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

Condition(s) targeted: Complex Regional Pain Syndromes; CRPS

Intervention: Delta9-Tetrahydrocannabinol (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Ludwig-Maximilians - University of Munich

Official(s) and/or principal investigator(s):
Shahnaz C Azad, MD;PhD, Principal Investigator, Affiliation: Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, University of Munich

Overall contact:
Meike Lauchart, MD, Phone: +49897095, Ext: 4464, Email: Meike.Lauchart@med.uni-muenchen.de

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.

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 design: Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study

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

Secondary outcome:

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

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Meike Lauchart, MD, Phone: +49897095, Ext: 4464, Email: Meike.Lauchart@med.uni-muenchen.de

Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, Universitiy of Munich, Munich 81377, Germany; Recruiting

Homepage of the German Research Network on Neuropathic Pain

Homepage of the research group

Related 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.

Starting date: September 2006
Ending date: December 2008
Last updated: June 26, 2008