Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-27 @ 2:49 PM
Study NCT ID:
NCT05114460
Status:
TERMINATED
Last Update Posted:
2025-03-18
First Post:
2021-10-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vaped Marijuana to Attenuate Naloxone-Precipitated Withdrawal
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083682', 'term': 'Opiate Overdose'}], 'ancestors': [{'id': 'D062787', 'term': 'Drug Overdose'}, {'id': 'D063487', 'term': 'Prescription Drug Misuse'}, {'id': 'D000076064', 'term': 'Drug Misuse'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009270', 'term': 'Naloxone'}, {'id': 'C587251', 'term': 'nabiximols'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jermaine.jones@nyspi.columbia.edu', 'phone': '646 774-6113', 'title': 'Jermaine Jones PhD: Research Scientist/Associate Professor', 'organization': 'New York State Psychiatric Institute'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'All Study Participants, the 4-week Inpatient testing period.', 'description': 'An adverse event is any unwanted experience or event occurring during the trial. An adverse event will be defined as serious whenever the outcome is fatal or life-threatening, is significantly or permanently disabling or incapacitating, requires or prolongs inpatient hospitalization, results in permanent disability, results in a congenital anomaly, or is unusual and potentially serious.', 'eventGroups': [{'id': 'EG000', 'title': 'All Study Participants', 'description': 'Adverse events were assessed were collected throughout the 4-week inpatient period.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Opiate Withdrawal Scale (COWS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Naloxone 0 mg + MJ 0.0 mg', 'description': 'Intranasal naloxone in combination with vaped marijuana\n\nNaloxone: Intranasal Naloxone\n\nMarijuana: Vaped Marijuana'}, {'id': 'OG001', 'title': 'Naloxone 0 mg + MJ 12.5 mg', 'description': 'Intranasal naloxone in combination with vaped marijuana\n\nMarijuana: Vaped Marijuana'}, {'id': 'OG002', 'title': 'Naloxone 0 mg + MJ 25 mg', 'description': 'Intranasal naloxone in combination with vaped marijuana (MJ)\n\nMarijuana: Vaped Marijuana'}, {'id': 'OG003', 'title': 'Naloxone 4 mg + MJ 0.0 mg', 'description': 'Intranasal naloxone in combination with vaped marijuana (MJ)\n\nNaloxone: Intranasal Naloxone'}, {'id': 'OG004', 'title': 'Naloxone 4 mg + MJ 12.5 mg', 'description': 'Intranasal naloxone in combination with vaped marijuana (MJ)\n\nNaloxone: Intranasal Naloxone\n\nMarijuana: Vaped Marijuana'}, {'id': 'OG005', 'title': 'Naloxone 4 mg + MJ 25 mg', 'description': 'Intranasal naloxone in combination with vaped marijuana (MJ)\n\nNaloxone: Intranasal Naloxone\n\nMarijuana: Vaped Marijuana'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4-week trial: Peak COWS score throughout the testing session for each dose combination.', 'description': 'Clinical Opiate Withdrawal Scale is an 11-item, clinician-administered measure designed to quantify the severity of opioid withdrawal. The COWS evaluates the severity of the following symptoms on a scale of 0-4 or 5: resting pulse rate, sweating, restlessness, pupil size, bone or joint aches, runny nose or tearing, gastrointestinal upset, tremor, yawning, anxiety, or irritability, and gooseflesh. The score on the COWS ranges from 0 to 48 points with withdrawal ratings between 5-12 considered mild, 13-24 as moderate, 25-36 as moderately severe, and \\>36 considered severe.', 'unitOfMeasure': 'units on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are only available from 1 participant and the other participant enrolled did not complete any testing sessions.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'Randomized, Within-Subjects Design'}], 'periods': [{'title': 'Naloxone 0 mg + Marijuana 0.0 mg', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Naloxone 0 mg + Marijuana 12.5 mg', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Naloxone 0 mg + Marijuana 25 mg', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Naloxone 4 mg + Marijuana 0.0 mg', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Naloxone 4 mg + Marijuana 12.5 mg', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Naloxone 4 mg + Marijuana 25 mg', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '2 participants were enrolled however, 1 participant withdrew from the study prior to completing any of the testing sessions (i.e., periods).', 'preAssignmentDetails': 'After enrollment/admission and prior to testing participants were transition from illicit opioids onto a stable daily dose of a prescription opioid.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Two participants were enrolled in the within-subjects trial.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '50'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Two participants were enrolled, however, one participant withdrew themselves from the study, prior to testing to accept a work assignment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-15', 'size': 558927, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-26T12:35', 'hasProtocol': True}, {'date': '2020-03-26', 'size': 140658, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-03T15:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'The U.S. Department of Health and Human Services Office of Human Research Protections issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023. Recruitment for this trial will not reopen.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2021-10-05', 'resultsFirstSubmitDate': '2024-12-26', 'studyFirstSubmitQcDate': '2021-11-09', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-03', 'studyFirstPostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Opiate Withdrawal Scale (COWS)', 'timeFrame': '4-week trial: Peak COWS score throughout the testing session for each dose combination.', 'description': 'Clinical Opiate Withdrawal Scale is an 11-item, clinician-administered measure designed to quantify the severity of opioid withdrawal. The COWS evaluates the severity of the following symptoms on a scale of 0-4 or 5: resting pulse rate, sweating, restlessness, pupil size, bone or joint aches, runny nose or tearing, gastrointestinal upset, tremor, yawning, anxiety, or irritability, and gooseflesh. The score on the COWS ranges from 0 to 48 points with withdrawal ratings between 5-12 considered mild, 13-24 as moderate, 25-36 as moderately severe, and \\>36 considered severe.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Overdose']}, 'referencesModule': {'references': [{'pmid': '40839512', 'type': 'DERIVED', 'citation': 'Jones JD, Martinez S, Arout C, Haney M, Castillo F, Manubay J, Perez F, Luba RR, Comer SD. The effects of vaped cannabis on the severity of naloxone-precipitated opioid withdrawal. Exp Clin Psychopharmacol. 2025 Aug 21:10.1037/pha0000796. doi: 10.1037/pha0000796. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The goal of the proposed, proof-of-concept study is to test the combined effects of vaporized marijuana \\[Delta-9-tetrahydracannabinol (THC)\\] with NLX as a proof of concept towards the possible development of a combined overdose reversal agent with improved tolerability.', 'detailedDescription': 'The goal of the proposed, proof-of-concept study is to test the combined effects of vaporized marijuana \\[Delta-9-tetrahydracannabinol (THC)\\] with NLX as a proof of concept towards the possible development of a combined overdose reversal agent with improved tolerability. Marijuana plant material will be obtained from the National Institutes on Drug Abuse (NIDA). In clinical studies, oral synthetic THC reduced the severity of opioid withdrawal during opioid detoxification. Clinically, cannabinoid drugs like Marinol® (oral synthetic THC), Sativex ® (nabixomols), and Cesamet® (nabilone) are used to treat nausea and vomiting, common symptoms of opioid withdrawal. This study will investigate the ability of vaporized marijuana (V-MJ) (0.00, 12.5, and 25 mg: concentration= 11.7% THC + 0.04% CBD) to reduce the severity of opioid withdrawal precipitated by intranasal (IN) NLX (0.0 and 4.0 mg). This trial will recruit healthy participants with opioid use disorder (N=16, completers). Testing will begin following stabilization on oral morphine (120 mg/day), which will continue throughout the trial. During each testing session, a single V-MJ + naloxone dose combination will be assessed (in randomized order), with 48 hours between testing sessions. Laboratory testing sessions will consist of a modified naloxone challenge procedure, which quantifies the severity of naloxone-precipitated opioid withdrawal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 18-55 years of age.\n2. Diagnostic criteria for Opioid Use Disorder (OUD) moderate-severe (304.00) as per DSM-V, including physiological dependence and not currently seeking treatment for OUD.\n3. Self-reported opioid use for nontherapeutic purposes; and positive urine drug screen for opioids.\n4. Physically healthy.\n5. Normal body weight/Within 20% of body weight (for appropriate frame) according to 1983 Metropolitan Weight tables.\n6. Able to perform study procedures.\n7. Females must be either:\n\n 1. Post-menopausal (amenorrhea for at least 12 consecutive months), surgically sterile -or\n 2. Women of childbearing potential must agree to use an acceptable double-barrier method of contraception during screening and study participation.\n8. Must smoke \\< three cannabis cigarettes three times a week (or the vaping equivalent) for the four weeks before screening.\n\nExclusion Criteria:\n\n1. Seeking treatment for Opioid Use Disorder.\n2. Current or history of a psychiatric condition that would affect participants' ability to provide informed consent (e.g., mood disorder with functional impairment or schizophrenia) or make participant hazardous for the participant (e.g., recent suicidal ideation) or staff (e.g., significant history of violence).\n3. Current DSM-V diagnosis of substance use disorders requiring medically managed detoxification, other than OUD (e.g., alcohol or benzodiazepine dependence).\n4. Medical condition resulting in chronic pain (\\>3 months).\n5. Clinically significant abnormality on physical examination, vital signs, screening laboratory tests, or 12- lead ECG.\n6. Significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, or neurologic disorder.\n7. Any surgical, or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the study drugs.\n8. Baseline hypotension, orthostatic hypotension or syncope, hypertension (blood pressure \\> 140/90), pulmonary hypertension or heart disease.\n9. Any of the following values for laboratory tests:\n\n 1. positive pregnancy test,\n 2. hemoglobin \\< 12 g/dL in males and \\< 11 g/dL in females,\n 3. neutrophil count \\< 1.0 × 109/L,\n 4. platelet count \\< 75 × 109/L,\n 5. creatinine clearance \\< 50 ml/min per modified Cockcroft-Gault equation,\n 6. aspartate aminotransferase or alanine aminotransferase \\> 3.0 × upper limit of normal.\n10. Hypersensitivity to opioids, history of significant adverse reactions to cannabinoids, and allergy or contraindication to any other drugs administered as a part of this investigation.\n11. Use of an investigational agent within 30 days."}, 'identificationModule': {'nctId': 'NCT05114460', 'briefTitle': 'Vaped Marijuana to Attenuate Naloxone-Precipitated Withdrawal', 'organization': {'class': 'OTHER', 'fullName': 'New York State Psychiatric Institute'}, 'officialTitle': 'The Ability of Vaped Marijuana to Reduce the Severity of Naloxone-Precipitated Withdrawal', 'orgStudyIdInfo': {'id': '8061'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Naloxone 0 mg + MJ 0.0 mg', 'description': 'Intranasal naloxone in combination with vaped marijuana', 'interventionNames': ['Drug: Naloxone', 'Drug: Marijuana']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Naloxone 0 mg + MJ 12.5 mg', 'description': 'Intranasal naloxone in combination with vaped marijuana', 'interventionNames': ['Drug: Marijuana']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Naloxone 0 mg + MJ 25 mg', 'description': 'Intranasal naloxone in combination with vaped marijuana (MJ)', 'interventionNames': ['Drug: Marijuana']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Naloxone 4 mg + MJ 0.0 mg', 'description': 'Intranasal naloxone in combination with vaped marijuana (MJ)', 'interventionNames': ['Drug: Naloxone']}, {'type': 'EXPERIMENTAL', 'label': 'Naloxone 4 mg + MJ 12.5 mg', 'description': 'Intranasal naloxone in combination with vaped marijuana (MJ)', 'interventionNames': ['Drug: Naloxone', 'Drug: Marijuana']}, {'type': 'EXPERIMENTAL', 'label': 'Naloxone 4 mg + MJ 25 mg', 'description': 'Intranasal naloxone in combination with vaped marijuana (MJ)', 'interventionNames': ['Drug: Naloxone', 'Drug: Marijuana']}], 'interventions': [{'name': 'Naloxone', 'type': 'DRUG', 'description': 'Intranasal Naloxone', 'armGroupLabels': ['Naloxone 0 mg + MJ 0.0 mg', 'Naloxone 4 mg + MJ 0.0 mg', 'Naloxone 4 mg + MJ 12.5 mg', 'Naloxone 4 mg + MJ 25 mg']}, {'name': 'Marijuana', 'type': 'DRUG', 'description': 'Vaped Marijuana', 'armGroupLabels': ['Naloxone 0 mg + MJ 0.0 mg', 'Naloxone 0 mg + MJ 12.5 mg', 'Naloxone 0 mg + MJ 25 mg', 'Naloxone 4 mg + MJ 12.5 mg', 'Naloxone 4 mg + MJ 25 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York State Psychiatric Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jermaine Jones, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York State Psychiatric Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York State Psychiatric Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jermaine D. Jones', 'investigatorAffiliation': 'New York State Psychiatric Institute'}}}}