Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT01251393
Status:
COMPLETED
Last Update Posted:
2020-10-14
First Post:
2010-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Cocaine/Crack and Reduction of Compulsion With Biperiden
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': 'D001712', 'term': 'Biperiden'}, {'id': 'D011615', 'term': 'Psychotherapy, Group'}], 'ancestors': [{'id': 'D001643', 'term': 'Bridged Bicyclo Compounds'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D012960', 'term': 'Socioenvironmental Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'galduroz@unifesp.br', 'title': 'PhD José Carlos F. Galduróz', 'organization': 'Universidade Federal de São Paulo'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'No adverse event', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 0, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Biperiden', 'description': 'No adverse event', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Compulsion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biperiden', 'description': 'Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.\n\nBiperiden: Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Thirty volunteers will take three pills of Placebo (6mg/day) during two months.\n\nPlacebo: Thirty volunteers will take three pills of Placebo (6mg/day) during two months.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "We used an ANOVA for repeated measures, followed by Bonferroni's post-hoc test to evaluate the efficacy of biperiden in reducing consumption of cocaine/crack.", 'groupDescription': "We evaluated the normality (Kolmogorov's test) and homogeneity (Levene's test) of the sample.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': "The comparisons between the placebo and the biperiden groups at baseline were performed by means of the independent t-Test. We evaluated the normality (Kolmogorov's test) and homogeneity (Levene's test) of the sample.\n\nWe used an ANOVA for repeated measures, followed by Bonferroni's post-hoc test to evaluate the efficacy of biperiden in reducing consumption of cocaine/crack."}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The patients answered the Minnesota Cocaine Craving Scale (Halikas et al., 1991).\n\nINTENSITY: Evaluation of crack strength by cocaine in the previous week:\n\nZero (no craving)---------------------------- -----10 (Intense craving)\n\nRanges from 0 to 10 (zero = no craving; 10 intense craving). Using a rule starting from 0, we determine the number that corresponds to the compulsion. The farther from 0 the more intense the compulsion will be.\n\nFrequency of craving onset: How many times a day 0 time/day - check: 0 point\n\n1. time/day - check: 1 point\n2. times/day - check: 2 points\n3. to 5 times/day - check: 3 points\n\n6 to 10 times/day - check: 4 points 11 to 20 times/day - check: 5 points more than 20 times/day - check: 6 points\n\nRanges from 0 to 6 points (zero = no craving; 1-2 points: Light; 3-4 points: moderate; 5- 6: intense craving).\n\nThe sum of the points of the subscales provides the final score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total sample of 166 patients was evaluated during the project. Of that number, 55 did not fulfil the inclusion criteria. The main reasons for exclusion were the presence of clinical comorbidities (active hepatitis, tuberculosis under treatment and epilepsy) or psychiatric comorbidities.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Biperiden', 'description': 'Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.\n\nBiperiden: Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Thirty volunteers will take three pills of Placebo (6mg/day) during two months.\n\nPlacebo: Thirty volunteers will take three pills of Placebo (6mg/day) during two months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '44'}]}]}], 'preAssignmentDetails': '55 participants in the placebo group and 56 participants in the biperiden group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Biperiden', 'description': '55 participants took biperidene for 2 months.'}, {'id': 'BG001', 'title': 'Placebo', 'description': '55 participants took placebo for 2 months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.9', 'spread': '7.6', 'groupId': 'BG000'}, {'value': '31.5', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '32.2', 'spread': '7.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-18', 'studyFirstSubmitDate': '2010-11-30', 'resultsFirstSubmitDate': '2019-02-12', 'studyFirstSubmitQcDate': '2010-11-30', 'lastUpdatePostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-14', 'studyFirstPostDateStruct': {'date': '2010-12-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compulsion', 'timeFrame': '3 months', 'description': 'The patients answered the Minnesota Cocaine Craving Scale (Halikas et al., 1991).\n\nINTENSITY: Evaluation of crack strength by cocaine in the previous week:\n\nZero (no craving)---------------------------- -----10 (Intense craving)\n\nRanges from 0 to 10 (zero = no craving; 10 intense craving). Using a rule starting from 0, we determine the number that corresponds to the compulsion. The farther from 0 the more intense the compulsion will be.\n\nFrequency of craving onset: How many times a day 0 time/day - check: 0 point\n\n1. time/day - check: 1 point\n2. times/day - check: 2 points\n3. to 5 times/day - check: 3 points\n\n6 to 10 times/day - check: 4 points 11 to 20 times/day - check: 5 points more than 20 times/day - check: 6 points\n\nRanges from 0 to 6 points (zero = no craving; 1-2 points: Light; 3-4 points: moderate; 5- 6: intense craving).\n\nThe sum of the points of the subscales provides the final score.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cocaine', 'crack', 'treatment', 'dependence', 'biperiden'], 'conditions': ['Cocaine Dependence']}, 'descriptionModule': {'briefSummary': 'Considering the effects of the cholinergic system on the drug reward and self-administration mechanisms, acetylcholine (Ach) may play an important role on cocaine dependence process. Then the present study aims to evaluate biperiden efficacy (a cholinergic antagonist) in attenuate compulsion, one o the main symptoms of the drug dependence.', 'detailedDescription': 'Cocaine consumption affects around 13.4 mi people or 0.3% of the world population between 15 and 64 years old. The drug dependence has been described by many authors as a dysfunction of the brain reward system. Considering the effects of the cholinergic system on the drug reward and self-administration mechanisms, acetylcholine (Ach) may play an important role on cocaine dependence process. Then the present study aims to evaluate biperiden efficacy (a cholinergic antagonist) in attenuate compulsion, one o the main symptoms of the drug dependence. To accomplish this purpose 60 cocaine or crack male users between 18 and 50 years old will be study. This is a double-blind controlled and randomized placebo study. All the patients will be treated with brief intervention therapy (BIT), and half of them will receive biperiden (6mg/day) while the other half will receive placebo. The treatment efficacy will be evaluated through the comparison between the values obtained on the following measures before and after the treatment: Craving scale of Minnesota and Cocaine/crack consumption questionnaire, and the presence of the cocaine metabolite (benzoylecgonine) on urine.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cocaine or crack dependence, according to the DSM-IV criteria (APA, 1994)\n\nExclusion Criteria:\n\n* Being under treatment with psychoactive drugs\n* Have been diagnosed for other Psychiatric Disorders\n* Have dependence diagnosis for other drugs, except for tabacco'}, 'identificationModule': {'nctId': 'NCT01251393', 'briefTitle': 'Cocaine/Crack and Reduction of Compulsion With Biperiden', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Cocaine/Crack Dependence: A Study of the Possible Reduction of Compulsion Under the Use of Biperiden', 'orgStudyIdInfo': {'id': 'ACJC2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biperiden', 'description': 'Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.', 'interventionNames': ['Drug: Biperiden']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Thirty volunteers will take three pills of Placebo (6mg/day) during two months.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Biperiden', 'type': 'DRUG', 'otherNames': ['Group psychotherapy'], 'description': 'Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.', 'armGroupLabels': ['Biperiden']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Group psychotherapy'], 'description': 'Thirty volunteers will take three pills of Placebo (6mg/day) during two months.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04024-003', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'UDED - Drug Dependence Unit', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'José C F. Galduróz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal de São Paulo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nacional Conseling of Scientific Development and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Jose Carlos Fernandes Galduroz MD', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}