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

Complex Regional Pain Syndromes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00377468
• Other study ID #: 2310106
• Secondary ID: Eudra-CT: 2006-0
• Status: Recruiting
• Phase: Phase 2
• First received: September 14, 2006
• Last updated: June 26, 2008
• Start date: September 2006
• Est. completion date: December 2008

Study information

• Verified date: June 2008
• Source: Ludwig-Maximilians - University of Munich
• Contact: Meike Lauchart, MD
• Phone: +49897095
• Email: Meike.Lauchart[@]med.uni-muenchen.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Pain
• Complex Regional Pain Syndromes
• CRPS
• Reflex Sympathetic Dystrophy
• Somatoform Disorders

Intervention

Drug:
• Delta9-Tetrahydrocannabinol

Locations

Country	Name	City	State
Germany	Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, Universitiy of Munich	Munich

Sponsors (3)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	German Federal Ministry of Education and Research, German Research Network on Neuropathic Pain

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Azad SC, Eder M, Marsicano G, Lutz B, Zieglgänsberger 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. — View Citation

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

Rolke R, Baron R, Maier C, Tölle TR, Treede RD, Beyer A, Binder A, Birbaumer N, Birklein F, Bötefür IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihöfner 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. Erratum in: Pain. 2006 Nov;125(1-2):197. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of chronic pain at one year assessed with Visual Analogue Scale (VAS)
Secondary	Changes in somatosensory phenotype at one year assessed with Quantitative Sensory Testing (QST)
Secondary	Motor function of the affected extremity at one year assessed with a biometric evaluation
Secondary	Changes in Health Related Quality of Life at one year assessed with SF-36
Secondary	Changes in plasma endocannabinoid levels at 30, 60, 90 days and at one year

External Links

•   Homepage of the German Research Network on Neuropathic Pain