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

NCT ID: NCT00377468

Last Updated: 2008-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Complex Regional Pain Syndromes CRPS

Keywords

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THC CRPS Pain Complex Regional Pain Syndrome Neuropathic Pain Chronic Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Delta9-Tetrahydrocannabinol

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

German Research Network on Neuropathic Pain

NETWORK

Sponsor Role collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Principal Investigators

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Shahnaz C Azad, MD;PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, University of Munich

Locations

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Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, Universitiy of Munich

Munich, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Meike Lauchart, MD

Role: CONTACT

Phone: +49897095

Email: [email protected]

Volker Huge, MD

Role: CONTACT

Phone: +49897095

Email: [email protected]

References

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Rolke R, Baron R, Maier C, Tolle TR, Treede -DR, 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):231-243. doi: 10.1016/j.pain.2006.01.041. Epub 2006 May 11.

Reference Type BACKGROUND
PMID: 16697110 (View on PubMed)

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. doi: 10.1523/JNEUROSCI.2134-04.2004.

Reference Type BACKGROUND
PMID: 15525780 (View on PubMed)

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. doi: 10.1101/lm.53303.

Reference Type BACKGROUND
PMID: 12663750 (View on PubMed)

Other Identifiers

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Eudra-CT: 2006-000439-85

Identifier Type: -

Identifier Source: secondary_id

2310106

Identifier Type: -

Identifier Source: org_study_id