The Effects of Cannabidiol and ∆-9-THC in Humans
Cannabidiol Modulation of ∆-9-THC's Psychotomimetic Effects in Healthy Humans
1 other identifier
interventional
27
1 country
1
Brief Summary
Cannabis is the most commonly used illicit substance in the US and herbal cannabis consists of a number of cannabinoids including Δ-9 THC and CBD. This study will characterize the interactive effects of the two major components of cannabis i.e. Δ-9-THC and CBD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1 healthy
Started Feb 2010
Longer than P75 for early_phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 10, 2010
CompletedFirst Posted
Study publicly available on registry
August 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 6, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 6, 2014
CompletedJanuary 31, 2022
January 1, 2022
4.7 years
August 10, 2010
January 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Behavioral Measures
Subjective effects, perceptual alterations, and cognitive effects will be assessed using visual analog scales, Positive and Negative Symptom Subscale (PANSS), Clinician Administered Dissociative States Scale (CADSS), Psychotomimetic States Inventory (PSI) and a neuro cognitive battery.
Baseline, +15, +80, +240
Study Arms (4)
Active Canabidiol and Active Delta-9-THC
EXPERIMENTALPlacebo and Active Delta-9-THC
PLACEBO COMPARATORActive Cannabidiol and Placebo
EXPERIMENTALPlacebo and Placebo
PLACEBO COMPARATORInterventions
Active Cannabidiol 5mg.
Active Delta-9-THC (0.035mg/Kg) given intravenously over 20 minutes. The dose of THC that you may receive is a small dose and is roughly equivalent to smoking approximately one half to one whole marijuana cigarette, or "joint".
Placebo (about a quarter spoon of alcohol with no CBD).
Eligibility Criteria
You may qualify if:
- Exposed to Cannabis at least once in lifetime
You may not qualify if:
- Cannabis Naive
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
VA Connecticut Healthcare System
West Haven, Connecticut, 06516, United States
Related Publications (1)
Ganesh S, Cortes-Briones J, Schnakenberg Martin AM, Skosnik PD, D'Souza DC, Ranganathan M. Delta-9-Tetrahydrocannabinol, Cannabidiol, and Acute Psychotomimetic States: A Balancing Act of the Principal Phyto-Cannabinoids on Human Brain and Behavior. Cannabis Cannabinoid Res. 2023 Oct;8(5):846-856. doi: 10.1089/can.2021.0166. Epub 2022 Mar 18.
PMID: 35319274DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohini Ranganathan, M.D
Yale University Medical School
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 10, 2010
First Posted
August 12, 2010
Study Start
February 1, 2010
Primary Completion
October 6, 2014
Study Completion
October 6, 2014
Last Updated
January 31, 2022
Record last verified: 2022-01