Trial document




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  DRKS00000315

Trial Description

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Title

Placebo controlled fMRT assessment
of the effects of the cannabinoid receptor agonist
dronabinol (THC) on pain associated brain activation

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Dronabinol is the chemical designation for THC (tetrahydrocannabinol), one of the active components of the hemp plant (Cannabis sativa). Dronabinol is used for therapeutic purposes in anorexia due to severe chronic diseases, and for nausea and vomiting caused by chemotherapy. Another application of cannabis is the pain therapy.
We want to examine how Dronabinol acts on pain processing in the brain and compare this with its effects on the so-called reward system. For this purpose subjects will receive either dronabinol or placebo administered on two separate study days. To capture the effects of dronabinol on pain, an experimental pain model is used which is based on painful irritation of the nasal mucosa with gaseous carbon dioxide. In addition, to verify the effect of THC on the reward system, hydrogen sulphide and vanilla smell will be applied.

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Brief Summary in Scientific Language

Aim of this study is to investigate the effects of dronabinol on the activation of brain-areas responsible for the identification and quantification of pain stimuli and their affective-hedonic assessment . In a preliminary work the effects of opioids could be clearly differentiated in reducing the sensory or the affective component of pain. The thereby used imaging procedure fMRI should make this possible in the present study for THC.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00000315
  •   2010/06/22
  •   [---]*
  •   yes
  •   Approved
  •   334/08, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
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Secondary IDs

  •   U1111-1115-5572 
  •   2008-006881-27 
  •   4034806 
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Health Condition or Problem studied

  •   healthy volunteers
  •   R52.0 -  Acute pain
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Interventions/Observational Groups

  •   Study participants receive a single oral dose of 20mg tetrahydrocannabinol.
    Prior to administration of the study medication and 2 hours after administration a one hour-lasting MRI measurement for identification of brain areas activated by the pain and odor stimuli is conducted.
  •   Study participants receive a single oral dose of placebo.
    Prior to administration of the study medication and 2 hours after administration a one hour-lasting MRI measurement for identification of brain areas activated by the pain and odor stimuli is conducted.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Double or multiple blind
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  •   Placebo
  •   Other
  •   Crossover
  •   I
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Primary Outcome

Intensity of brain activation during nociceptive stimulation measured 2 hours after dronabinol application using functional magnetic resonance imaging

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Secondary Outcome

Topographic distribution of the fMRI brain responses to nociceptive stimulation under dronabinol

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2010/07/01
  •   36
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   50   Years
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Additional Inclusion Criteria

• Healthy men and women aged 18-50 years
• Body mass index (BMI) in the range of 18 kg/m2 and 30 kg/m2
• unremarkable medical history, especially no heart and circulatory diseases, mental medical history
• Healthy as determined by medical history, physical examination including vital signs and clinical laboratory test results
• Women of childbearing age must be sterile or postmenopausal or must apply two appropriate measures of contraception (e.g. oral hormonal contraceptive plus intrauterine device) in accordance with Note 3 of the Note for guidance on non-clinical studies saftey for the Conduct of human clinical trials for pharmaceuticals (CPMP / ICH / 286 / 95 modification) (double contraception).
• Signed informed consent after information about the benefits and risks of the trial and insurance

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Exclusion Criteria

• Participation in another clinical study within the last 30 days before study
• Simultaneous participation in another clinical trial
• History or current evidence of abuse of any drug substance, licit or illicit, including alcohol (urine drug screen)
• currently using of any prescription medication
• Hypersensitivity to the active substance or any of the other ingredients
• Epilepsy, a tendency to seizures
• Cardiovascular diseases
• Depression, bipolar disorder, schizophrenia and other psychiatric disorders in the medical history
• impaired liver function
• renal impairment
• Pregnancy (positive pregnancy test in urine at “screening” or at the beginning of the study) and breast-feeding
• Diseases or other criteria that make an MRI measurement impossible:
• Pacemakers
• neurostimulator or drug pump
• Metal parts in the body (e.g. chips, clips or staples after surgery, including: metal fragments in the body)
• claustrophobia

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Addresses

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    • Klinikum der J.W.Goethe-Universität Frankfurt
    • Mr.  Prof. Dr.  Joseph   Pfeilschifter 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
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    • Institut für Klinische Pharmakologie Klinikum der J.W.Goethe-Universität Frankfurt
    • Mr.  Prof. Dr.  Jörn  Lötsch 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
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    • Institut für Klinische Pharmakologie Klinikum der J.W. Goethe-Universität Frankfurt
    • Ms.  Carmen  Walter 
    • Theodor-Stern-Kai7
    • 60590  Frankfurt
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft e.V.
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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    • Institut für Klinische Pharmakologie Klinikum der J.W.Goethe-Universität Frankfurt
    • Mr.  Prof. Dr.  Jörn  Lötsch 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/12/31
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Trial Publications, Results and other Documents

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