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

Primary Purpose

Healthy, Modeling Psychosis

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

delta-9-tetrahydrocannabinol

Cannabidiol

Placebo

About this trial

This is an interventional basic science trial for Healthy focused on measuring delta-9-tetrahydrocannabinol, cannabidiol, COMT, Volunteers

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts 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)

Sites / Locations

Central Institute of Mental Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

THC

CBD

CBD+THC

Placebo

Arm Description

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

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

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

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

Outcomes

Primary Outcome 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 Outcome 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

Full Information

NCT ID

NCT02487381

First Posted

June 29, 2015

Last Updated

August 13, 2015

Sponsor

Central Institute of Mental Health, Mannheim

1. Study Identification

Unique Protocol Identification Number

NCT02487381

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

April 2015 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Central Institute of Mental Health, Mannheim

4. Oversight

Data Monitoring Committee

5. Study Description

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, neural synchrony and neuronal processing assessed by EEG and fMRI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Modeling Psychosis

Keywords

delta-9-tetrahydrocannabinol, cannabidiol, COMT, Volunteers

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

THC

Arm Type

Experimental

Arm Description

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

Arm Title

CBD

Arm Type

Experimental

Arm Description

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

Arm Title

CBD+THC

Arm Type

Experimental

Arm 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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

delta-9-tetrahydrocannabinol

Other Intervention Name(s)

Dronabinol

Intervention Type

Drug

Intervention Name(s)

Cannabidiol

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Time Frame

up to 4 hours

Secondary Outcome Measure Information:

Title

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

Time Frame

up to 4 hours

Title

Change in neuropsychological parameters

Time Frame

up to 6 hours

Title

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

Time Frame

1 day

Title

Time Frame

1 day

Title

Metabolic markers post drug intake (blood)

Time Frame

up to 4 hours

Title

Metabolic markers post drug intake (cerebrospinal fluid)

Time Frame

up to 4 hours

Title

Neural synchrony and event-related potentials post drug intake

Time Frame

up to 5 hours

Other Pre-specified Outcome Measures:

Title

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

Time Frame

1 day

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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)

Facility Information:

Facility Name

Central Institute of Mental Health

City

Mannheim

State/Province

ZIP/Postal Code

68159

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

33304282

Citation

Woelfl T, Rohleder C, Mueller JK, Lange B, Reuter A, Schmidt AM, Koethe D, Hellmich M, Leweke FM. Effects of Cannabidiol and Delta-9-Tetrahydrocannabinol on Emotion, Cognition, and Attention: A Double-Blind, Placebo-Controlled, Randomized Experimental Trial in Healthy Volunteers. Front Psychiatry. 2020 Nov 13;11:576877. doi: 10.3389/fpsyt.2020.576877. eCollection 2020.

Results Reference

derived

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

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