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

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ClinicalTrials.gov Identifier: NCT01180374
Recruitment Status : Active, not recruiting
First Posted : August 12, 2010
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Mohini Ranganathan, Yale University

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 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 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
Study Start Date : June 2010
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

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.




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.



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

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
United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Mohini Ranganathan, M.D Yale University Medical School

Responsible Party: Mohini Ranganathan, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT01180374     History of Changes
Other Study ID Numbers: 1001006240
First Posted: August 12, 2010    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018

Keywords provided by Mohini Ranganathan, Yale University:
Cannabis
Marijuana
Cannabidiol
CBD
THC
Psychotic Disorders

Additional relevant MeSH terms:
Dronabinol
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