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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

Tracking Information
First Submitted Date  ICMJE August 10, 2010
First Posted Date  ICMJE August 12, 2010
Last Update Posted Date January 31, 2022
Actual Study Start Date  ICMJE February 1, 2010
Actual Primary Completion Date October 6, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2010)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Cannabidiol and ∆-9-THC in Humans
Official Title  ICMJE Cannabidiol Modulation of ∆-9-THC's Psychotomimetic Effects in Healthy Humans
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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".
  • 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.
Study Arms  ICMJE
  • Experimental: Active Canabidiol and Active Delta-9-THC
    Interventions:
    • Drug: Cannabidiol
    • Drug: Delta-9-THC
  • Placebo Comparator: Placebo and Active Delta-9-THC
    Interventions:
    • Drug: Delta-9-THC
    • Drug: Placebo
  • Experimental: Active Cannabidiol and Placebo
    Interventions:
    • Drug: Cannabidiol
    • Drug: Placebo
  • Placebo Comparator: Placebo and Placebo
    Interventions:
    • Drug: Placebo
    • Drug: Placebo
Publications * 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. 2022 Mar 18. doi: 10.1089/can.2021.0166. Online ahead of print.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2022)		 27
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2010)		 36
Actual Study Completion Date  ICMJE October 6, 2014
Actual Primary Completion Date October 6, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Exposed to Cannabis at least once in lifetime

Exclusion Criteria:

  • Cannabis Naive
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01180374
Other Study ID Numbers  ICMJE 1001006240
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Mohini Ranganathan, Yale University
Original Responsible Party Mohini Ranganathan, M.D., Yale University School of Medicine, Dept of Psychiatry
Current Study Sponsor  ICMJE Yale University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohini Ranganathan, M.D Yale University Medical School
PRS Account Yale University
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP