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| ID | Type | Description | Link |
|---|---|---|---|
| RO1 | Other Identifier | National Institute on Drug Abuse |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delta-9-THC Very Low Dose | Active Comparator | Active delta-9-THC administered intravenously over 20 minutes. |
|
| Placebo | Placebo Comparator | Control: small amount of alcohol administered intravenously (quarter teaspoon), with no delta-9-THC, over 20 minutes. |
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| Delta-9-THC Medium Dose | Active Comparator | Active delta-9-THC administered intravenously over 20 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delta-9-THC Very Low Dose | Drug | Active Delta-9-THC administered intravenously over 20 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
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Inclusion Criteria:
-Ages 21-60 years old
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deepak D'Souza, MD | Contact | 203-932-5711 | 12594 | deepak.douza@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Deepak D'Souza, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Haven Veterans Affairs Medical Center | Recruiting | West Haven | Connecticut | 06516 | United States |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Placebo | Drug | Control: Small amount of sterile 190 proof USP ethanol (1-2 mLs), with no THC, administered intravenously over 20 minutes. |
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| Delta-9-THC Medium Dose | Drug | Active Delta-9-THC administered intravenously over 20 minutes. |
|