Genetic Basis of Cannabis Exposure Risk and Consequences
This study is looking at how genetics might influence a person's risk for cannabis use disorder (CanUD) and psychosis, as well as how they respond to cannabis. Researchers will give participants either a very low dose or a medium dose of Delta-9-THC (the main active ingredient in cannabis) intravenously (into a vein), or a placebo (an inactive substance). They will then measure things like feelings, thoughts, and dissociative symptoms (feeling detached from reality) at various times after the infusion. The study aims to enroll 215 participants aged 21 to 60 years old. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 215 participants. It compares the effects of different doses of Delta-9-THC to a placebo.
- What's involved
- Participants will receive an intravenous infusion of either Delta-9-THC or a placebo over 20 minutes. Measurements will be taken at several time points up to 360 minutes (6 hours) after the infusion starts.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 360 minutes (6 hours) after the start of the initial drug infusion.
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Genetic Basis of the Risk and Consequences of Cannabis Exposure in Humans
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Deepak D'Souza, MD · PRINCIPAL_INVESTIGATOR · Yale University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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.
- CogState BatteryMeasured 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.