Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT05729932
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2023-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cannabis and Opioid Use Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2023-01-13', 'studyFirstSubmitQcDate': '2023-02-06', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline - Opioid Withdrawal Severity - Visual Analog Scale (VAS)', 'timeFrame': 'Change from baseline', 'description': 'Subjective ratings of opioid withdrawal severity on visual analog scale (scale 0-100; 0 = not at all, 100 = extremely)'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline - Opioid Drug Liking - Visual Analog Scale (VAS)', 'timeFrame': 'Change from baseline', 'description': 'Subjective ratings of drug liking on visual analog scale (scale 0-100, 0 = not at all, 100 = extremely)'}, {'measure': 'Change from Baseline - Respiration', 'timeFrame': 'Change from baseline', 'description': 'Physiological monitoring of respiration rate (breaths per minute)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Use Disorder']}, 'descriptionModule': {'briefSummary': 'This study plans to enroll participants with opioid use disorder who are not currently seeking treatment to assess the effects of cannabis on opioid withdrawal and other related outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current opioid use disorder\n\nExclusion Criteria:\n\n* Current medical conditions that require medical management'}, 'identificationModule': {'nctId': 'NCT05729932', 'briefTitle': 'Cannabis and Opioid Use Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Cannabis Modulation of Outcomes Related to Opioid Use Disorder: Opioid Withdrawal, Abuse Potential and Safety', 'orgStudyIdInfo': {'id': '75562-20242'}, 'secondaryIdInfos': [{'id': '1R01DA054347', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA054347', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intranasal Opioid Agonist', 'description': 'Participants will receive non-therapeutic, experimental doses of an opioid agonist or placebo. Active opioid agonist/placebo will be administered once per session and will be administered intransally (snorting).', 'interventionNames': ['Drug: Inhaled vaporized cannabis', 'Drug: Intransal opioid']}, {'type': 'EXPERIMENTAL', 'label': 'Vaporized cannabis', 'description': 'Participants will receive non-therapeutic, experimental doses of active or placebo vaporized cannabis. Active cannabis/placebo will be administered once per session and will be administered via a vaporizer.', 'interventionNames': ['Drug: Inhaled vaporized cannabis', 'Drug: Intransal opioid']}], 'interventions': [{'name': 'Inhaled vaporized cannabis', 'type': 'DRUG', 'description': 'Double-blind cannabis and placebo doses, administered through vaporizer', 'armGroupLabels': ['Intranasal Opioid Agonist', 'Vaporized cannabis']}, {'name': 'Intransal opioid', 'type': 'DRUG', 'description': 'Double-blind opioid and placebo doses, administered intranasal route', 'armGroupLabels': ['Intranasal Opioid Agonist', 'Vaporized cannabis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40508', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Paul Nuzzo, MA', 'role': 'CONTACT', 'email': 'pnuzz2@email.uky.edu', 'phone': '859-323-0002'}], 'facility': 'Center on Drug and Alcohol Research', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'centralContacts': [{'name': 'Paul Nuzzo, MA', 'role': 'CONTACT', 'email': 'pnuzz2@email.uky.edu', 'phone': '859-323-0002'}], 'overallOfficials': [{'name': 'Shanna Babalonis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kentucky', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Shanna Babalonis, PhD', 'investigatorAffiliation': 'University of Kentucky'}}}}