Genetic Basis of the Risk and Consequences of Cannabis Exposure in Humans
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-60
SponsorYale University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Delta-9-THC Very Low Dose
DrugActive Delta-9-THC administered intravenously over 20 minutes.
Placebo
DrugControl: Small amount of sterile 190 proof USP ethanol (1-2 mLs), with no THC, administered intravenously over 20 minutes.
Delta-9-THC Medium Dose
DrugActive Delta-9-THC administered intravenously over 20 minutes.
Treatment groups
215 Participants
are divided into 3 treatment groupsGroup A: Delta-9-THC Very Low DoseActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: Delta-9-THC Medium DoseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Visual Analog Scale (VAS)
The VAS is a scale to document perceived reward. A higher score reflects a positive response.
Time frame
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.2
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.
Time frame
Measured at baseline, 45 minutes, 90 minutes, 165 minutes, 210 minutes, and 360 minutes after the start of the initial THC/placebo drug infusion.3
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.
Time frame
Measured at baseline, 45 minutes, 90 minutes, 165 minutes, 210 minutes, and 360 minutes after the start of the initial THC/placebo drug infusion.4
CogState Battery
The CogState Battery measures cognition including verbal learning and recall and episodic memory.
Time frame
Measured at baseline, 45 minutes, and 165 minutes after the start of the initial THC/placebo drug infusion.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov