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The Effects of Cannabidiol and ∆-9-THC in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01180374
Recruitment Status : Completed
First Posted : August 12, 2010
Last Update Posted : January 31, 2022
Sponsor:
Information provided by (Responsible Party):
Mohini Ranganathan, Yale University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Cannabidiol Drug: Delta-9-THC Drug: Placebo Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Cannabidiol Modulation of ∆-9-THC's Psychotomimetic Effects in Healthy Humans
Actual Study Start Date : February 1, 2010
Actual Primary Completion Date : October 6, 2014
Actual Study Completion Date : October 6, 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

Arms and Interventions
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Arm Intervention/treatment
Experimental: Active Canabidiol and Active Delta-9-THC Drug: Cannabidiol
Active Cannabidiol 5mg.

Drug: Delta-9-THC
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 Comparator: Placebo and Active Delta-9-THC Drug: Delta-9-THC
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".

Drug: Placebo
Placebo (about a quarter spoon of alcohol with no CBD).
Experimental: Active Cannabidiol and Placebo Drug: Cannabidiol
Active Cannabidiol 5mg.

Drug: Placebo
Placebo (about a quarter spoon of alcohol with no THC) given intravenously over 20 minutes.
Placebo Comparator: Placebo and Placebo Drug: Placebo
Placebo (about a quarter spoon of alcohol with no CBD).

Drug: Placebo
Placebo (about a quarter spoon of alcohol with no THC) given intravenously over 20 minutes.


Outcome Measures
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Primary Outcome Measures :
  1. Behavioral Measures [ Time Frame: Baseline, +15, +80, +240 ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Exposed to Cannabis at least once in lifetime

Exclusion Criteria:

  • Cannabis Naive
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180374


Locations
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United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Mohini Ranganathan, M.D Yale University Medical School
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mohini Ranganathan, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT01180374    
Other Study ID Numbers: 1001006240
First Posted: August 12, 2010    Key Record Dates
Last Update Posted: January 31, 2022
Last Verified: January 2022
Keywords provided by Mohini Ranganathan, Yale University:
Cannabis
Marijuana
Cannabidiol
 CBD
THC
Psychotic Disorders
Additional relevant MeSH terms:
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Dronabinol
Cannabidiol
Anticonvulsants
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists