Trial document




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  DRKS00005442

Trial Description

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Title

Modulaton of stress analgesia with tetrahydrocannabinol or cannabidiol

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Trial Acronym

LOGIN-TS4

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URL of the Trial

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Brief Summary in Lay Language

Healthy subjects are examined during a pain stimulus by functional magnetic resonance imaging. Before testing, they take once a placebo, tetrahydrocannabinol or cannabidiol. Each subject will be measured three times and therefore receives each drug one time.

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Brief Summary in Scientific Language

We are planning the implementation of a neuroscientific study using functional magnetic resonance imaging (fMRI) and pharmacological provocation in healthy subjects. The influence of a modulation of the endocannabinoid system on stress analgesia will be investigated. The pharmacological provocation test is done by a single dose of tetrahydrocannabinol (THC) and Cannabidiol (CBD) before testing. The drug application acts as provocation of a specific neuro-chemical processes in the brain, the strengthening or weakening of the endocannbinoid system.

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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

  •   DRKS00005442
  •   2013/11/28
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  •   yes
  •   Approved
  •   2013-009F-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

  •   2013-000596-33 
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Health Condition or Problem studied

  •   healthy volunteers
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Interventions/Observational Groups

  •   10 mg Tetrahydrocannabinol as oral capsule
  •   600 mg Cannabidiol as oral capsule
  •   Placebo capsule
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo, Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

fMRI signal dependent on drug measured during stress analgesia

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Secondary Outcome

subjective Painrating (Likert Scale 1-10, Manikin-Scale according to Bradley)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/02/07
  •   25
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   50   Years
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Additional Inclusion Criteria

age 18-50 years, right handed, male

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Exclusion Criteria

Cannabis use on life span > 5 times, other substance dependencies (except nicotine), other axis I disorders, epilepsy, chronic diseases (such as diabetes mellitus), hypersensitivity reactions, other diseases that are incompatible with the planned study procedure.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Zentralinstitut für Seelische Gesundheit
    • Ms.  Prof. Dr.  Herta  Flor 
    • J5
    • 68159  Mannheim
    • Germany
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    • ZI Mannheim
    • Mr.  Martin  Löffler 
    • J5
    • 68159  Mannheim
    • Germany
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    • ZI Mannheim
    • Mr.  Martin  Löffler 
    • J5
    • 68159  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/12/18
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Trial Publications, Results and other Documents

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