Genetics of Cannabis Use Disorder and Cannabinoid Response in Humans

Schizophrenia Clinical Trial

Official title:

Genetics of Cannabis Use Disorder and Cannabinoid Response in Humans

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06058702
• Other study ID #: 2000036194
• Secondary ID: RO1
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: July 1, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: Deepak D'Souza, MD
• Phone: 203-932-5711
• Email: deepak.douza[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 215
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

-Ages 18-60 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

Related Conditions & MeSH terms

• Cannabis Use Disorder
• Marijuana Abuse
• Schizophrenia

Intervention

Drug:
• Delta-9-THC
Active Delta-9-THC (0.036 mg/kg) 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.

Locations

Country	Name	City	State
United States	West Haven Veterans Affairs Medical Center	West Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS)	The VAS is a scale to document perceived reward. A higher score reflects a positive response.	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.
Primary	Positive and Negative Symptom Scale (PANSS)	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.	Measured at baseline, 45 minutes, 90 minutes, 165 minutes, 210 minutes, and 360 minutes after the start of the initial THC/placebo drug infusion.
Primary	Clinician Administered Dissociative Symptoms Scale (CADSS),	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.	Measured at baseline, 45 minutes, 90 minutes, 165 minutes, 210 minutes, and 360 minutes after the start of the initial THC/placebo drug infusion.
Primary	CogState Battery	The CogState Battery measures cognition including verbal learning and recall and episodic memory.	Measured at baseline, 45 minutes, and 165 minutes after the start of the initial THC/placebo drug infusion.