Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-01-01 @ 9:03 PM
Study NCT ID:
NCT00421603
Status:
COMPLETED
Last Update Posted:
2019-04-24
First Post:
2007-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Placebo-Controlled Study of Mixed Amphetamine Salts and Topiramate for the Treatment of Cocaine Dependence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019970', 'term': 'Cocaine-Related Disorders'}, {'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C449521', 'term': 'SLI381'}, {'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': 'brooksd@nyspi.columbia.edu', 'phone': '212-740-3205', 'title': 'Daniel Brooks', 'organization': 'NYSPI'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The two-arm placebo controlled design does not allow us to address whether both medications are necessary for efficacy. Potential limited treatment masking that occurred when giving two medications with distinctive adverse effect profiles.'}}, 'adverseEventsModule': {'timeFrame': 'during 14 weeks of trial or length of participants participation', 'eventGroups': [{'id': 'EG000', 'title': 'Adderall-XR and Topiramate', 'description': 'Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.', 'otherNumAtRisk': 39, 'otherNumAffected': 33, 'seriousNumAtRisk': 39, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo daily dose', 'otherNumAtRisk': 42, 'otherNumAffected': 21, 'seriousNumAtRisk': 42, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased/decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GI upset', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'substance-induced mood syndrome', 'notes': 'One participant in the MAS-ER and topiramate group developed a substance-induced mood syndrome and required hospitalization.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'residential drug treatment', 'notes': 'The other participant in the placebo group voluntarily discontinued study participation during the final week of the trial and entered a residential substance abuse treatment center.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Three Weeks of Continuous Cocaine Abstinence as Measured by Urine Toxicology and Self Report Based on Time Line Follow Back', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adderall-XR and Topiramate', 'description': 'Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo daily dose'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The dichotomous primary outcome was analyzed using logistic regression with independent predictors: treatment (MAS-ER and topiramate vs. placebo) and adjusted for baseline severity of cocaine use (total number of cocaine use days in the 28 days prior to randomization).', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'All analyses were conducted on the intent-to-treat sample of all randomized patients. All statistical tests were 2-tailed and employed at a significance level of 5%, unless otherwise stated. The original sample size of 120 patients was chosen to ensure sufficient power (at least 80%) of a two-sided test with level of significance α=0.05 for detecting difference between the two experimental treatments with respect to the percentage of subjects who achieve continuous 3-weeks abstinence.'}], 'paramType': 'NUMBER', 'timeFrame': '3 weeks of abstinence during 14 weeks of trial or for length of participation', 'description': 'Cocaine use was assessed by using urine toxicology confirmed self-report. Self-reported cocaine use data was collected for each day of the study period by the Time Line Follow Back. Urine samples were collected three times per week. A week was considered abstinence if no cocaine use was self reported during that week and if all urine samples collected that week were negative for cocaine. If a patient achieved three continuous weeks of abstinence based on this criteria they were considered cocaine abstinent in terms of this outcome measure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adderall-XR and Topiramate', 'description': 'Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo daily dose'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed all 14 week sof trial', 'groupId': 'FG000', 'numSubjects': '28'}, {'comment': 'Completed all 14 week sof trial', 'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}], 'recruitmentDetails': 'Participants were recruited by local advertising (internet, print, radio, television, and subway) or by clinical referrals in the New York City metropolitan area between January 2007 and February 2010.', 'preAssignmentDetails': 'Prior to group assignment patients participated in a one week placebo lead-in.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Adderall-XR and Topiramate', 'description': 'Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo daily dose'}, {'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': '39', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.5', 'spread': '8.2', 'groupId': 'BG000'}, {'value': '42.4', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '42.1', 'spread': '8.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-22', 'studyFirstSubmitDate': '2007-01-10', 'resultsFirstSubmitDate': '2012-12-13', 'studyFirstSubmitQcDate': '2007-01-11', 'lastUpdatePostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-01-23', 'studyFirstPostDateStruct': {'date': '2007-01-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Three Weeks of Continuous Cocaine Abstinence as Measured by Urine Toxicology and Self Report Based on Time Line Follow Back', 'timeFrame': '3 weeks of abstinence during 14 weeks of trial or for length of participation', 'description': 'Cocaine use was assessed by using urine toxicology confirmed self-report. Self-reported cocaine use data was collected for each day of the study period by the Time Line Follow Back. Urine samples were collected three times per week. A week was considered abstinence if no cocaine use was self reported during that week and if all urine samples collected that week were negative for cocaine. If a patient achieved three continuous weeks of abstinence based on this criteria they were considered cocaine abstinent in terms of this outcome measure.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cocaine', 'Adderall', 'Topiramate', 'ADHD'], 'conditions': ['Cocaine Dependence']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.stars.columbia.edu/', 'label': 'Substance Treatment and Research Service of Columbia University'}]}, 'descriptionModule': {'briefSummary': 'The proposed protocol is a double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (ER-MAS) and topiramate in the treatment of cocaine dependence. Since both of these medications have independently shown promise in helping with cocaine abuse we are proposing that together they may be even more successful in the treatment of cocaine abuse. We plan to enroll 120 subjects in a 14-week trial. The primary objective of the study is to determine the efficacy of ER-MAS and topiramate in promoting cocaine abstinence among cocaine-dependent patients. This study includes free treatment for cocaine dependence that includes medication.', 'detailedDescription': 'Specific Aim 1: To determine the efficacy of ER-MAS and topiramate in promoting cocaine abstinence among cocaine-dependent patients.\n\nPrimary Hypothesis: The proportion of participants achieving sustained cocaine abstinence (via urine toxicology) for three consecutive weeks during the study will be significantly greater for the combined pharmacotherapies group compared to the placebo group.\n\nHypothesis 2: The proportion of urine samples negative for cocaine metabolites will be greater in the combined pharmacotherapies group compared to the placebo group.\n\nHypothesis 3: The pattern of cocaine use (amount of cocaine used per day in dollars and the number of using days per week), as measured by the time-line follow-back method, will show a greater reduction in use for the combined pharmacotherapies group compared to the placebo group.\n\nSpecific Aim 2: To determine the effect of ER-MAS and topiramate on cocaine craving among cocaine-dependent patients.\n\nHypothesis 4: Cocaine craving symptoms will be reduced to a greater degree in the combined pharmacotherapies group compared to the placebo group.\n\nSpecific Aim 3: To explore a set of related secondary outcomes (treatment retention, global functioning, HIV risk behavior) as well as moderators and mediators potentially reflective of mechanism of action.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Men and women between the ages of 18-60 who meet DSM-IV criteria for current cocaine dependence (DSM-IV-TR).\n2. Used cocaine at least four days in the past month, with at least weekly cocaine use.\n3. Must have a Body Mass Index (BMI) \\> 18 kg/m2\n4. Alcohol Breathalyzer (BraC) at consent of \\< 0.04%\n5. Individuals must be capable of giving informed consent and capable of complying with study procedures.\n6. Women of child bearing age will be included in the study provided that they are not pregnant, based on the results of a blood pregnancy test drawn at the time of screening. They must also agree to use a method of contraception with proven efficacy and agree not to become pregnant during the study. To confirm this, blood pregnancy tests will be repeated monthly. Women will be provided a full explanation of the potential dangers of pregnancy while on the study medication. If a woman becomes pregnant, the study medication will be discontinued.\n\nExclusion Criteria:\n\n1. Meets DSM-IV-TR criteria for bipolar disorder, Schizophrenia, or any psychotic disorder other than transient psychosis due to drug abuse\n2. Individuals with any current Axis I psychiatric disorder as defined by DSM-IV-TR supported by the SCID-I/P that in the investigator's judgment are unstable or would be disrupted by study medication or are likely to require pharmacotherapy during the study period.\n3. Individuals with current major depressive disorder.\n4. Individuals physiologically dependent on any other drugs (excluding nicotine or cannabis) which require medical intervention.\n5. Individuals with current psycho stimulant abuse or dependence.\n6. Individuals with current suicidal risk.\n7. Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms.\n8. Unstable physical disorders which might make participation hazardous such as uncontrolled hypertension (SBP \\> 150, DBP\\> 90, or HR \\> 100 when sitting quietly), acute hepatitis (patients with chronic mildly elevated transaminases \\< 3x upper limit of normal are acceptable), or uncontrolled diabetes.\n9. Individuals with a history of seizures\n10. History of allergic reaction to candidate medication (amphetamine and/or ER-MAS or topiramate).\n11. Women who are pregnant or nursing.\n12. Use of carbonic anhydrase inhibitors\\*\n13. History of glaucoma, kidney stones\\*\n14. History of failure to respond to a previous Adequate trial of either candidate medication for Cocaine dependence\n15. Currently being prescribed psychotropic medication by another physician (other than sleep medication)\n16. Individuals who are legally mandated (e.g., to avoid incarceration, monetary or other penalties, etc.) to participate in substance abuse treatment program -"}, 'identificationModule': {'nctId': 'NCT00421603', 'acronym': 'TACT', 'briefTitle': 'A Placebo-Controlled Study of Mixed Amphetamine Salts and Topiramate for the Treatment of Cocaine Dependence', 'organization': {'class': 'OTHER', 'fullName': 'New York State Psychiatric Institute'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study of Mixed Amphetamine Salts (Adderall-XR) and Topiramate for the Treatment of Cocaine Dependence', 'orgStudyIdInfo': {'id': '#5368'}, 'secondaryIdInfos': [{'id': 'R01DA022217', 'link': 'https://reporter.nih.gov/quickSearch/R01DA022217', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Adderall-XR and Topiramate', 'description': 'Adderall-XR (60 mg/day) and Topiramate (300mg/day)', 'interventionNames': ['Drug: Adderall-XR and Topiramate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Adderall-XR and Topiramate', 'type': 'DRUG', 'description': 'Adderall-XR 60mg/day and Topiramate 300mg/day', 'armGroupLabels': ['Adderall-XR and Topiramate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'STARS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Frances R Levin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York State Psychiatric Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Substance Use Disorder', 'investigatorFullName': 'Frances R Levin', 'investigatorAffiliation': 'National Institute on Drug Abuse (NIDA)'}}}}