Pharmacokinetics and Pharmacological Effects of a Standardized Cannabis Preparation
Condition: Cannabis Use; Healthy Subjects
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 1

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
    

Detailed description: 
      Medical cannabis" encompasses the use of cannabis and cannabinoids for therapeutic purposes.
      Includes drugs approved by regulatory agencies and pharmaceutical products. Recently, many
      countries have authorized the use of cannabis flower cups with a standardized amount of
      Δ9-tetrahydrocannabinol (THC), cannabidiol (CBD) and their acidic precursors
      (Δ-9-tetrahydrocannabinolic acid A [THCA] and cannabidiol acid [ CBDA]) for the treatment of
      different diseases. In Italy since January 2017 there has been for sale a standardized
      cannabis preparation produced by the Military Pharmaceutical Institute of Florence. This
      medicinal variety of cannabis sativa, known as FM2 has a variable THC and CBD percentage of
      between 5-8% and 7-12% respectively. To date, there are no studies on the pharmacokinetics of
      THC, CBD and other minor cannabinoids in conventional and unconventional biological matrices
      after oral administration of cannabis tea, cannabis oil and vaporized with the same medicinal
      preparation (FM2). The main objective is to know the concentrations of THC, CBD and
      metabolites, and other cannabinoids in blood, urine, oral fluid and sweat after the
      experimental administration of a standardized cannabis preparation orally (two formulations:
      cannabis tea and cannabis oil) and vaporized. In addition, the acute pharmacological effects
      and tolerability will be evaluated. Healthy recreational cannabis users with experience in
      oral use of cannabis will participate
    

Intervention name(s): Cannabis decoction; Cannabis oil; Vaporized cannabis
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single 100 mL dose of cannabis decoction is administered containing 1.8 mg THC and 2.7 mg CBD.; A single administration of 15 drops (045 mL) of cannabis oil containing 1.8 mg THC and 3.8 mg CBD.; 100mg of vaporized cannabis is administered by Volcano vaporizer, wich containing 0.6-2 mg THC and 0.8-3 mg CBD
Other intervention name(s): Cannabis tea; Inhaled cannabis
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The study was unicentric, open-label, not randomized, not placebo controlled ,single blind. The study included three substudies (one for each formulation administration). The first one for decoction administration, the second one for oil administration, and finally, an experimental session was held for the administration of the standardized vaporized cannabis preparation. Each subject will participate in one experimental session. One treatment condition per subject (of two possible oral formulations and one inhaled / vaporized formulation of vaporized cannabis. Once the experimental session is over, the subjects have the possibility of being able to participate in the same study after a minimum washout period of 3 weeks.
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: medical cannabis; pharmacokinetics; acute effects; cannabis decoction; cannabis oil; vaporized cannabis; oral cannabis