Cannabis Use Disorder, Schizophrenia
Conditions
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.
Interventions
DRUGDelta-9-THC Very Low Dose
Active Delta-9-THC administered intravenously over 20 minutes.
DRUGPlacebo
Control: Small amount of sterile 190 proof USP ethanol (1-2 mLs), with no THC, administered intravenously over 20 minutes.
Active Delta-9-THC administered intravenously over 20 minutes.
Sponsors
Yale University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CogState Battery | 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. |
| Visual Analog Scale (VAS) | 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. |
| Positive and Negative Symptom Scale (PANSS) | 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. |
| Clinician Administered Dissociative Symptoms Scale (CADSS), | 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. |
Countries
United States
Contacts
CONTACTErik Zorrilla, PhD
CONTACTDeepak D'Spouza, MD
PRINCIPAL_INVESTIGATORDeepak D'Souza, MD
Yale University
Outcome results
None listed