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Effect of Delta-9-Tetrahydrocannabinol on the Prevention of Chronic Pain in Patients With Acute CRPS (ETIC-Study)

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ClinicalTrials.gov Identifier: NCT00377468
Recruitment Status : Unknown
Verified June 2008 by Ludwig-Maximilians - University of Munich.
Recruitment status was:  Recruiting
First Posted : September 18, 2006
Last Update Posted : June 30, 2008
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
German Research Network on Neuropathic Pain
Information provided by:
Ludwig-Maximilians - University of Munich

Brief Summary:
The purpose of this study is to determine whether application of low dose Delta9-Tetrahydrocannabinol can prevent the development of chronic pain in patients with acute CRPS.

Condition or disease Intervention/treatment Phase
Complex Regional Pain Syndromes CRPS Drug: Delta9-Tetrahydrocannabinol Phase 2

Detailed Description:

Recent animal data suggest that the endocannabinoid system is a promising target in the prevention of chronic pain. It has been shown that the endocannabinoid system modifies excitatory and inhibitory currents in structures involved in the development of chronic pain such as the amygdala.

CRPS is a neuropathic pain condition, which is known to become chronic in a significant percentage. The study compares the effect of low dose Delta9-Tetrahydrocannabinol (90 days) and placebo in acute CRPS. All patients will receive a standard treatment consisting of drug therapy and physiotherapy.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Low Dose Administration of Delta9-Tetrahydrocannabinol for the Prevention of Hyperalgesia and Chronic Pain in Patients With Acute Complex Regional Pain Syndrome (CRPS) of the Upper Limb
Study Start Date : September 2006
Estimated Study Completion Date : December 2008





Primary Outcome Measures :
  1. Incidence of chronic pain at one year assessed with Visual Analogue Scale (VAS)

Secondary Outcome Measures :
  1. Changes in somatosensory phenotype at one year assessed with Quantitative Sensory Testing (QST)
  2. Motor function of the affected extremity at one year assessed with a biometric evaluation
  3. Changes in Health Related Quality of Life at one year assessed with SF-36
  4. Changes in plasma endocannabinoid levels at 30, 60, 90 days and at one year


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with clinical diagnosis of acute CRPS (time from inciting event less than 16 weeks) of the upper extremity
  • No risk of dependency in a psychological assessment

Exclusion Criteria:

  • History of alcohol or drug abuse
  • Cardiac arrhythmias
  • Acute or chronic renal failure
  • ASA physical status classification III or higher
  • Psychiatric disorders
  • Pregnancy and breast feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377468


Contacts
Contact: Meike Lauchart, MD +49897095 ext 4464 Meike.Lauchart@med.uni-muenchen.de
Contact: Volker Huge, MD +49897095 ext 4464 Volker.Huge@med.uni-muenchen.de

Locations
Germany
Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, Universitiy of Munich Recruiting
Munich, Germany, 81377
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
German Federal Ministry of Education and Research
German Research Network on Neuropathic Pain
Investigators
Principal Investigator: Shahnaz C Azad, MD;PhD Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, University of Munich

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00377468     History of Changes
Other Study ID Numbers: 2310106
Eudra-CT: 2006-000439-85
First Posted: September 18, 2006    Key Record Dates
Last Update Posted: June 30, 2008
Last Verified: June 2008

Keywords provided by Ludwig-Maximilians - University of Munich:
THC
CRPS
Pain
Complex Regional Pain Syndrome
Neuropathic Pain
Chronic
Prevention

Additional relevant MeSH terms:
Syndrome
Chronic Pain
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Pain
Somatoform Disorders
Disease
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders
Autonomic Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists