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Trial record 98 of 191 for:    epidiolex

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

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ClinicalTrials.gov Identifier: NCT02492074
Recruitment Status : Not yet recruiting
First Posted : July 8, 2015
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
F Markus Leweke, Central Institute of Mental Health, Mannheim

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Modeling Psychosis Drug: Delta-9-tetrahydrocannabinol Drug: Cannabidiol Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Gene-Environment-Interaction: Influence of the COMT Genotype on the Effects of Different Cannabinoids on the Endocannabinoid System and Brain Function
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

Arm Intervention/treatment
Experimental: THC
Subjects receive 20 mg delta-9-tetrahydrocannabinol (2 capsules containing 10 mg each) and corresponding cannabidiol placebo capsules.
Drug: Delta-9-tetrahydrocannabinol
oral administration of delta-9-tetrahydrocannabinol
Other Name: Dronabinol

Drug: Placebo
oral administration of placebo

Experimental: CBD
Subjects receive 800 mg cannabidiol (4 capsules containing 200 mg each) and corresponding delta-9-tetrahydrocannabinol placebo capsules.
Drug: Cannabidiol
oral administration of cannabidiol

Drug: Placebo
oral administration of placebo

Experimental: 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)
Drug: Delta-9-tetrahydrocannabinol
oral administration of delta-9-tetrahydrocannabinol
Other Name: Dronabinol

Drug: Cannabidiol
oral administration of cannabidiol

Placebo Comparator: Placebo
Subjects receive corresponding delta-9-tetrahydrocannabinol and cannabidiol placebo capsules
Drug: Placebo
oral administration of placebo




Primary Outcome Measures :
  1. 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 D2-receptor availability [ Time Frame: up to 6 hours ]

Secondary Outcome Measures :
  1. Change in PANSS subscores and clusters (baseline to post drug intake) [ Time Frame: up to 4 hours ]
  2. Change in Digit Symbol Coding [ Time Frame: up to 6 hours ]
  3. Change in Letter-Number-Sequencing [ Time Frame: up to 6 hours ]
  4. Change in emotional state (EWL, "Eigenschaftswörterliste") [ Time Frame: up to 6 hours ]
  5. Change in attentional state (d2-test of attention d2-R) [ Time Frame: up to 6 hours ]
  6. Change in imagination (Bett's Questionaire upon Mental Imagery) [ Time Frame: up to 6 hours ]
  7. Change in binocular depth inversion illusion (BDII) [ Time Frame: up to 6 hours ]
  8. Change in Wisconsin Card Sorting Test Performance [ Time Frame: up to 6 hours ]
  9. Assessment of hallucinogenic states scale (APZ) (post drug intake) [ Time Frame: 1 day ]
    questionaire

  10. 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 [ Time Frame: 1 day ]
  11. Metabolic markers post drug intake (blood) [ Time Frame: up to 4 hours ]
  12. Metabolic markers post drug intake (cerebrospinal fluid) [ Time Frame: up to 4 hours ]
  13. D2-receptor availability post drug intake [ Time Frame: up to 5 hours ]

Other Outcome Measures:
  1. Assessment of biomarker profiles in serum and cerebrospinal fluid of subjects [ Time Frame: 1 day ]
    Comparison of biomarker profiles in serum and cerebrospinal fluid after different treatments



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02492074


Contacts
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Contact: F. Markus Leweke, MD +49 621 1703 2321 leweke@cimh.de
Contact: Cathrin Rohleder, PhD +49 621 1703 2333 rohleder@cimh.de

Locations
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Germany
Central Institute of Mental Health Not yet recruiting
Mannheim, BW, Germany, 68159
Contact: F. Markus Leweke, MD       leweke@cimh.de   
Sponsors and Collaborators
Central Institute of Mental Health, Mannheim

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Responsible Party: F Markus Leweke, Prof. Dr. F. Markus Leweke, Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier: NCT02492074     History of Changes
Other Study ID Numbers: GEI-TCP I
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by F Markus Leweke, Central Institute of Mental Health, Mannheim:
delta-9-tetrahydrocannabinol
cannabidiol
COMT

Additional relevant MeSH terms:
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Epidiolex
Dronabinol
Anticonvulsants
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists