Cannabis Effects on Electroencephalography

Summary

Background:

Tetrahydrocannabinol (THC) is a partial CB1/CB2 agonist and causes its pharmacological effects by binding to cannabinoid receptors. CB1 receptors are predominantly located in the brain (highest densities at hippocampus, cerebellum and the striatum) and at low levels in the brainstem. CB2 receptors are predominantly in the spleen and in hematopoietic cells. THC is highly lipophilic and is readily absorbed and distributed to the brain and other organs.

Most of the neuropsychological studies carried out so far show that the mainly affected neurocognitive functions in cannabis users are: memory, attention, psychomotor capacity, speed of information processing and alterations of executive functions (resistance to interference, planning capacity, decision-making, verbal fluency and working memory). These effects are dose-dependent.

Hypothesis:

Functional CB1 receptor activation by the THC contained in the cannabis flos will induce dose-dependent effects on EEG, physiological functions and behavior:

1. EEG alterations.
2. Increase in cannabis subjective effects.
3. Increase in heart rate.
4. Increase in psychopathology scale Psychotomimetic State Inventory (PSI) score.
5. Increase in plasma cortisol concentrations.

Objectives:

Main pharmacodynamic objective: To assess the effects of Cannabis flos on electroencephalography (EEG) in healthy recreational cannabis users.

Secondary pharmacodynamic objectives: (i) To assess the effects of Cannabis flos on: cannabis subjective effects, heart rate and psychopathology scale; (ii) To establish the pharmacokinetic/pharmacodynamic relationships between THC plasma concentrations and pharmacodynamic endpoints.

Safety and tolerability objectives: To assess the safety and tolerability of THC in these subjects.

Methods:

Phase I, prospective, monocentric, double-blind, randomized, placebo-controlled, parallel group study to assess the THC effects on EEG neural oscillations in 16 healthy subjects with recreational cannabis use.

Conditions

• Healthy Volunteers

Interventions

DRUG

Cannabis Sativa

Subjects will receive a total of 4 inhaled doses of 20 mg of tetrahydrocannabinol (THC) in 3 days. Cannabis is provided as a medical grade cannabis flos (Cannabis sativa dried female flower) containing THC 22% and cannabidiol \<1%, supplied by Bedrocan®. To avoid the respiratory disadvantages of smoking, a vaporization device (Mighty® Medic) will be used to inhale the drug. The prepared capsules will contain 90 mg of Cannabis flos, equivalent to 20 mg of THC.

DRUG

Cannabis placebo

Subjects will receive a total of 4 inhaled doses of cannabis placebo (THC \<0,2%) in 3 days. Placebo cannabis is provided as a medical grade cannabis flos (Cannabis sativa dried female flower) containing cannabinoids \<0.2%. To avoid the respiratory disadvantages of smoking, a vaporization device (Mighty® Medic) will be used to inhale the drug. The prepared capsules will contain 90 mg of cannabis placebo.

Sponsors & Collaborators

• Parc de Salut Mar

  lead OTHER

Principal Investigators

• Rafael de la Torre Fornell, Dr · IMIM (Hospital del Mar Medical Research Institute)

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-03-03

Primary Completion

2020-07-09

Completion

2020-07-09

Countries

• Spain

Study Locations