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

Central Institute of Mental Health, Mannheim

Status and phase: Completed; Phase 1

Conditions: Healthy; Modeling Psychosis

Treatments: Drug: Cannabidiol; Drug: delta-9-tetrahydrocannabinol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02487381

GEI-TCP II

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 4 patient groups, including a placebo group

THC

Experimental group

Description:

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

Treatment:

Drug: delta-9-tetrahydrocannabinol

Drug: Placebo

CBD

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Cannabidiol

CBD+THC

Experimental group

Description:

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

Treatment:

Drug: delta-9-tetrahydrocannabinol

Drug: Cannabidiol

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo