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

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT01180374

Collaborator

(none)

Enrollment

Location

Arms

56.1

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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 Drug: Placebo	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

27 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

Actual Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Oct 6, 2014

Actual Study Completion Date :

Oct 6, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Behavioral Measures [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.