NCT04316598: CEG

Cannabis Effects on Electroencephalography

Terminated Phase 1 Last updated 31 July 2020

What this trial tests

Phase 1 trial testing Cannabis Sativa in Healthy Volunteers in 16 participants. Terminated before completion.

Timeline

3 March 2020

Primary endpoint
9 July 2020

9 July 2020

Quick facts

Lead sponsor	Parc de Salut Mar
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	other
Enrollment	16
Start date	3 March 2020
Primary completion	9 July 2020
Estimated completion	9 July 2020
Sites	1 location across Spain

Drugs / interventions tested

• Cannabis Sativa — full drug profile →
• Cannabis placebo

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Parc de Salut Mar — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.