Trial document
DRKS00000315
Trial Description
Title
Placebo controlled fMRT assessment
of the effects of the cannabinoid receptor agonist
dronabinol (THC) on pain associated brain activation
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.
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.
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
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- yes
- Approved
- 334/08, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
Secondary IDs
- U1111-1115-5572
- 2008-006881-27
- 4034806
Health Condition or Problem studied
- healthy volunteers
- R52.0 - Acute pain
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.
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
Secondary Outcome
Topographic distribution of the fMRI brain responses to nociceptive stimulation under dronabinol
Countries of Recruitment
- Germany
Locations of Recruitment
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Recruitment
- Actual
- 2010/07/01
- 36
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- 50 Years
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
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
Addresses
-
start of 1:1-Block address primary-sponsor
- Klinikum der J.W.Goethe-Universität Frankfurt
- Mr. Prof. Dr. Joseph Pfeilschifter
- Theodor-Stern-Kai 7
- 60590 Frankfurt
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- (0049) 69 / 6301 6951
- (0049) 69 / 6301 7942/7420
- Pfeilschifter at em.uni-frankfurt.de
- http://www.kgu.de/zpharm/allg/
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Institut für Klinische Pharmakologie Klinikum der J.W.Goethe-Universität Frankfurt
- Mr. Prof. Dr. Jörn Lötsch
- Theodor-Stern-Kai 7
- 60590 Frankfurt
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49-69-6301-7619
- +49-69-6301-7617
- j.loetsch at em.uni-frankfurt.de
- http://www.kgu.de/zpharm/klin/
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Institut für Klinische Pharmakologie Klinikum der J.W. Goethe-Universität Frankfurt
- Ms. Carmen Walter
- Theodor-Stern-Kai7
- 60590 Frankfurt
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 069-6301-87818
- +49-69-6301-7617
- walter at med.uni-frankfurt.de
- http://www.kgu.de/zpharm/klin/
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Deutsche Forschungsgemeinschaft e.V.
- Kennedyallee 40
- 53175 Bonn
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- +49 (228) 885-1
- +49 (228) 885-2777
- postmaster at dfg.de
- http://www.dfg.de/index.jsp
end of 1:1-Block address contact materialSupport -
start of 1:1-Block address otherSupport
- Institut für Klinische Pharmakologie Klinikum der J.W.Goethe-Universität Frankfurt
- Mr. Prof. Dr. Jörn Lötsch
- Theodor-Stern-Kai 7
- 60590 Frankfurt
- Germany
end of 1:1-Block address otherSupportstart of 1:1-Block address contact otherSupport- +49-69-6301-7619
- +49-69-6301-7617
- j.loetsch at em.uni-frankfurt.de
- http://www.kgu.de/zpharm/klin/
end of 1:1-Block address contact otherSupport
Status
- Recruiting complete, follow-up complete
- 2011/12/31
Trial Publications, Results and other Documents
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