Gene-Environment-Interaction: Influence of the COMT Genotype on the Effects of Different Cannabinoids

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02487381
• Other study ID #: GEI-TCP II
• Status: Completed
• Phase: Phase 1
• First received: June 29, 2015
• Last updated: August 13, 2015
• Start date: April 2015
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Central Institute of Mental Health, Mannheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGermany: Federal Opium Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Informed consent given by the subject

• Healthy young man (age between 18 and 45) insightful to the study (WST> 95)

• Right handedness

• At least one time consumption of Cannabis but less than 10 times/ per lifetime, no consumption of other psychotropic agents (despite coffee or nicotine), no alcohol abuse

• Negative drug-screening at the time of screening

• Body Mass Index between 18 and 30

Exclusion Criteria:

• Lack of accountability

• Participation in other interventional trials

• Severe medical or neurological illness, especially cardiovascular, renal, advanced respiratory, hematological or endocrinological failures or infectious diseases (acute hepatitis A, B or C or HIV) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, at the discretion of the investigator

• Any known psychiatric illness in the participant's history

• Known family history concerning psychiatric disorders

• Cannabis consumption within the last six months

• Consumption of any illegal drugs (except cannabis in history, see above)

• Intake of interfering medication, at the discretion of the investigator

• High intracranial pressure

• Any disorders in stereoscopic vision (measured by the TNO-Test, Lamerics, Utrecht) or hearing deficits

• Contraindications due to the Investigators Brochure Contraindication for Magnetic Resonance Imaging (e.g. cardiac pacemaker, claustrophobia, attached brace, in body metal, tattoos) or lumbar puncture (e.g. local or systemic infection, disturbance of blood coagulation, medication with anticoagulants like Phenprocoumon)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy
• Modeling Psychosis

Intervention

Drug:
• delta-9-tetrahydrocannabinol

• Cannabidiol

• Placebo

Locations

Country	Name	City	State
Germany	Central Institute of Mental Health	Mannheim	BW

Sponsors (1)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of biomarker profiles in serum and cerebrospinal fluid of subjects.		1 day	No
Primary	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.		up to 4 hours	No
Secondary	Change in Positive and Negative Syndrome Scale (PANSS) subscores and clusters (baseline to post drug intake)		up to 4 hours	No
Secondary	Change in neuropsychological parameters		up to 6 hours	No
Secondary	Assessment of hallucinogen states (APZ) (post drug intake)		1 day	No
Secondary	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		1 day	Yes
Secondary	Metabolic markers post drug intake (blood)		up to 4 hours	No
Secondary	Metabolic markers post drug intake (cerebrospinal fluid)		up to 4 hours	No
Secondary	Neural synchrony and event-related potentials post drug intake		up to 5 hours	No