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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
  Purpose

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 Intervention Phase
Complex Regional Pain Syndromes
CRPS
Drug: Delta9-Tetrahydrocannabinol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 100
Study Start Date: September 2006
Estimated Study Completion Date: December 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00377468     History of Changes
Other Study ID Numbers: 2310106, Eudra-CT: 2006-000439-85
Study First Received: September 14, 2006
Last Updated: June 26, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Complex Regional Pain Syndromes
Somatoform Disorders
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Tetrahydrocannabinol
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 23, 2014