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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 : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
F Markus Leweke, Central Institute of Mental Health, Mannheim

Tracking Information
First Submitted Date  ICMJE July 3, 2015
First Posted Date  ICMJE July 8, 2015
Last Update Posted Date August 14, 2019
Estimated Study Start Date  ICMJE June 2020
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02492074 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2018)
  • Change in PANSS subscores and clusters (baseline to post drug intake) [ Time Frame: up to 4 hours ]
  • Change in Digit Symbol Coding [ Time Frame: up to 6 hours ]
  • Change in Letter-Number-Sequencing [ Time Frame: up to 6 hours ]
  • Change in emotional state (EWL, "Eigenschaftswörterliste") [ Time Frame: up to 6 hours ]
  • Change in attentional state (d2-test of attention d2-R) [ Time Frame: up to 6 hours ]
  • Change in imagination (Bett's Questionaire upon Mental Imagery) [ Time Frame: up to 6 hours ]
  • Change in binocular depth inversion illusion (BDII) [ Time Frame: up to 6 hours ]
  • Change in Wisconsin Card Sorting Test Performance [ Time Frame: up to 6 hours ]
  • Assessment of hallucinogenic states scale (APZ) (post drug intake) [ Time Frame: 1 day ]
    questionaire
  • 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 ]
  • Metabolic markers post drug intake (blood) [ Time Frame: up to 4 hours ]
  • Metabolic markers post drug intake (cerebrospinal fluid) [ Time Frame: up to 4 hours ]
  • D2-receptor availability post drug intake [ Time Frame: up to 5 hours ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2015)
  • Change in PANSS subscores and clusters (baseline to post drug intake) [ Time Frame: up to 4 hours ]
  • Change in neuropsychological parameters [ Time Frame: up to 6 hours ]
  • Assessment of hallucinogen states (APZ) (post drug intake) [ Time Frame: 1 day ]
  • 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 ]
  • Metabolic markers post drug intake (blood) [ Time Frame: up to 4 hours ]
  • Metabolic markers post drug intake (cerebrospinal fluid) [ Time Frame: up to 4 hours ]
  • D2-receptor availability post drug intake [ Time Frame: up to 5 hours ]
Current Other Pre-specified Outcome Measures
 (submitted: March 13, 2018)
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
Original Other Pre-specified Outcome Measures
 (submitted: July 3, 2015)
Assessment of biomarker profiles in serum and cerebrospinal fluid of subjects [ Time Frame: 1 day ]
 
Descriptive Information
Brief Title  ICMJE Gene-Environment-Interaction: Influence of the COMT Genotype on the Effects of Different Cannabinoids - a PET Study
Official Title  ICMJE Gene-Environment-Interaction: Influence of the COMT Genotype on the Effects of Different Cannabinoids on the Endocannabinoid System and Brain Function
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Healthy Volunteers
  • Modeling Psychosis
Intervention  ICMJE
  • Drug: Delta-9-tetrahydrocannabinol
    oral administration of delta-9-tetrahydrocannabinol
    Other Name: Dronabinol
  • Drug: Cannabidiol
    oral administration of cannabidiol
  • Drug: Placebo
    oral administration of placebo
Study Arms  ICMJE
  • Experimental: THC
    Subjects receive 20 mg delta-9-tetrahydrocannabinol (2 capsules containing 10 mg each) and corresponding cannabidiol placebo capsules.
    Interventions:
    • Drug: Delta-9-tetrahydrocannabinol
    • Drug: Placebo
  • Experimental: CBD
    Subjects receive 800 mg cannabidiol (4 capsules containing 200 mg each) and corresponding delta-9-tetrahydrocannabinol placebo capsules.
    Interventions:
    • 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)
    Interventions:
    • Drug: Delta-9-tetrahydrocannabinol
    • Drug: Cannabidiol
  • Placebo Comparator: Placebo
    Subjects receive corresponding delta-9-tetrahydrocannabinol and cannabidiol placebo capsules
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 3, 2015)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: F. Markus Leweke, MD +49 621 1703 2321 leweke@cimh.de
Contact: Cathrin Rohleder, PhD +49 621 1703 2333 rohleder@cimh.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02492074
Other Study ID Numbers  ICMJE GEI-TCP I
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party F Markus Leweke, Central Institute of Mental Health, Mannheim
Study Sponsor  ICMJE Central Institute of Mental Health, Mannheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Central Institute of Mental Health, Mannheim
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP