Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-02-22 @ 7:04 AM
Study NCT ID:
NCT02252458
Status:
COMPLETED
Last Update Posted:
2015-01-09
First Post:
2014-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can Fentanyl Lead to Opioid-induced Hyperalgesia in Healthy Volunteers?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-08', 'studyFirstSubmitDate': '2014-09-08', 'studyFirstSubmitQcDate': '2014-09-29', 'lastUpdatePostDateStruct': {'date': '2015-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COMPOSITE of pain scores as measured by the nonverbal rating scale (NRS) at 15 minute intervals within the timeframe specified below.', 'timeFrame': '4.5 to 6.5h after begin of fentanyl infusion'}], 'secondaryOutcomes': [{'measure': 'Pain as measured by the nonverbal rating scale', 'timeFrame': '0-2h after begin of fentanyl infusion at 15 min intervals'}, {'measure': 'cold pressor pain', 'timeFrame': 'at -15min, 1h, 2h, 3h, 4h, 5h, 6h, 6h30min after begin of infusion'}, {'measure': 'Lab values (B-endorphin, fentanyl plasma Levels, potentially Adrenocorticotropic hormone (ACTH) / cortisol)', 'timeFrame': '-15min, -10min, -5 min, 0 min, 15 min, 30 min, 45min, 1h, 1h 30min, 2h, 4h 30min, 4h 35min, 4h 40min, 4h 45min, 5h, 5h 30min, 6h, 6h 30min after begin of infusion'}, {'measure': 'pupillary dilation response', 'timeFrame': 'baseline and at 4.5h after begin of infusion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Opioid induced hyperalgesia', 'Fentanyl'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '28106611', 'type': 'DERIVED', 'citation': 'Mauermann E, Blum CA, Lurati Buse G, Bandschapp O, Ruppen W. Time course of copeptin during a model of experimental pain and hyperalgesia: A randomised volunteer crossover trial. Eur J Anaesthesiol. 2017 May;34(5):306-314. doi: 10.1097/EJA.0000000000000592.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine whether two clinically sensible dose regimen of fentanyl (low dose vs. high dose) lead to different pain scores as measured by the nonverbal rating scale (NRS) in healthy volunteers at 4.5 to 6.5 hours after fentanyl application. Pain modalities tested will include transdermal electrical stimulation and cold pressor pain.\n\nThe investigators hypothesize that the high dose fentanyl group will have an increase of approximately 20% in the NRS.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy (ASA I-II) male volunteers\n* Age \\> 18 years\n* BMI 18 - 25 kg/m2\n\nExclusion Criteria:\n\n* Volunteers unable to give written informed consent\n* Known drug allergies or intolerance to fentanyl\n* Known drug allergies or intolerance to morphine and other opiates\n* Recreational drug addiction or abuse\n* Opiate use in the last month\n* Volunteers taking confounding medication (analgesics, antihistamines, calcium or potassium channel blockers) in the last month\n* History of motion sickness, neuropathy, chronic pain, neuromuscular or psychiatric disease\n* Patients with renal failure (clearance \\< 30 ml/min)\n* obstructive sleep apnea syndrome (OSAS)\n* Indication for Rapid Sequence Induction\n* Patients not understanding German, French, Italian or English'}, 'identificationModule': {'nctId': 'NCT02252458', 'acronym': 'FentaOIH-V', 'briefTitle': 'Can Fentanyl Lead to Opioid-induced Hyperalgesia in Healthy Volunteers?', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Can Fentanyl Lead to Opioid-induced Hyperalgesia in Healthy Volunteers? A Prospective, Randomized, Double-blinded Crossover Study', 'orgStudyIdInfo': {'id': '2014-054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fentanyl high dose', 'description': 'Fentanyl 10mcg/kg of bodyweight', 'interventionNames': ['Drug: Fentanyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fentanyl low dose', 'description': 'Fentanyl 1mcg/kg of bodyweight', 'interventionNames': ['Drug: Fentanyl']}], 'interventions': [{'name': 'Fentanyl', 'type': 'DRUG', 'armGroupLabels': ['Fentanyl high dose', 'Fentanyl low dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Department of Anesthesia, University of Basel Hospital', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Wilhelm Ruppen, PD Dr., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Basel, Dep. of Anesthesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}