Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-26 @ 10:26 PM
Study NCT ID:
NCT00385268
Status:
COMPLETED
Last Update Posted:
2020-07-10
First Post:
2006-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Trial of Acamprosate 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'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077443', 'term': 'Acamprosate'}], 'ancestors': [{'id': 'D013654', 'term': 'Taurine'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'helenp@mail.med.upenn.edu', 'phone': '215-222-3200', 'title': 'Dr. Helen Pettinati', 'phoneExt': '139', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Acamprosate', 'description': '1998mg/day for 8 weeks\n\nCognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.\n\nacamprosate : 1998 mg/dau fpr 8 weeks', 'otherNumAtRisk': 34, 'otherNumAffected': 13, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'placebo pills for 8 weeks\n\nCognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.\n\nplacebo : placebo pills', 'otherNumAtRisk': 26, 'otherNumAffected': 13, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Aches and Pains', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cocaine Use Over the Eight Week Trial as Measured by Twice Weekly Urine Drug Screen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acamprosate', 'description': '1998mg/day for 8 weeks\n\nCognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.\n\nacamprosate : 1998 mg/dau fpr 8 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo pills for 8 weeks\n\nCognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.\n\nplacebo : placebo pills'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.44', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.68', 'ciLowerLimit': '0.55', 'ciUpperLimit': '5.14', 'statisticalMethod': 'GEE model of repeated measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'GEE on repeated binary indicators of BE positive / negative test'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'cocaine abstinent weeks determined by all negative urine drug screens in each week (2 urine drug screens per week)', 'unitOfMeasure': 'cocaine abstinent weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acamprosate', 'description': '1998mg/day for 8 weeks\n\nCognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.\n\nacamprosate : 1998 mg/dau fpr 8 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'placebo pills for 8 weeks\n\nCognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.\n\nplacebo : placebo pills'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Acamprosate', 'description': '1998mg/day for 8 weeks\n\nCognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.\n\nacamprosate : 1998 mg/dau fpr 8 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'placebo pills for 8 weeks\n\nCognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.\n\nplacebo : placebo pills'}, {'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': '34', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '60', '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': '45.3', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '46.1', 'spread': '7.7', 'groupId': 'BG001'}, {'value': '45.5', 'spread': '7.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-24', 'studyFirstSubmitDate': '2006-10-06', 'resultsFirstSubmitDate': '2013-08-28', 'studyFirstSubmitQcDate': '2006-10-06', 'lastUpdatePostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-11-11', 'studyFirstPostDateStruct': {'date': '2006-10-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cocaine Use Over the Eight Week Trial as Measured by Twice Weekly Urine Drug Screen', 'timeFrame': '8 weeks', 'description': 'cocaine abstinent weeks determined by all negative urine drug screens in each week (2 urine drug screens per week)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cocaine'], 'conditions': ['Cocaine Dependence']}, 'descriptionModule': {'briefSummary': 'Trial to determine the safety, efficacy and tolerability of acamprosate for the treatment of cocaine dependence.', 'detailedDescription': "The primary objective of the trial is to evaluate the safety, tolerability and efficacy of acamprosate for the treatment of 60 treatment seeking cocaine dependent outpatients. The study will be an exploratory, double-blind, placebo-controlled 9-week trial, with a 2-cell design (30 subjects per cell) in which either 1998 mg/day of acamprosate (666 mg TID) or placebo will be given. Study medications will be given by medical practitioners, trained to provide NIAAA's COMBINE Medical Management. In addition, patients will receive weekly individual psychosocial treatment sessions utilizing Cognitive Behavioral Therapy (CBT) at the University of Pennsylvania Treatment Research Center (TRC).\n\nPrimary Hypotheses:\n\n1. Efficacy: Acamprosate-treated subjects will demonstrate less cocaine use during the medication/placebo treatment phase, compared to placebo-treated subjects. Cocaine use will be measured by self-report from the TLFB confirmed with urine assay for benzoylecgonine (BE)\n2. Safety and Tolerability: Acamprosate-treated subjects and placebo-treated subjects will report similar rates of adverse events, assessed by weekly evaluations, physical exams and laboratory testing.\n\nSecondary Hypotheses:\n\n1. Acamprosate-treated subjects, compared to placebo-treated subjects, will report less craving for cocaine, measured by lower scores on the Brief Substance Craving Scale (BSCS) (Somoza et al, 1995) and Multiple Choice Procedure (MCP) (Griffiths et al., 1993) during the medication treatment phase.\n2. Acamprosate-treated subjects, compared to placebo-treated subjects, will report fewer withdrawal symptoms, measured by the Cocaine Selective Severity Assessment (Kampman et al., 1998).\n3. Acamprosate-treated subjects, compared to placebo-treated subjects, will report fewer mood and anxiety symptoms, measured by the Hamilton Depression Rating Scale (HAM-D) (Hamilton, 1967), Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1969), and Clinical Global Impression Scale (CGI).\n4. Subjects who are highly acamprosate-adherent (\\>80% pills taken, verified by combining patient report with blister cards) will have more cocaine non-use days during the medication treatment phase, compared to those who are less acamprosate-adherent (\\<80% pills taken)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Male and females 18 years of age or older.\n2. Subject meets DSM-IV criteria for current diagnose of cocaine dependence, determined by The Structured Clinical Interview for DSM-IV (SCID-IV).\n3. Subject used cocaine in the past 30 days totaling at least $200 worth of cocaine. Cocaine use will be determined by utilizing the modified Timeline Followback, crosschecked with the ASI, which inquires about dollar amounts spent on drug use.\n4. Subject lives a commutable distance from the TRC and agrees to attend all research visits, including follow-up visits.\n5. Subject speaks, understands, and prints in English.\n6. Written informed consent signed by the subject.\n\nExclusion Criteria\n\n1. Subjects mandated to treatment based upon a legal decision or as a condition of employment.\n2. Subjects with evidence of current substance dependence other than cocaine, alcohol or nicotine dependence, as determined by the SCID-IV.\n3. Subjects who meets DSM-IV criteria for current alcohol dependence who require a medical alcohol detoxification.\n4. Requires treatment with any psychoactive medications, including any anti-seizure medications (with the exception of Benadryl used sparingly, if necessary, for sleep).\n5. Has a lifetime DSM-IV diagnosis of bipolar affective disorder, schizophrenia or any psychotic disorder, or organic mental disorder. Has current DSM-IV diagnosis of any other clinically significant psychiatric disorder that will interfere with study participation, as determined by the study physician or PI (Drs. Kyle Kampman, Charles Dackis and Helen Pettinati).\n6. Female subjects who are pregnant or lactating, or female subjects of childbearing potential who are not using acceptable methods of birth control. Acceptable methods of birth control include: barrier (diaphragm or condom) with spermicide, intrauterine progesterone contraceptive system, levonorgestrel implant, medroxyprogesterone acetate contraceptive injection, and oral contraceptives.\n7. Clinical laboratory tests (CBC, blood chemistries, urinalysis) outside normal limits that are clinically unacceptable to the Principal Investigator. EKG-1st degree heart block, sinus tachycardia, left axis deviation, and nonspecific ST or T wave changes are allowed; liver function tests \\[LFTs\\] \\< 5 x ULN are acceptable. Eligibility will be determined by most recent lab results collected prior to randomization.\n8. Subjects with impaired renal function as indicated by corrected creatinine clearance below 80 ml/min/70 kg as determined by the modified Cockcroft equation (Center for Disease Control, 1986).\n9. Subjects who have any disease of the gastrointestinal tract, liver or kidneys that could result in a possibility of altered metabolism or excretion of the study drug. As it is not possible to enumerate the many conditions which might impair absorption, metabolism, or excretion, the investigators will be guided by evidence such as: History of major gastrointestinal tract surgery (gastrectomy, gastrostomy, bowel resection, etc) or a history of an active peptic ulcer or chronic disease of the GI tract (ulcerative colitis, regional enteritis, or gastrointestinal bleeding).\n10. History of significant heart disease (an arrhythmia which required medication, angina pectoris, documented history of myocardial infarction, or heart failure).\n11. Known hypersensitivity to acamprosate.\n12. Subjects having participated in any investigational drug trial within 30 days prior to randomizing into the study.\n13. Subjects with any serious illnesses that may require hospitalization during the study, as determined by the study physician or PI (Drs. Kyle Kampman, Charles Dackis and Helen Pettinati).'}, 'identificationModule': {'nctId': 'NCT00385268', 'acronym': 'CAMPRAL', 'briefTitle': 'Pilot Trial of Acamprosate for the Treatment of Cocaine Dependence', 'nctIdAliases': ['NCT00295451'], 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'A Phase II, Double-Blind, Placebo-controlled, Pilot Trial of Acamprosate for the Treatment of Cocaine Dependence', 'orgStudyIdInfo': {'id': '803895'}, 'secondaryIdInfos': [{'id': 'P60DA005186', 'link': 'https://reporter.nih.gov/quickSearch/P60DA005186', 'type': 'NIH'}, {'id': 'DPMC', 'type': 'OTHER', 'domain': 'NIDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active medication Acamprosate', 'description': '1998mg/day for 8 weeks', 'interventionNames': ['Drug: acamprosate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo pills for 8 weeks', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'acamprosate', 'type': 'DRUG', 'otherNames': ['Campral'], 'description': '1998 mg/dau fpr 8 weeks', 'armGroupLabels': ['Active medication Acamprosate']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo pills', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Helen Pettinati, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kyle Kampman', 'investigatorAffiliation': 'University of Pennsylvania'}}}}