NCT00377468

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2006

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 30, 2008

Status Verified

June 1, 2008

First QC Date

September 14, 2006

Last Update Submit

June 26, 2008

Conditions

Complex Regional Pain SyndromesCRPS

Keywords

THCCRPSPainComplex Regional Pain SyndromeNeuropathic PainChronicPrevention

Outcome Measures

Primary Outcomes (1)

  • Incidence of chronic pain at one year assessed with Visual Analogue Scale (VAS)

Secondary Outcomes (4)

  • 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

Interventions

Delta9-TetrahydrocannabinolDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Munich, 81377, Germany

RECRUITING

Related Publications (3)

  • 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.

    PMID: 16697110BACKGROUND

  • 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.

    PMID: 15525780BACKGROUND

  • 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.

    PMID: 12663750BACKGROUND

MeSH Terms

Conditions

Complex Regional Pain SyndromesPainNeuralgiaBronchiolitis Obliterans Syndrome

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Shahnaz C Azad, MD;PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meike Lauchart, MD

CONTACT

+49897095Meike.Lauchart@med.uni-muenchen.de

Volker Huge, MD

CONTACT

+49897095Volker.Huge@med.uni-muenchen.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2006

First Posted

September 18, 2006

Study Start

September 1, 2006

Study Completion

December 1, 2008

Last Updated

June 30, 2008

Record last verified: 2008-06

Locations

DE(1)