Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002189', 'term': 'Marijuana Abuse'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077236', 'term': 'Topiramate'}], 'ancestors': [{'id': 'D005632', 'term': 'Fructose'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007661', 'term': 'Ketoses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Robert_Miranda_Jr@brown.edu', 'phone': '401.863.6658', 'title': 'Dr. Robert Miranda', 'organization': 'Brown University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Data were collected during the 6-week medication (or placebo pill) period.', 'description': 'We followed the same definition as clinicaltrials.gov.', 'eventGroups': [{'id': 'EG000', 'title': 'Topiramate', 'description': 'Topiramate (200 mg daily)\n\nTopiramate: Topiramate (200 mg daily)', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 35, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sugar Pill', 'description': 'Placebo: Placebo (daily)', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 24, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough, Cold Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Parasthesias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sore Throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Runny Nose, Sinus Problems, Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach Pain, Cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Changes in Vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decrease in Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Difficulty with Coordination or Balance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Difficulty with Memory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Difficulty with Concentration or Attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Word Finding Difficulties', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Slow Thinking or Reactions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drowsiness or Sleepiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cannabis Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topiramate', 'description': 'Topiramate (200 mg daily)\n\nTopiramate: Topiramate (200 mg daily)'}, {'id': 'OG001', 'title': 'Sugar Pill', 'description': 'Placebo: Placebo (daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '55.89', 'spread': '32.35', 'groupId': 'OG000'}, {'value': '63.10', 'spread': '34.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1-6', 'description': 'Frequency of Cannabis Use (Percent Use Days Per Week)', 'unitOfMeasure': 'Percentage of use days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quantity of Cannabis Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topiramate', 'description': 'Topiramate (200 mg daily)\n\nTopiramate: Topiramate (200 mg daily)'}, {'id': 'OG001', 'title': 'Sugar Pill', 'description': 'Placebo: Placebo (daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.87', 'spread': '2.11', 'groupId': 'OG000'}, {'value': '2.85', 'spread': '3.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1-6', 'description': 'Total Grams of Cannabis Use Per week', 'unitOfMeasure': 'Grams Per Week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Amount of Cannabis Use Per Use Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topiramate', 'description': 'Topiramate (200 mg daily)\n\nTopiramate: Topiramate (200 mg daily)'}, {'id': 'OG001', 'title': 'Sugar Pill', 'description': 'Placebo: Placebo (daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.46', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.60', 'spread': '0.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1-6', 'description': 'Average Grams of Cannabis Used Per Use Day', 'unitOfMeasure': 'Average Grams Per Use Day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Topiramate', 'description': 'Topiramate (200 mg daily)\n\nTopiramate: Topiramate (200 mg daily)'}, {'id': 'FG001', 'title': 'Sugar Pill', 'description': 'Placebo: Placebo (daily)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Topiramate', 'description': 'Topiramate (200 mg daily)\n\nTopiramate: Topiramate (200 mg daily)'}, {'id': 'BG001', 'title': 'Sugar Pill', 'description': 'Placebo: Placebo (daily)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.30', 'spread': '2.03', 'groupId': 'BG000'}, {'value': '18.81', 'spread': '2.08', 'groupId': 'BG001'}, {'value': '19.71', 'spread': '2.16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-27', 'studyFirstSubmitDate': '2010-04-20', 'resultsFirstSubmitDate': '2020-08-27', 'studyFirstSubmitQcDate': '2010-04-23', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-27', 'studyFirstPostDateStruct': {'date': '2010-04-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cannabis Use', 'timeFrame': 'Weeks 1-6', 'description': 'Frequency of Cannabis Use (Percent Use Days Per Week)'}], 'secondaryOutcomes': [{'measure': 'Quantity of Cannabis Use', 'timeFrame': 'Weeks 1-6', 'description': 'Total Grams of Cannabis Use Per week'}, {'measure': 'Amount of Cannabis Use Per Use Day', 'timeFrame': 'Weeks 1-6', 'description': 'Average Grams of Cannabis Used Per Use Day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cannabis Abuse', 'Cannabis Dependence']}, 'referencesModule': {'references': [{'pmid': '34014688', 'type': 'DERIVED', 'citation': 'Meisel SN, Carpenter RW, Treloar Padovano H, Miranda R. Day-level shifts in social contexts during youth cannabis use treatment. J Consult Clin Psychol. 2021 Apr;89(4):251-263. doi: 10.1037/ccp0000647.'}, {'pmid': '29672090', 'type': 'DERIVED', 'citation': 'Treloar Padovano H, Miranda R. Subjective cannabis effects as part of a developing disorder in adolescents and emerging adults. J Abnorm Psychol. 2018 Apr;127(3):282-293. doi: 10.1037/abn0000342.'}]}, 'descriptionModule': {'briefSummary': 'Cannabis use is a significant public health concern that disproportionately affect youth. Although promising psychosocial interventions are being developed, most youth do not benefit from these interventions alone. Given the clinical demand for effective treatments, the National Institute on Drug Abuse (NIDA) identified the critical need for data on the tolerability and potential efficacy of medications in adolescents. The purpose of this two-year study is to test if and how topiramate, a medication under intense study for treating several drugs of abuse, reduces cannabis use among teenagers. To this end, the investigators will randomize 56 nontreatment-seeking regular cannabis users (15 or 20 years old) to receive topiramate or placebo for 6 weeks. Youth will monitor their cannabis use for the 6-week period using handheld electronic diaries and complete assessments of reactivity to cannabis-related cues.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 15 to 20 years old (inclusive)\n* Non-treatment seeking for cannabis abuse or dependence\n* Able to read English, understand their rights as provided by the informed consent process, and be willing to sign an informed consent form to participant in the study\n* If younger than 18 years old, informed consent from a parent or legal guardian is required\n* Used cannabis at least 2 days per week during the past 30 days\n\nExclusion Criteria:\n\n* Treatment seeking or a recent history of treatment for cannabis abuse or dependence\n* Endorses a current commitment to stop using cannabis\n* Clinically significant physical abnormalities as indicated by physical exam, hematological assessment, bilirubin concentration or urinalysis\n* History of renal impairment, renal stones, seizures, or unstable hypertension\n* Underweight (i.e., less than the 5th percentile) or overweight (equal to or greater than the 95th percentile), as determined by the Body Mass Index\n* Positive urine toxicology screen for narcotics, amphetamines, or sedative hypnotics or self-reported drug use, other than cannabis, alcohol or nicotine, in the past 30 days\n* Pregnant, nursing, or refusal to use reliable barrier method of birth control (e.g., condom), if female\n* Took a psychotropic medication in the past 30 days\n* Taking medications with a potential effect on cannabis use or a carbonic anhydrase inhibitor\n* Suicidal\n* A current DSM-IV-TR Axis I diagnosis other than attention- deficit/hyperactivity disorder or a disruptive behavior disorder\n* A current substance use disorder other than a cannabis, alcohol, and nicotine use disorders\n* Significant alcohol withdrawal symptoms\n* Known sensitivity to topiramate'}, 'identificationModule': {'nctId': 'NCT01110434', 'briefTitle': 'Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Brown University'}, 'officialTitle': 'Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents', 'orgStudyIdInfo': {'id': 'R01DA026778', 'link': 'https://reporter.nih.gov/quickSearch/R01DA026778', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01DA026778', 'link': 'https://reporter.nih.gov/quickSearch/R01DA026778', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topiramate', 'description': 'Topiramate (200 mg daily)', 'interventionNames': ['Drug: Topiramate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar pill', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Topiramate', 'type': 'DRUG', 'otherNames': ['Topamax'], 'description': 'Topiramate (200 mg daily)', 'armGroupLabels': ['Topiramate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo (daily)', 'armGroupLabels': ['Sugar pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02912', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Brown University, Center for Alcohol and Addiction Studies', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Robert Miranda, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor (Research)', 'investigatorFullName': 'Robert Miranda', 'investigatorAffiliation': 'Brown University'}}}}