INTERVENTIONALCOMPLETEDNCT02487381

Gene-Environment-Interaction: Influence of the COMT Genotype on the Effects of Different Cannabinoids on the Endocannabinoid System, Cognition and Neuronal Oscillations

The study evaluates the gene-environment interaction of the COMT-genotype on the effects of the phytocannabinoids delta-9-tetrahydrocannabinol, cannabidiol or a combination of both on induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal processing, and neural oscillations. In addition the effects of the phytocannabinoids on lipid levels in serum and cerebrospinal fluid, cognition, neural synchrony and neuronal processing assessed by EEG and fMRI.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2015-08-17

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE1
Enrollment: 60 (ESTIMATED)
Start date: 2015-04
Sponsor: Central Institute of Mental Health, Mannheim
Design: RANDOMIZED · PARALLEL · BASIC SCIENCE
Locations: 1
Results record: Not present in registry snapshot

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

cannabidiol Delta(9)-tetrahydrocannabinol

Medicines

DRONABINOL DRONABINOL DRONABINOL DRONABINOL

Research network

Researchers and organizations

Cathrin Rohleder Martin Hellmich

Interventions

Gene-Environment-Interaction: Influence of the COMT Genotype on the Effects of Different Cannabinoids on the Endocannabinoid System, Cognition and Neuronal Oscillations

Protocol only - no registry results posted

Study at a glance

Related local records

Conditions

Cannabinoids and active compounds

Medicines

Researchers and organizations

What was registered

delta-9-tetrahydrocannabinol

Cannabidiol

Placebo

Population and criteria

Inclusion criteria

Exclusion criteria

primary measures

Change in Positive and Negative Syndrome Scale total score (PANSS T) from baseline to post drug intake of both on induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal processing, and neural synchrony.

secondary measures

Change in Positive and Negative Syndrome Scale (PANSS) subscores and clusters (baseline to post drug intake)

Change in neuropsychological parameters

Assessment of hallucinogen states (APZ) (post drug intake)

Safety and tolerability assessments including (S)AEs, physical examination, vital signs (including heart rate and systolic and diastolic blood pressure in both supine and standing positions), and detailed laboratory assessments

Metabolic markers post drug intake (blood)

Metabolic markers post drug intake (cerebrospinal fluid)

Neural synchrony and event-related potentials post drug intake

other measures

Assessment of biomarker profiles in serum and cerebrospinal fluid of subjects.

Locally readable linked articles

Effects of Cannabidiol and Delta-9-Tetrahydrocannabinol on Emotion, Cognition, and Attention: A Double-Blind, Placebo-Controlled, Randomized Experimental Trial in Healthy Volunteers.