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

Early Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Cannabidiol; Drug: Placebo; Drug: Delta-9-THC

• Registration Number: NCT01180374
• Lead Sponsor: Yale University

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 available

Study Timeline

• Study Start: 2010-02-01
• Study First Submitted: 2010-08-10
• Study First Submitted QC: 2010-08-10
• Study First Posted: 2010-08-12
• Primary Completion: 2014-10-06
• Study Completion: 2014-10-06
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Exposed to Cannabis at least once in lifetime

Exclusion Criteria

• Cannabis Naive

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active Cannabidiol and Placebo	Placebo	-
Placebo and Active Delta-9-THC	Placebo	-
Placebo and Placebo	Placebo	-
Active Canabidiol and Active Delta-9-THC	Cannabidiol	-
Active Canabidiol and Active Delta-9-THC	Delta-9-THC	-
Placebo and Active Delta-9-THC	Delta-9-THC	-
Active Cannabidiol and Placebo	Cannabidiol	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

VA Connecticut Healthcare System; 🇺🇸 West Haven, Connecticut, United States