Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-28 @ 5:45 PM
Study NCT ID:
NCT00377468
Status:
UNKNOWN
Last Update Posted:
2008-06-30
First Post:
2006-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Delta-9-Tetrahydrocannabinol on the Prevention of Chronic Pain in Patients With Acute CRPS (ETIC-Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020918', 'term': 'Complex Regional Pain Syndromes'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013759', 'term': 'Dronabinol'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-06-26', 'studyFirstSubmitDate': '2006-09-14', 'studyFirstSubmitQcDate': '2006-09-14', 'lastUpdatePostDateStruct': {'date': '2008-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of chronic pain at one year assessed with Visual Analogue Scale (VAS)'}], 'secondaryOutcomes': [{'measure': 'Changes in somatosensory phenotype at one year assessed with Quantitative Sensory Testing (QST)'}, {'measure': 'Motor function of the affected extremity at one year assessed with a biometric evaluation'}, {'measure': 'Changes in Health Related Quality of Life at one year assessed with SF-36'}, {'measure': 'Changes in plasma endocannabinoid levels at 30, 60, 90 days and at one year'}]}, 'conditionsModule': {'keywords': ['THC', 'CRPS', 'Pain', 'Complex Regional Pain Syndrome', 'Neuropathic Pain', 'Chronic', 'Prevention'], 'conditions': ['Complex Regional Pain Syndromes', 'CRPS']}, 'referencesModule': {'references': [{'pmid': '16697110', 'type': 'BACKGROUND', 'citation': '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': '15525780', 'type': 'BACKGROUND', 'citation': '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': '12663750', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nCRPS 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with clinical diagnosis of acute CRPS (time from inciting event less than 16 weeks) of the upper extremity\n* No risk of dependency in a psychological assessment\n\nExclusion Criteria:\n\n* History of alcohol or drug abuse\n* Cardiac arrhythmias\n* Acute or chronic renal failure\n* ASA physical status classification III or higher\n* Psychiatric disorders\n* Pregnancy and breast feeding'}, 'identificationModule': {'nctId': 'NCT00377468', 'briefTitle': 'Effect of Delta-9-Tetrahydrocannabinol on the Prevention of Chronic Pain in Patients With Acute CRPS (ETIC-Study)', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2310106'}, 'secondaryIdInfos': [{'id': 'Eudra-CT: 2006-000439-85'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Delta9-Tetrahydrocannabinol', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '81377', 'city': 'Munich', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, Universitiy of Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'centralContacts': [{'name': 'Meike Lauchart, MD', 'role': 'CONTACT', 'email': 'Meike.Lauchart@med.uni-muenchen.de', 'phone': '+49897095', 'phoneExt': '4464'}, {'name': 'Volker Huge, MD', 'role': 'CONTACT', 'email': 'Volker.Huge@med.uni-muenchen.de', 'phone': '+49897095', 'phoneExt': '4464'}], 'overallOfficials': [{'name': 'Shahnaz C Azad, MD;PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, University of Munich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}, {'name': 'German Research Network on Neuropathic Pain', 'class': 'NETWORK'}]}}}