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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Ludwig-Maximilians - University of Munich.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
German Research Network on Neuropathic Pain
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00377468
First received: September 14, 2006
Last updated: June 26, 2008
Last verified: June 2008

September 14, 2006
June 26, 2008
September 2006
Not Provided
Incidence of chronic pain at one year assessed with Visual Analogue Scale (VAS)
Same as current
Complete list of historical versions of study NCT00377468 on ClinicalTrials.gov Archive Site
  • Changes in somatosensory phenotype at one year assessed with Quantitative Sensory Testing (QST)
  • Motor function of the affected extremity at one year assessed with a biometric evaluation
  • Changes in Health Related Quality of Life at one year assessed with SF-36
  • Changes in plasma endocannabinoid levels at 30, 60, 90 days and at one year
Same as current
Not Provided
Not Provided
 
Effect of Delta-9-Tetrahydrocannabinol on the Prevention of Chronic Pain in Patients With Acute CRPS (ETIC-Study)
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Complex Regional Pain Syndromes
  • CRPS
Drug: Delta9-Tetrahydrocannabinol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2008
Not Provided

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
Both
18 Years and older
No
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
Germany
 
NCT00377468
2310106, Eudra-CT: 2006-000439-85
Not Provided
Not Provided
Ludwig-Maximilians - University of Munich
  • German Federal Ministry of Education and Research
  • German Research Network on Neuropathic Pain
Principal Investigator: Shahnaz C Azad, MD;PhD Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, University of Munich
Ludwig-Maximilians - University of Munich
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP