Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:33 PM
Study NCT ID:
NCT00246532
Status:
COMPLETED
Last Update Posted:
2012-04-30
First Post:
2005-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Opiate-Induced Tolerance & Hyperalgesia in Pain Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-26', 'studyFirstSubmitDate': '2005-10-26', 'studyFirstSubmitQcDate': '2005-10-27', 'lastUpdatePostDateStruct': {'date': '2012-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Tolerance', 'timeFrame': '1 month'}, {'measure': 'Pain Threshold', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Opioid Titration', 'timeFrame': '1 month'}, {'measure': 'Pain Intensity', 'timeFrame': '1 month'}, {'measure': 'Roland-Morris Disability Index', 'timeFrame': '1 month'}, {'measure': 'Beck Depression Inventory', 'timeFrame': '1 month'}, {'measure': 'Follow-Up Survey', 'timeFrame': '1 year', 'description': 'Patients were asked about their average pain levels and current medication usage'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Low Back Pain', 'Opioid-induced Hyperalgesia']}, 'descriptionModule': {'briefSummary': 'Opiates such as morphine are the cornerstone medications for the treatment of moderate to severe pain. Recent evidence suggests that pain patients on chronic opioid therapy become more sensitive to pain (hyperalgesia) over time. There is also a long-standing notion that analgesic tolerance to opioids (habituation) develops during chronic use even though this phenomenon has never been prospectively studied. Our specific aims propose to prospectively test the hypotheses that; 1) Pain patients on chronic opioid therapy develop dose-dependent tolerance and/or hyperalgesia to these medications over time, 2) Opioid-induced tolerance and hyperalgesia develop differently with respect to various types of pain, 3) Opioid-induced hyperalgesia occurs independently of withdrawal phenomena, and 4) Opioid-induced tolerance and hyperalgesia develop differently based on gender and/or ethnicity. This proposed study will be the first quantitative and prospective study of tolerance and hyperalgesia in pain patients and will have important implications for the rational use of opioids in the treatment of chronic pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* opioid naïve (or less than 4 vicodin equiv/day)\n* 18-70 years old\n* candidate for opioid therapy for nonmalignant pain.\n\nExclusion Criteria:\n\n* history of substance abuse or severe psychiatric disease\n* use of medications for the treatment of neuropathic pain as these may alter tolerance or hyperalgesia\n* neurological conditions interfering with experimental pain testing, e.g. severe peripheral neuropathy'}, 'identificationModule': {'nctId': 'NCT00246532', 'briefTitle': 'Opiate-Induced Tolerance & Hyperalgesia in Pain Patients', 'organization': {'class': 'NIH', 'fullName': 'National Institute of General Medical Sciences (NIGMS)'}, 'officialTitle': 'Opiate-Induced Tolerance & Hyperalgesia in Pain Patients', 'orgStudyIdInfo': {'id': '5K23GM071400-02', 'link': 'https://reporter.nih.gov/quickSearch/5K23GM071400-02', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '5K23GM071400-02', 'link': 'https://reporter.nih.gov/quickSearch/5K23GM071400-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1: Placebo Pill', 'description': 'This arm contains placebo medication.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2: Morphine', 'description': 'Patients will receive oral morphine therapy.', 'interventionNames': ['Drug: Morphine']}], 'interventions': [{'name': 'Morphine', 'type': 'DRUG', 'description': 'Patients will be given morphine sulfate oral medication until their back pain is adequately controlled.', 'armGroupLabels': ['2: Morphine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Patients will receive placebo tablets.', 'armGroupLabels': ['1: Placebo Pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94025', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Lawrence F Chu, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'National Institute of General Medical Sciences', 'investigatorFullName': 'Dr. Lawrence Chu', 'investigatorAffiliation': 'Stanford University'}}}}