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Pharmacokinetics and Pharmacological Effects of a Standardized Cannabis Preparation

NCT04841993 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2021-04-12

No results posted yet for this study

Summary

The purposes of the study are 1) to know the concentrations of Δ9-tetrahydrocannabinol (THC), cannabidiol (CBD) and other cannabinoids in blood, urine, oral fluid and sweat after the experimental administration of a standardized cannabis preparation orally (decoction and oil) and vaporized 2) to evaluate the pharmacological acute effects and tolerability

Conditions

  • Cannabis Use
  • Healthy Subjects

Interventions

DRUG

Cannabis decoction

A single 100 mL dose of cannabis decoction is administered containing 1.8 mg THC and 2.7 mg CBD.

DRUG

Cannabis oil

A single administration of 15 drops (045 mL) of cannabis oil containing 1.8 mg THC and 3.8 mg CBD.

DRUG

Vaporized cannabis

100mg of vaporized cannabis is administered by Volcano vaporizer, wich containing 0.6-2 mg THC and 0.8-3 mg CBD

Sponsors & Collaborators

  • Fundació Institut Germans Trias i Pujol

    collaborator OTHER

  • Istituto Superiore di Sanità

    collaborator OTHER

  • Germans Trias i Pujol Hospital

    lead OTHER

Principal Investigators

  • Magi Farré, MD, PhD · Germans Trias i Pujol Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-10
Primary Completion
2019-12-18
Completion
2021-02-28

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04841993 on ClinicalTrials.gov