Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2026-01-03 @ 7:53 PM
Study NCT ID:
NCT03980561
Status:
COMPLETED
Last Update Posted:
2024-01-18
First Post:
2019-06-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
UH3 Varenicline for Cannabis Use Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002189', 'term': 'Marijuana Abuse'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068580', 'term': 'Varenicline'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011810', 'term': 'Quinoxalines'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wagne@musc.edu', 'phone': '8437920484', 'title': 'Amanda Wagner', 'organization': 'MUSC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "Varenicline's efficacy for cannabis use disorder may vary by sex; however, this study was not powered to fully explore potential sex differences."}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).', 'eventGroups': [{'id': 'EG000', 'title': 'Varenicline', 'description': '2 mg daily\n\nVarenicline: Active medication', 'otherNumAtRisk': 90, 'deathsNumAtRisk': 90, 'otherNumAffected': 81, 'seriousNumAtRisk': 90, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': '2 mg daily\n\nPlacebo: Inactive medication', 'otherNumAtRisk': 84, 'deathsNumAtRisk': 84, 'otherNumAffected': 70, 'seriousNumAtRisk': 84, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'anxiety/depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'dream disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 54, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 32, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 28, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 22, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 21, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 64, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 24, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'other GI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 45, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 29, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'URI/cold symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 27, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Varenicline', 'description': '2 mg daily\n\nVarenicline: Active medication'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 mg daily\n\nPlacebo: Inactive medication'}], 'classes': [{'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.3', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '11.6', 'spread': '11.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.4', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '11.7', 'spread': '11.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.4', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '10.5', 'spread': '11.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.5', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '9.7', 'spread': '10.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.2', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '10.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.4', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '12.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.4', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '11.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Treatment phase Weeks 6-12', 'description': 'Cannabis use reduction was measured by daily substance use logs/self-report and examined as the total number of use sessions reported at each weekly visit.', 'unitOfMeasure': 'number of weekly use sessions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Week 6 participants'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of Varenicline vs. Placebo When Used for Cannabis Use Disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Varenicline', 'description': '2 mg daily\n\nVarenicline: Active medication'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 mg daily\n\nPlacebo: Inactive medication'}], 'classes': [{'title': 'All reported adverse events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '406', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}]}, {'title': 'Medication-related adverse events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '238', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}]}, {'title': 'Serious adverse events related to treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adverse events resulting in temporary or permanent medication discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks (across the active treatment period)', 'description': 'Comparing the frequency of participant-reported treatment-emergent AEs between treatment groups. Of particular interest will be AEs leading to medication discontinuation and the occurrence of treatment-related serious AEs.', 'unitOfMeasure': 'number of adverse events', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants reporting an adverse event during 12 week active treatment period'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Varenicline', 'description': '2 mg daily\n\nVarenicline: Active medication'}, {'id': 'FG001', 'title': 'Placebo', 'description': '2 mg daily\n\nPlacebo: Inactive medication'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '84'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '25'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Varenicline', 'description': '2 mg daily\n\nVarenicline: Active medication'}, {'id': 'BG001', 'title': 'Placebo', 'description': '2 mg daily\n\nPlacebo: Inactive medication'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-05', 'size': 378864, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-12-19T12:11', 'hasProtocol': True}, {'date': '2022-02-15', 'size': 2113891, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-07-25T09:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-21', 'studyFirstSubmitDate': '2019-06-06', 'resultsFirstSubmitDate': '2023-12-21', 'studyFirstSubmitQcDate': '2019-06-07', 'lastUpdatePostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-21', 'studyFirstPostDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions', 'timeFrame': 'Treatment phase Weeks 6-12', 'description': 'Cannabis use reduction was measured by daily substance use logs/self-report and examined as the total number of use sessions reported at each weekly visit.'}], 'secondaryOutcomes': [{'measure': 'Safety and Tolerability of Varenicline vs. Placebo When Used for Cannabis Use Disorder', 'timeFrame': '12 weeks (across the active treatment period)', 'description': 'Comparing the frequency of participant-reported treatment-emergent AEs between treatment groups. Of particular interest will be AEs leading to medication discontinuation and the occurrence of treatment-related serious AEs.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['marijuana', 'substance use'], 'conditions': ['Cannabis Use Disorder']}, 'descriptionModule': {'briefSummary': 'Marijuana is the most commonly used illicit drug. There is high demand for effective interventions for cannabis use disorder, yet few specific treatments for have been developed. This study will evaluate the efficacy of varenicline for reducing marijuana use in people who use marijuana frequently.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must meet DSM-5 criteria for cannabis use disorder and use cannabis at least 3 days per week in the last 30 days.\n* Express interest in receiving treatment for cannabis use disorder and reducing use.\n* Must be at least 18 years of age.\n* If female and of childbearing potential, must agree to use acceptable methods of birth control for the duration of the trial.\n* Must consent to random assignment, and be willing to commit to medication ingestion.\n* Must be able to read and provide informed consent.\n* Must have body weight \\>110lbs (50kg) and have BMI between 18 and 35kg/m2\n* Must function at an intellectual level and have knowledge of the English language to sufficiently allow for accurate completion of assessments.\n\nExclusion Criteria:\n\n* Women who are pregnant, nursing, or plan to become pregnant during the course of the study.\n* Individuals with severe renal impairment (creatinine clearance less than 30 mL per minute).\n* Lifetime history of DSM-5 Bipolar I or II Disorder, Schizophrenia or other psychotic disorder. Stably treated MDD, Dysthymia, GAD, Social Phobia, and Specific Phobia diagnoses are acceptable (i.e. same dose of medication has been prescribed for at least 2 months prior to screening and no changes in current medication expected during course of the trial).\n* Past year or current posttraumatic stress disorder.\n* Subjects who are actively suicidal, or who report suicidal ideation (SI) with intent or plan in the past year.\n* Subjects who have a SBQ R total score ≥8, or for whom the investigator judges that a risk assessment by a qualified medical professional is required. Subjects answering 'yes' on questions 4 or 5 of C-SSRS will be referred to assessment by a qualified mental health professional.\n* Suicidal behavior within the past 10 years or a lifetime history of serious or recurrent suicidal behavior.\n* Concomitant use of psychotropic medications, with the exception of stable doses (defined as no dosing adjustments in the past two months) of non-MAO-I antidepressants, non-benzodiazepine anxiolytics, and ADHD medications.\n* Current use of medications prescribed for mania or psychosis.\n* Current use of buproprion or nortryptiline.\n* Moderate or severe non-cannabis substance use disorders within the past 60 days with the exception of tobacco use disorder.\n* Past year or current moderate or severe alcohol use disorder.\n* Individuals taking an investigational agent within the last 30 days before baseline visit.\n* Individuals with clinically significant medical disorders or lab abnormalities.\n* Any individual at screening with SGOT (AST) or SGPT (ALT) greater than 3 times the upper limit of normal and/or total bilirubin greater than two times the upper limit of normal.\n* Individuals with clinically significant cardiovascular disease in the past 6 months (e.g., myocardial infarction, CABG, PTCA, severe or unstable angina, serious arrhythmia, or any clinically significant ECG conduction abnormality.\n* Individuals with clinically significant cerebrovascular disease in the past 6 months such as TIA, CVA, or stroke.\n* Hypersensitivity to varenicline.\n* Individuals who have participated in the clinical trial of any investigative compound within the last 60 days\n* Individuals who are on probation or under a mandate to obtain treatment.\n* Individuals with plans to initiate or change frequency of attendance at self-help meetings (e.g. AA, NA)."}, 'identificationModule': {'nctId': 'NCT03980561', 'briefTitle': 'UH3 Varenicline for Cannabis Use Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Varenicline for the Treatment of DSM 5 Cannabis Use Disorder in Adults', 'orgStudyIdInfo': {'id': 'PRO00089933'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Varenicline', 'description': '2 mg daily', 'interventionNames': ['Drug: Varenicline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '2 mg daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Varenicline', 'type': 'DRUG', 'otherNames': ['Chantix, Apo-Varenicline'], 'description': 'Active medication', 'armGroupLabels': ['Varenicline']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sugar pill'], 'description': 'Inactive medication', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29671', 'city': 'Pickens', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Behavioral Health Services of Pickens County', 'geoPoint': {'lat': 34.88345, 'lon': -82.70736}}], 'overallOfficials': [{'name': 'Aimee McRae-Clark, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}