Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2026-02-18 @ 3:04 AM
Study NCT ID:
NCT01210066
Status:
TERMINATED
Last Update Posted:
2016-12-29
First Post:
2010-09-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain, Opioids and Pro-Inflammatory Immune Responses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D000701', 'term': 'Analgesics, Opioid'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009294', 'term': 'Narcotics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'whyStopped': 'Unable to recruit prescription opioid abusers; ultimately no potential POA recruit passed the pre-screening process', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-27', 'studyFirstSubmitDate': '2010-09-27', 'studyFirstSubmitQcDate': '2010-09-27', 'lastUpdatePostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plasma levels of pro-inflammatory cytokine IL-6', 'timeFrame': '15 minutes prior to fentanyl administration, 60 and 180 minutes post fentanyl administration,', 'description': 'inflammatory cytokine activity will be evaluated with an in vivo approach over a three hour period of time to enable observation of the duration of opioid activity'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['inflammation', 'opioid-induced hyperalgesia', 'bupenorphine', 'prescription opioid abuse'], 'conditions': ['Pro-inflammatory Activity', 'Immunologic Activity Alteration']}, 'referencesModule': {'references': [{'pmid': '25901477', 'type': 'RESULT', 'citation': 'Compton P, Griffis C, Breen EC, Torrington M, Sadakane R, Tefera E, Irwin MR. Opioid treatment of experimental pain activates nuclear factor-kappaB. J Opioid Manag. 2015 Mar-Apr;11(2):115-25. doi: 10.5055/jom.2015.0261.'}]}, 'descriptionModule': {'briefSummary': 'Providing pain management to the patient who abuses prescription opioids presents a clinical challenge, not only due to concerns about "drug-seeking", but because they have increased sensitivity to pain, a phenomenon identified as opioid-induced hyperalgesia (OIH). In an effort to improve pain treatment, the aims of the proposed work are to evaluate the analgesic and hyperalgesic effects of opioids to acute pain in this vulnerable population, and to examine the role of opioid-induced proinflammatory changes in these responses.', 'detailedDescription': 'Both acute pain and opioid administration have been shown to induce a systemic pro-inflammatory response. However, the presence of these inflammatory responses is unknown in situations where a co-occurrence of pain and opioid administration exists as is the common clinical case of a patient with acute pain and taking opioid analgesics. A patient population for whom the combined effects of pain and opioids on immune function are particularly complex are the estimated 5.2 million Americans aged 12 or older who abuse prescription opioids. Not only are these individuals at risk for poor pain management due to their status as an "addict", but there is good preclinical evidence to suggest that their chronic opioid use brings with it a general state of systemic inflammation, and thus setting the patient up for a unique or enhanced inflammatory response to the combination of acute opioids and pain. To better understand the health implications of treating acute pain with opioids in patients and in particular, those who abuse prescription opioids, inflammatory responses to the main and interaction effects of acute pain and opioid administration will be examined in well-characterized samples of each. Specifically, we will evaluate the inflammatory and cytokine responses to: (1) experimental pain; (2) an acute opioid challenge; and (3) the combination of opioid administration followed by cold-pressor pain, in healthy control subjects and age- and gender-matched prescription opioid abusers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* male and non-pregnant female, non-smoking adults in good general health\n* between the ages of 21-40 years old\n* fluent in English with willingness to participate in the research study\n\nSupplementary Inclusion Criteria: Prescription Opioid Abusers\n\n* DSM-IVR diagnosis of prescription opioid abuse or dependence disorder\n* compliance in treatment and on a stable dose of buprenorphine (6-24mg/day) x at least 10 days prior to screening\n* Participation in an ISAP treatment program or a qualified community-based opioid treatment program or private clinic for the entire duration of their study participation\n\nExclusion criteria:\n\n* regular use of any medication that influences immune status or immune system function\n* regular use of a medication that influences pain perception, including opioids (\\* only for healthy subjects population\\*)\n* Regular use of a medication that influences pain perception, except for buprenorphine (\\*\\* only for POA population\\*\\*)\n* known hypersensitivity to opioids or no previous opioid exposure (\\*only healthy controls)\n* presence of acute or chronic pain syndrome\n* neuropsychiatric illness (i.e., peripheral neuropathy, schizophrenia) known to affect pain perception\n* presence of chronic immune compromise (hepatitis C, HIV) or acute infection within the last four weeks\n* current or past history of high blood pressure, heart disease, or stroke, or currently have a pacemaker.\n* current DSM-IV diagnosis\n* BMI less than 18.5 or greater than 29.9\n* History of sleep apnea'}, 'identificationModule': {'nctId': 'NCT01210066', 'briefTitle': 'Pain, Opioids and Pro-Inflammatory Immune Responses', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Pain, Opioids and Pro-Inflammatory Immune Responses', 'orgStudyIdInfo': {'id': '5R21DA027558', 'link': 'https://reporter.nih.gov/quickSearch/5R21DA027558', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pain Challenge', 'description': 'Cold pressor test', 'interventionNames': ['Other: Cold pressor test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pain + Opioid Challenge', 'description': 'IV fentanyl 1mcg/kg followed by cold pressor test', 'interventionNames': ['Other: Fentanyl plus cold pressor test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Opioid Challenge', 'description': 'Administration of fentanyl 1mcg/kg of subject weight', 'interventionNames': ['Drug: Fentanyl']}], 'interventions': [{'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['opioid'], 'description': 'IV fentanyl 1mcg/kg', 'armGroupLabels': ['Opioid Challenge']}, {'name': 'Cold pressor test', 'type': 'OTHER', 'otherNames': ['cold pressor task'], 'description': 'Non-dominant arm submerged in ice water (0 degrees Celsius) until it is no longer tolerable but less than 5 minutes', 'armGroupLabels': ['Pain Challenge']}, {'name': 'Fentanyl plus cold pressor test', 'type': 'OTHER', 'otherNames': ['opioid and cold pressor'], 'description': 'fentanyl IV 1mcg/kg fifteen minutes prior to cold pressor test (arm submerged in ice water until no longer tolerable but no longer than 5 minutes)', 'armGroupLabels': ['Pain + Opioid Challenge']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA School of Nursing', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Peggy A Compton, RN PhD FAAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}