Genetics of Cannabis Use Disorder and Cannabinoid Response in Humans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-16

Study Completion Date

2028-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Schizophrenia Cannabis Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Delta-9-THC Very Low Dose

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

Group Type ACTIVE_COMPARATOR

Delta-9-THC Very Low Dose

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Delta-9-THC Medium Dose

Intervention Type DRUG

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

Interventions

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Delta-9-THC Very Low Dose

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

Intervention Type DRUG

Placebo

Control: Small amount of sterile 190 proof USP ethanol (1-2 mLs), with no THC, administered intravenously over 20 minutes.

Intervention Type DRUG

Delta-9-THC Medium Dose

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes