Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-02 @ 4:24 PM
Study NCT ID:
NCT02028533
Status:
COMPLETED
Last Update Posted:
2019-05-21
First Post:
2014-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cocaine Opioid Oxytocin Option - Limited
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-17', 'studyFirstSubmitDate': '2014-01-03', 'studyFirstSubmitQcDate': '2014-01-03', 'lastUpdatePostDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with non-serious and serious adverse events', 'timeFrame': '3 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['addiction', 'oxytocin', 'tolerability'], 'conditions': ['Opioid Use Disorder', 'Cocaine Use Disorder']}, 'descriptionModule': {'briefSummary': 'This is a pilot feasibility study assessing the tolerability of chronic administration of intranasal oxytocin to patients receiving methadone at an opioid replacement clinic who are actively using cocaine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled as a patient in the San Francisco General Hospital Opioid Treatment Outpatient Program\n* Stable dose of methadone for at least the past two weeks\n* At least one routine urine toxicology screen positive for cocaine in the past month\n\nExclusion Criteria:\n\n* Positive urine pregnancy test\n* Use of illicit drugs in the past month (with the exception of cocaine or cannabis)\n* Currently meets Diagnostic and Statistical Manual-5 (DSM-V) criteria for severe major depressive disorder with suicidal thoughts or actions\n* History of psychotic or moderate-severe alcohol use disorder as defined by DSM-V criteria\n* Severe neuropsychological disorder, brain trauma, epilepsy\n* Sensitivity to preservatives (in particular E 216, E 218 and chlorobutanol hemihydrate)\n* Nasal obstruction, discharge, or bleeding\n* Habitually drinks large volumes of water\n* Taking testosterone, estrogen/progesterone supplement, or serotonin-1a receptor agonists/antagonists'}, 'identificationModule': {'nctId': 'NCT02028533', 'acronym': 'COOOL', 'briefTitle': 'Cocaine Opioid Oxytocin Option - Limited', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Chronic Intranasal Oxytocin as an Adjunct to Methadone Maintenance Treatment in Patients With Co-occuring Opioid Use Disorder and Cocaine Use: A 2-week Pilot Study', 'orgStudyIdInfo': {'id': '13-12534'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patients 1', 'description': 'Participants will receive intranasal oxytocin 40 International Units (IU).', 'interventionNames': ['Drug: Oxytocin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Patients 2', 'description': 'Participants will receive 40 International Units of intranasal placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Oxytocin', 'type': 'DRUG', 'otherNames': ['oxytocin nasal spray, Syntocinon'], 'armGroupLabels': ['Patients 1']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['placebo nasal spray'], 'armGroupLabels': ['Patients 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco General Hospital Opiate Treatment Outpatient Program', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Christopher S Stauffer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Joshua Woolley, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Joshua Woolley', 'investigatorAffiliation': 'University of California, San Francisco'}}}}