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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
Est. primary completion date
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


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
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