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

First Received on September 14, 2006. Last Updated on June 26, 2008 History of Changes

Sponsor:	Ludwig-Maximilians - University of Munich
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

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 II

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:

MedlinePlus related topics: Complex Regional Pain Syndrome

Drug Information available for: Tetrahydrocannabinol

U.S. FDA Resources

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

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:

Homepage of the German Research Network on Neuropathic Pain This link exits the ClinicalTrials.gov site

Publications:

Rolke R, Baron R, Maier C, Tolle TR, Treede RD, Beyer A, Binder A, Birbaumer N, Birklein F, Botefur IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihofner C, Rolko C, Schaub C, Scherens A, Sprenger T, Valet M, Wasserka B. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. 2006 Aug;123(3):231-43. Epub 2006 May 11.

Azad SC, Monory K, Marsicano G, Cravatt BF, Lutz B, Zieglgansberger W, Rammes G. Circuitry for associative plasticity in the amygdala involves endocannabinoid signaling. J Neurosci. 2004 Nov 3;24(44):9953-61.

Azad SC, Eder M, Marsicano G, Lutz B, Zieglgansberger W, Rammes G. Activation of the cannabinoid receptor type 1 decreases glutamatergic and GABAergic synaptic transmission in the lateral amygdala of the mouse. Learn Mem. 2003 Mar-Apr;10(2):116-28.

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:

Somatoform Disorders
Complex Regional Pain Syndromes
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 February 09, 2012