positive and negative symptom symptoms of schizophrenia. The range total score is 30-210. An improvement in symptoms is reflected by a lower score.

  3. 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.

    Perceptual alterations will be measured using scales such as the Clinician Administered Dissociative Symptoms Scale (CADSS), a scale consisting of 19 self-report items and 8 clinician-rated items (0 = not at all, 4 = extremely) that we have shown to be sensitive to THC effects. The scale captures alterations in environmental/time/body perception, feelings of unreality, and memory impairment.

  4. CogState Battery

    Time frame: Measured at baseline, 45 minutes, and 165 minutes after the start of the initial THC/placebo drug infusion.

    The CogState Battery measures cognition including verbal learning and recall and episodic memory.

Study contacts

Contact information is provided by the study sponsor or research team.

Deepak D'Souza, MD

CONTACT

[email protected]

203-932-5711 ext. 12594

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Sep 28, 2023
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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