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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01180374
Enrollment
27
Registered
2010-08-12
Start date
2010-02-01
Completion date
2014-10-06
Last updated
2022-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Cannabis, Marijuana, Cannabidiol, CBD, THC, Psychotic Disorders

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.

Interventions

DRUGCannabidiol

Active Cannabidiol 5mg.

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.

DRUGPlacebo

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

Sponsors

Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Exposed to Cannabis at least once in lifetime

Exclusion criteria

* Cannabis Naive

Design outcomes

Primary

MeasureTime frameDescription
Behavioral MeasuresBaseline, +15, +80, +240Subjective 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026