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

NCT ID: NCT02492074

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2025-05-31

Brief 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, neuronal processing assessed by fMRI as well as D2-receptor availability assessed by [18F] desmethoxyfallypride.

Conditions

Healthy Volunteers; Modeling Psychosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

THC

Subjects receive 20 mg delta-9-tetrahydrocannabinol (2 capsules containing 10 mg each) and corresponding cannabidiol placebo capsules.

Group Type: EXPERIMENTAL

Delta-9-tetrahydrocannabinol

Intervention Type: DRUG

oral administration of delta-9-tetrahydrocannabinol

Placebo

Intervention Type: DRUG

oral administration of placebo

CBD

Subjects receive 800 mg cannabidiol (4 capsules containing 200 mg each) and corresponding delta-9-tetrahydrocannabinol placebo capsules.

Group Type: EXPERIMENTAL

Cannabidiol

Intervention Type: DRUG

oral administration of cannabidiol

Placebo

Intervention Type: DRUG

oral administration of placebo

CBD+THC

Subjects receive 800 mg cannabidiol (4 capsules containing 200 mg each) and 20 mg delta-9-tetrahydrocannabinol (2 capsules containing 10 mg each)

Group Type: EXPERIMENTAL

Delta-9-tetrahydrocannabinol

Intervention Type: DRUG

oral administration of delta-9-tetrahydrocannabinol

Cannabidiol

Intervention Type: DRUG

oral administration of cannabidiol

Placebo

Subjects receive corresponding delta-9-tetrahydrocannabinol and cannabidiol placebo capsules

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral administration of placebo

Interventions

Delta-9-tetrahydrocannabinol

oral administration of delta-9-tetrahydrocannabinol

Intervention Type: DRUG

Cannabidiol

oral administration of cannabidiol

Intervention Type: DRUG

Placebo

oral administration of placebo

Intervention Type: DRUG

Other Intervention Names

Dronabinol

Eligibility Criteria

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) or contradiction for the PET-CT method and the radiopharmaceutical

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

F. Markus Leweke, MD

Role: PRINCIPAL_INVESTIGATOR

Central Institute of Mental Health

Locations

Central Institute of Mental Health

Mannheim, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

GEI-TCP I

Identifier Type: -

Identifier Source: org_study_id