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

January 19, 2022 updated by: Mohini Ranganathan, Yale University

Cannabidiol Modulation of ∆-9-THC's Psychotomimetic Effects in Healthy Humans

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • VA Connecticut Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Exposed to Cannabis at least once in lifetime

Exclusion Criteria:

  • Cannabis Naive

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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).
Drug: Placebo
Placebo (about a quarter spoon of alcohol with no THC) given intravenously over 20 minutes.
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".
Experimental: Active Cannabidiol and Placebo
Drug: Cannabidiol
Active Cannabidiol 5mg.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, +15, +80, +240

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Mohini Ranganathan, M.D, Yale University Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2010

Primary Completion (Actual)

October 6, 2014

Study Completion (Actual)

October 6, 2014

Study Registration Dates

First Submitted

August 10, 2010

First Submitted That Met QC Criteria

August 10, 2010

First Posted (Estimate)

August 12, 2010

Study Record Updates

Last Update Posted (Actual)

January 31, 2022

Last Update Submitted That Met QC Criteria

January 19, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1001006240

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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