Overview

This trial is active, not recruiting.

Condition healthy
Treatments cannabidiol, delta-9-thc, placebo
Phase phase 1
Sponsor Yale University
Start date June 2010
End date July 2017
Trial size 75 participants
Trial identifier NCT01180374, 1001006240

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Experimental)
cannabidiol
Active Cannabidiol 5mg.
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)
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
Placebo (about a quarter spoon of alcohol with no CBD).
(Experimental)
cannabidiol
Active Cannabidiol 5mg.
placebo
Placebo (about a quarter spoon of alcohol with no THC) given intravenously over 20 minutes.
(Placebo Comparator)
placebo
Placebo (about a quarter spoon of alcohol with no CBD).
placebo
Placebo (about a quarter spoon of alcohol with no THC) given intravenously over 20 minutes.

Primary Outcomes

Measure
Behavioral Measures
time frame: Baseline, +15, +80, +240

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - Exposed to Cannabis at least once in lifetime Exclusion Criteria: - Cannabis Naive

Additional Information

Official title Cannabidiol Modulation of ∆-9-THC's Psychotomimetic Effects in Healthy Humans
Principal investigator Mohini Ranganathan, M.D
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Yale University.