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

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ClinicalTrials.gov Identifier: NCT02487381
Recruitment Status : Completed
First Posted : July 1, 2015
Last Update Posted : August 17, 2015
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, neural synchrony and neuronal processing assessed by EEG and fMRI.

Condition or disease Intervention/treatment Phase
Healthy 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, Cognition and Neuronal Oscillations
Study Start Date : April 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

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
Other Name: Dronabinol

Drug: Placebo
Experimental: CBD
Subjects receive 800 mg cannabidiol (4 capsules containing 200 mg each) and corresponding delta-9-tetrahydrocannabinol placebo capsules.
Drug: Cannabidiol
Drug: 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) a
Drug: delta-9-tetrahydrocannabinol
Other Name: Dronabinol

Drug: Cannabidiol
Placebo Comparator: Placebo
Subjects receive corresponding delta-9-tetrahydrocannabinol and cannabidiol placebo capsules
Drug: 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 neural synchrony. [ Time Frame: up to 4 hours ]

Secondary Outcome Measures :
  1. Change in Positive and Negative Syndrome Scale (PANSS) subscores and clusters (baseline to post drug intake) [ Time Frame: up to 4 hours ]
  2. Change in neuropsychological parameters [ Time Frame: up to 6 hours ]
  3. Assessment of hallucinogen states (APZ) (post drug intake) [ Time Frame: 1 day ]
  4. 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 ]
  5. Metabolic markers post drug intake (blood) [ Time Frame: up to 4 hours ]
  6. Metabolic markers post drug intake (cerebrospinal fluid) [ Time Frame: up to 4 hours ]
  7. Neural synchrony and event-related potentials 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 ]


Information from the National Library of Medicine

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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)

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): NCT02487381


Locations
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Germany
Central Institute of Mental Health
Mannheim, BW, Germany, 68159
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: NCT02487381     History of Changes
Other Study ID Numbers: GEI-TCP II
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: August 17, 2015
Last Verified: August 2015

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

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