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OpenTrials
Completed

NCT Number: NCT01180374

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

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Key information

Conditions

Healthy Chemically-Induced Disorders Marijuana Abuse Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Exposed to Cannabis at least once in lifetime

Exclusion criteria

  • Cannabis Naive

Treatment and study plan

Cannabidiol

Drug

Active Cannabidiol 5mg.

Delta-9-THC

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

Drug

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 12, 2010
Registry last updated
Jan 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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