Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 5:32 PM
Study NCT ID:
NCT05761860
Status:
RECRUITING
Last Update Posted:
2025-04-24
First Post:
2023-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Potential of Oxytocin to Reduce Opioid Abuse Liability and Pain Among Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010098', 'term': 'Oxycodone'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D003061', 'term': 'Codeine'}, {'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'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is a within-participant study so that each participant receives all conditions.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-21', 'studyFirstSubmitDate': '2023-02-27', 'studyFirstSubmitQcDate': '2023-02-27', 'lastUpdatePostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subject-rated abuse liability', 'timeFrame': 'Up to 6 weeks', 'description': 'Using a Visual Analog Scale with scoring as 0=not at all, 20=possibly mild, 40=definitely mild, 60=moderately, 80=strongly, and 100=extremely, or any number in between. Testing occurs only in the context of 6 sessions due to a minimum of a one week washout period in between each session.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain', 'Abuse liability'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Some research suggests that administration of oxytocin with oxycodone may reduce its abuse liability and improve its ability to reduce pain. In a 6-session laboratory study, we will be evaluating the effects of oxycodone and oxytocin (combined and separately, across sessions) on experimentally-induced pain, subjective effects, and decision-making.', 'detailedDescription': "The overall project goals are to determine oxytocin effects on oxycodone's subject-rated abuse liability, and experimental pain. Generally healthy individuals (determined via medical history review and a screening session) will, after informed consent, self-administer intranasal oxytocin (or placebo, containing the same ingredients but no oxytocin) shortly after oral oxycodone or placebo in a non-residential, double-blind, randomized, placebo-controlled, within-subjects laboratory study. Prescreening will assure drug application safety and, using a validated, comprehensive pain history interview, determine previous or existing chronic pain conditions, including current pain medication use."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Individuals fluent in English will participate.\n* Must report some experience with opioids (e.g., oxycodone, defined as use at least once in the subject's lifetime).\n* Be within 20% of their ideal body weight.\n* Are not currently experiencing chronic pain (pain on most days during the past 3 months)\n* Have a systolic blood pressure of \\<=140 and diastolic blood pressure of \\<= 90, and a heart rate \\<= 90 beats per minute.\n* Participants must also have a normal electrocardiogram (EKG) reading and bloodwork indicating no major health contraindications.\n\nExclusion Criteria:\n\n* Significant current physical disease or major (uncontrolled) psychiatric disorder.\n* No self-reported current interest in drug abuse treatment.\n* Women who are pregnant or nursing.\n* Any severe comorbid illicit substance use disorders or current clinically significant withdrawal for any abused drug excluding nicotine and caffeine."}, 'identificationModule': {'nctId': 'NCT05761860', 'briefTitle': 'The Potential of Oxytocin to Reduce Opioid Abuse Liability and Pain Among Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'The Potential of Oxytocin to Reduce Opioid Abuse Liability and Pain Among Older Adults', 'orgStudyIdInfo': {'id': 'IRB202300435'}, 'secondaryIdInfos': [{'id': '5R21DA056813-02', 'link': 'https://reporter.nih.gov/quickSearch/5R21DA056813-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oral oxycodone (5mg) + intranasal oxytocin (48 IU)', 'description': 'Combined effects of oxycodone and oxytocin.', 'interventionNames': ['Drug: OxyCODONE 5 mg Oral Tablet', 'Drug: Oxytocin Nasal Spray (48 IU)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU)', 'description': 'Combined effects of oxycodone and oxytocin.', 'interventionNames': ['Drug: OxyCODONE 2.5 mg Oral Tablet', 'Drug: Oxytocin Nasal Spray (48 IU)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral placebo + intranasal oxytocin (48 IU)', 'description': 'Separate effects of oxytocin. As is standard methodology in abuse liability and pain assessments, a placebo condition will be included for each drug in order to compare the abuse liability and pain assessments change from placebo.', 'interventionNames': ['Other: Placebo oxyCODONE Oral Tablet', 'Drug: Oxytocin Nasal Spray (48 IU)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral oxycodone (5mg) + intranasal placebo', 'description': 'Separate effects of oxycodone. As is standard methodology in abuse liability and pain assessments, a placebo condition will be included for each drug in order to compare the abuse liability and pain assessments change from placebo.', 'interventionNames': ['Drug: OxyCODONE 5 mg Oral Tablet', 'Other: Placebo Oxytocin Nasal Spray']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral oxycodone (2.5mg) + intranasal placebo', 'description': 'Separate effects of oxycodone. As is standard methodology in abuse liability and pain assessments, a placebo condition will be included for each drug in order to compare the abuse liability and pain assessments change from placebo.', 'interventionNames': ['Drug: OxyCODONE 2.5 mg Oral Tablet', 'Other: Placebo Oxytocin Nasal Spray']}, {'type': 'SHAM_COMPARATOR', 'label': 'Oral placebo + intranasal placebo', 'description': 'Serves as the control.', 'interventionNames': ['Other: Placebo oxyCODONE Oral Tablet', 'Other: Placebo Oxytocin Nasal Spray']}], 'interventions': [{'name': 'OxyCODONE 5 mg Oral Tablet', 'type': 'DRUG', 'description': 'Oxycodone 5mg oral administration', 'armGroupLabels': ['Oral oxycodone (5mg) + intranasal oxytocin (48 IU)', 'Oral oxycodone (5mg) + intranasal placebo']}, {'name': 'OxyCODONE 2.5 mg Oral Tablet', 'type': 'DRUG', 'description': 'Oxycodone 2.5mg oral administration', 'armGroupLabels': ['Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU)', 'Oral oxycodone (2.5mg) + intranasal placebo']}, {'name': 'Placebo oxyCODONE Oral Tablet', 'type': 'OTHER', 'description': 'Oxycodone 0mg (placebo) oral administration', 'armGroupLabels': ['Oral placebo + intranasal oxytocin (48 IU)', 'Oral placebo + intranasal placebo']}, {'name': 'Oxytocin Nasal Spray (48 IU)', 'type': 'DRUG', 'description': 'Intranasal oxytocin administration (48 IU)', 'armGroupLabels': ['Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU)', 'Oral oxycodone (5mg) + intranasal oxytocin (48 IU)', 'Oral placebo + intranasal oxytocin (48 IU)']}, {'name': 'Placebo Oxytocin Nasal Spray', 'type': 'OTHER', 'description': 'Intranasal oxytocin placebo administration', 'armGroupLabels': ['Oral oxycodone (2.5mg) + intranasal placebo', 'Oral oxycodone (5mg) + intranasal placebo', 'Oral placebo + intranasal placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lauren E Nieder, MSPH', 'role': 'CONTACT', 'email': 'lauren.nieder@ufl.edu', 'phone': '352-294-1067'}, {'name': 'Meredith S Berry, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'centralContacts': [{'name': 'Lauren E Nieder, MSPH', 'role': 'CONTACT', 'email': 'lauren.nieder@ufl.edu', 'phone': '(352) 294-1067'}], 'overallOfficials': [{'name': 'Meredith S Berry, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}