Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2026-02-21 @ 11:45 AM
Study NCT ID:
NCT00350532
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
2006-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clonidine-induced Spinal Acetylcholine Release: Normal Volunteers vs. Neuropathic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003000', 'term': 'Clonidine'}], 'ancestors': [{'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jimeisenach@gmail.com', 'phone': '336-716-4498', 'title': 'Dr. James Eisenach', 'organization': 'Wake Forest University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Neuropathic Pain Subjects', 'description': "Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.", 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy Subjects', 'description': "Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.", 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acetylcholine Concentration in Cerebrospinal Fluid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neuropathic Pain Subjects', 'description': "Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid."}, {'id': 'OG001', 'title': 'Healthy Subjects', 'description': "Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid."}], 'classes': [{'categories': [{'measurements': [{'value': '406', 'groupId': 'OG000', 'lowerLimit': '383', 'upperLimit': '406'}, {'value': '383', 'groupId': 'OG001', 'lowerLimit': '383', 'upperLimit': '406'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 minutes', 'description': 'Acetylcholine levels in CSF after administration of intrathecal clonidine measured by High-performance liquid chromatography (HPLC).', 'unitOfMeasure': 'picograms per milliliter (pg/ml)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'There was no difference noted in acetylcholine levels in healthy subjects compared to subjects with chronic pain'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Neuropathic Pain Subjects', 'description': "Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid."}, {'id': 'FG001', 'title': 'Healthy Subjects', 'description': "Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from 9/1/2004-6/2/2006. Subjects were recruited from a pain clinic and the control group were healthy subjects.', 'preAssignmentDetails': 'No significant events or abnormal approaches noted.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Neuropathic Pain Subjects', 'description': 'Subjects with existing neuropathic pain Outcome criterion is acetylcholine concentration in cerebrospinal fluid (CSF) at 60 minutes after injection.'}, {'id': 'BG001', 'title': 'Healthy Subjects', 'description': 'Healthy subjects with no existing pain conditions. Outcome criterion is acetylcholine concentration in cerebrospinal fluid (CSF) at 60 minutes after injection.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.875', 'spread': '11.48', 'groupId': 'BG000'}, {'value': '32', 'spread': '8.51', 'groupId': 'BG001'}, {'value': '40.86', 'spread': '12.91', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-10', 'studyFirstSubmitDate': '2006-07-05', 'resultsFirstSubmitDate': '2009-03-23', 'studyFirstSubmitQcDate': '2006-07-05', 'lastUpdatePostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-08-18', 'studyFirstPostDateStruct': {'date': '2006-07-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acetylcholine Concentration in Cerebrospinal Fluid', 'timeFrame': '60 minutes', 'description': 'Acetylcholine levels in CSF after administration of intrathecal clonidine measured by High-performance liquid chromatography (HPLC).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain, chronic pain', 'acetylcholine', 'clonidine', 'a2-adrenergic agonists', 'alpha2-adrenergic agonists'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the amount of acetylcholine release after a single injection of clonidine in normal volunteers and individuals with neuropathic pain.', 'detailedDescription': "This study is part of a pain center grant that focuses on how pain, especially chronic neuropathic pain, alters the response to traditional and non-traditional analgesics (pain medications).\n\nThe way that nerve fibers carry pain information to the brain is thought to change after surgery and in cases of chronic pain. For this reason, some medicines work better to relieve pain in healthy people who have a sudden painful injury when compared to people after surgery or to people with chronic pain. Currently available pain medications may not relieve all types of pain or may relieve pain only at doses that produce side effects and potential complications.\n\nThe aim of this study is to understand the mechanisms by which intrathecal clonidine (or clonidine injected into cerebrospinal fluid) increases in potency and efficacy by examining the cerebrospinal fluid of healthy individuals, before and after clonidine administration, as well as looking at the spinal fluid of people with chronic neuropathic nerve pain. More specifically, in this study, researchers will compare acetylcholine release (a protein-like substance found in cerebrospinal fluid) in normal volunteers and patients with neuropathic pain after a single injection of clonidine.\n\nAfter baseline measurements, including blood pressure and heart rate, participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.\n\nDuration of the study for participants is 1 day, and includes 1 visit to the research center, lasting approximately 3 hours."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult volunteers\n* Patients with neuropathic pain\n\nExclusion Criteria:\n\n* Pregnancy\n* Allergy to clonidine\n* Currently taking clonidine or other direct a2-adrenergic agonists\n* Taking cholinesterase inhibitors'}, 'identificationModule': {'nctId': 'NCT00350532', 'briefTitle': 'Clonidine-induced Spinal Acetylcholine Release: Normal Volunteers vs. Neuropathic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Clonidine-induced Spinal Acetylcholine Release: Normal Volunteers vs. Neuropathic Pain', 'orgStudyIdInfo': {'id': 'P01NS041386_TRIAL2'}, 'secondaryIdInfos': [{'id': 'P01NS041386', 'link': 'https://reporter.nih.gov/quickSearch/P01NS041386', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Neuropathic Pain Subjects', 'description': "Chronic Pain Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.", 'interventionNames': ['Drug: clonidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Subjects', 'description': "Healthy Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.", 'interventionNames': ['Drug: clonidine']}], 'interventions': [{'name': 'clonidine', 'type': 'DRUG', 'description': 'Patients will receive intrathecal clonidine (or clonidine injected into cerebrospinal fluid)', 'armGroupLabels': ['Neuropathic Pain Subjects']}, {'name': 'clonidine', 'type': 'DRUG', 'description': 'Patients will receive intrathecal clonidine (or clonidine injected into cerebrospinal fluid)', 'armGroupLabels': ['Healthy Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The Center for Clinical Research, 145 Kimel Park Drive', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '27157-1009', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University School of Medicine, Medical Center Boulevard', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'James C. Eisenach, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}, {'name': 'Richard Rauck, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Center for Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}