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

NCT ID: NCT01180374

Last Updated: 2022-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-01

Study Completion Date

2014-10-06

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active Canabidiol and Active Delta-9-THC

Group Type EXPERIMENTAL

Cannabidiol

Intervention Type DRUG

Active Cannabidiol 5mg.

Delta-9-THC

Intervention Type DRUG

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 and Active Delta-9-THC

Group Type PLACEBO_COMPARATOR

Delta-9-THC

Intervention Type DRUG

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

Intervention Type DRUG

Placebo (about a quarter spoon of alcohol with no CBD).

Active Cannabidiol and Placebo

Group Type EXPERIMENTAL

Cannabidiol

Intervention Type DRUG

Active Cannabidiol 5mg.

Placebo

Intervention Type DRUG

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

Placebo and Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (about a quarter spoon of alcohol with no CBD).

Placebo

Intervention Type DRUG

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

Interventions

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Cannabidiol

Active Cannabidiol 5mg.

Intervention Type 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".

Intervention Type DRUG

Placebo

Placebo (about a quarter spoon of alcohol with no CBD).

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Exposed to Cannabis at least once in lifetime

Exclusion Criteria

* Cannabis Naive
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Mohini Ranganathan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohini Ranganathan, M.D

Role: PRINCIPAL_INVESTIGATOR

Yale University Medical School

Locations

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VA Connecticut Healthcare System

West Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35319274 (View on PubMed)

Other Identifiers

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1001006240

Identifier Type: -

Identifier Source: org_study_id

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