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Completed

NCT Number: NCT02487381

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Central Institute of Mental Health

Mannheim, Baden-Wurttemberg, 68159, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

delta-9-tetrahydrocannabinol

Drug

Other names: Dronabinol

Cannabidiol

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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 outcomes

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

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Central Institute of Mental Health, Mannheim

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 1, 2015
Registry last updated
Aug 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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