Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-03-02 @ 4:02 PM
Study NCT ID:
NCT00628927
Status:
COMPLETED
Last Update Posted:
2015-12-30
First Post:
2008-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Eval of Neurocognitive Function, Oxidative Damage, and Their Association With Outcomes in METH and Cocaine Abusers.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'winhusen@carc.uc.edu', 'phone': '513-487-7800', 'title': 'Dr. Theresa Winhusen', 'organization': 'University of Cincinnati'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Simulant Dependent Participants', 'description': 'Stimulant Dependent pts entering treatment who are also enrolled in CTN0031', 'otherNumAtRisk': 175, 'otherNumAffected': 0, 'seriousNumAtRisk': 175, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Normal Control Participants', 'description': 'Normal Control participants recruited from the community', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Stroop Color-word Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stimulant Dependent Completers', 'description': 'Completers were those who attended the first 5 weeks of treatment without missing two or more consecutive weeks; a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment completer if s/he attended treatment during the sixth week'}, {'id': 'OG001', 'title': 'Stimulant Dependent Treatment Non-Completers', 'description': 'Non-completers were those who failed to attend the first 5 weeks of treatment without missing two or more consecutive weeks; alternately, a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment non-completer if s/he did not attend treatment during the sixth week Data for the two ineligible but enrolled participants was removed from the analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.4', 'spread': '22.9', 'groupId': 'OG000'}, {'value': '50.5', 'spread': '21.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single study visit', 'description': "The primary objective of this study was to replicate the finding that performance on the Stroop color-word interference task is predictive of treatment completion in participants with cocaine use disorders (Streeter et al., 2007) and to extend this finding to participants with methamphetamine use disorders. In the Stroop, the participant is required to name the color of the ink in which a word is printed while inhibiting the overlearned response of reading the word (e.g., the word ''red'' might be printed in blue ink). The number of errors were subtracted from the time required (RT; Reaction Time) for each of the 3 trials, yielding three summary scores. The derived interference score is obtained by subtracting the RT for the first trial from the RT for the third trial.", 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Barrett Impulsiveness Scale Version 11 (BIS-11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stimulant Dependent Completers', 'description': 'Completers were those who attended the first 5 weeks of treatment without missing two or more consecutive weeks; a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment completer if s/he attended treatment during the sixth week Data from one participant was excluded from analysis due to lack of completeness'}, {'id': 'OG001', 'title': 'Stimulant Dependent Treatment Non-Completers', 'description': 'Non-completers were those who failed to attend the first 5 weeks of treatment without missing two or more consecutive weeks; alternately, a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment non-completer if s/he did not attend treatment during the sixth week Data from the two ineligible by enrolled participants was removed from the analysis.\n\nData from 3 other participants was incomplete and therefore removed from the analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '69.4', 'spread': '7.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single study visit', 'description': 'The BIS-11 consists of 30 self-report items, with responses in a four-point Likert-type scale (0 - 3)ranging from "Rarely/Never" to "Almost Always/Always" and comprises three domains: Attentional impulsiveness (AI), Motor impulsiveness (MI), and Non-planning impulsiveness (NP); these three domains are summed to yield a total score; higher scores reflect greater impulsivity. The total score was utilized as the BIS-11 predictor measure (possible score range 0 - 90).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tail Length From the Comet Assay for Oxidative Damage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Stimulant Dependent Completers', 'description': 'Completers were those who attended the first 5 weeks of treatment without missing two or more consecutive weeks; a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment completer if s/he attended treatment during the sixth week 3 participant samples were insufficient for analysis'}, {'id': 'OG001', 'title': 'Stimulant Dependent Treatment Non-Completers', 'description': 'Non-completers were those who failed to attend the first 5 weeks of treatment without missing two or more consecutive weeks; alternately, a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment non-completer if s/he did not attend treatment during the sixth week Data for 2 participants who were ineligible but enrolled were removed from analysis 1 participant did not complete the blood draw\n\n1 participant sample was insufficient for analysis'}, {'id': 'OG002', 'title': 'Normal Controls', 'description': 'Normal controls recruited from the community.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.3', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '15.6', 'spread': '8.5', 'groupId': 'OG001'}, {'value': '16.5', 'spread': '7.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single study visit', 'description': 'The test for oxidative damage was derived from a blood sample which was analyzed for tail length from the comet assay; higher scores reflect greater oxidative damage.', 'unitOfMeasure': 'µm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Simulant Dependent Participants', 'description': 'Stimulant Dependent pts entering treatment who are also enrolled in CTN0031'}, {'id': 'FG001', 'title': 'Normal Control Participants', 'description': 'Normal Control participants recruited from the community'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '183'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '175'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Problems performing blood draw', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Equipment failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'As an ancillary study to CTN-0031, six of the nine sites participating in CTN-0031 were chosen to participate in the present study. At the participating sites, participants who were randomized into CTN-0031 were eligible to be screened for the present study. Normal controls were recruited via advertising from one study site.', 'preAssignmentDetails': '6 stimulant abusers met at least one exclusion criterion, 3 for a history of stroke and 3 for a history of seizures. 2 of those 6 were incorrectly enrolled into the study. The most common exclusion criteria met by the normal control screeners was having a DSM-IV substance use diagnosis and positive urine toxicology screen.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Simulant Dependent Participants', 'description': 'Stimulant Dependent pts entering treatment who are also enrolled in CTN0031'}, {'id': 'BG001', 'title': 'Normal Control Participants', 'description': 'Normal Control participants recruited from the community'}, {'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': '183', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '213', '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': '38.6', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '44.5', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '39.4', 'spread': '9.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Stimulant dependent participants were starting treatment, and participating in the CTN0031 study. Normal controls were recruited from the community.'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood sample for the oxidative stress/damage analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 217}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-01', 'studyFirstSubmitDate': '2008-03-03', 'resultsFirstSubmitDate': '2013-05-03', 'studyFirstSubmitQcDate': '2008-03-03', 'lastUpdatePostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-22', 'studyFirstPostDateStruct': {'date': '2008-03-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stroop Color-word Task', 'timeFrame': 'Single study visit', 'description': "The primary objective of this study was to replicate the finding that performance on the Stroop color-word interference task is predictive of treatment completion in participants with cocaine use disorders (Streeter et al., 2007) and to extend this finding to participants with methamphetamine use disorders. In the Stroop, the participant is required to name the color of the ink in which a word is printed while inhibiting the overlearned response of reading the word (e.g., the word ''red'' might be printed in blue ink). The number of errors were subtracted from the time required (RT; Reaction Time) for each of the 3 trials, yielding three summary scores. The derived interference score is obtained by subtracting the RT for the first trial from the RT for the third trial."}], 'secondaryOutcomes': [{'measure': 'Barrett Impulsiveness Scale Version 11 (BIS-11)', 'timeFrame': 'Single study visit', 'description': 'The BIS-11 consists of 30 self-report items, with responses in a four-point Likert-type scale (0 - 3)ranging from "Rarely/Never" to "Almost Always/Always" and comprises three domains: Attentional impulsiveness (AI), Motor impulsiveness (MI), and Non-planning impulsiveness (NP); these three domains are summed to yield a total score; higher scores reflect greater impulsivity. The total score was utilized as the BIS-11 predictor measure (possible score range 0 - 90).'}, {'measure': 'Tail Length From the Comet Assay for Oxidative Damage', 'timeFrame': 'Single study visit', 'description': 'The test for oxidative damage was derived from a blood sample which was analyzed for tail length from the comet assay; higher scores reflect greater oxidative damage.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Stimulant Dependence']}, 'referencesModule': {'references': [{'pmid': '22771145', 'type': 'RESULT', 'citation': 'Winhusen TM, Somoza EC, Lewis DF, Kropp FB, Horigian VE, Adinoff B. Frontal systems deficits in stimulant-dependent patients: evidence of pre-illness dysfunction and relationship to treatment response. Drug Alcohol Depend. 2013 Jan 1;127(1-3):94-100. doi: 10.1016/j.drugalcdep.2012.06.017. Epub 2012 Jul 6.'}, {'pmid': '23808868', 'type': 'DERIVED', 'citation': 'Winhusen T, Walker J, Brigham G, Lewis D, Somoza E, Theobald J, Somoza V. Preliminary evaluation of a model of stimulant use, oxidative damage and executive dysfunction. Am J Drug Alcohol Abuse. 2013 Jul;39(4):227-34. doi: 10.3109/00952990.2013.798663. Epub 2013 Jun 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether performance on neurocognitive measures predicts treatment outcomes in individuals with substance abuse disorders. A second purpose is to compare the risk of damage, as well as actual damage, to DNA and other cell parts in people with substance abuse disorders to that of people who do not have substance abuse disorders.', 'detailedDescription': 'The primary objective of this study is to replicate the finding that performance on the Stroop color-word interference task is predictive of treatment completion in participants with cocaine use disorders and to extend this finding to participants with Methamphetamine use disorders. Secondary objectives include evaluating whether:\n\n1. performance on various neurocognitive measures, including the Stroop, Rey Auditory-Verbal Learning Test (RAVLT), Iowa Gambling Task (GT), Wisconsin Card Sorting Task (WCST), the Barratt Impulsiveness Scale version -11 (BIS-11), and the Frontal Systems Behavior Scale (FrSBe) is predictive of treatment attrition and stimulant use outcomes in METH/cocaine abusers;\n2. neurocognitive test performance is associated with oxidative damage, a severe consequence of oxidative stress, in METH/cocaine abusers;\n3. oxidative damage is predictive of treatment attrition and substance use outcomes in METH/cocaine abusers,\n4. oxidative damage in METH/cocaine abusers is significantly greater than that of a normal comparison group and\n5. exploratory analyses reveal a significant relationship among oxidative stress, neurocognitive function, and treatment outcomes in METH/cocaine abusers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Persons randomized into the National Drug Abuse Treatment Clinical Trials Network STAGE-12 Study (CTN-0031- NCT00573183)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (METH and/or Cocaine Dependent Group):\n\n* be randomized into the CTN-0031 (STAGE-12) trial\n* current abuse or dependence for METH and/or cocaine\n* endorse METH and/or cocaine as the primary drug of choice\n* able to correctly distinguish the colored stimuli on the Stoop task.\n\nExclusion Criteria (METH and/or Cocaine Dependent Group):\n\n* history of stroke\n* history of a seizure disorder\n\nInclusion Criteria (Non-METH and/or Cocaine Dependent Group):\n\n* be 18 years of age or older\n* be able to understand the study and provide written informed consent in English\n\nExclusion Criteria (Non-METH and/or Cocaine Dependent Group):\n\n* history of stroke\n* history of a seizure disorder\n* positive urine toxicology screen\n* screen positive for Major Depressive Syndrome, other Depressive Syndrome, Panic Syndrome, or other Anxiety Syndrome\n* meet criteria for ADHD\n* have HIV/AIDS\n* history of an injury in which consciousness was lost for more than 30 minutes\n* meet DSM-IV criteria for dependence (either current or lifetime) for any psychoactive substance other than nicotine or for abuse (both current and lifetime) for any psychoactive substance other than nicotine or for alcohol for which a life-time history of abuse is allowed'}, 'identificationModule': {'nctId': 'NCT00628927', 'briefTitle': 'An Eval of Neurocognitive Function, Oxidative Damage, and Their Association With Outcomes in METH and Cocaine Abusers.', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'An Evaluation of Neurocognitive Function, Oxidative Damage, and Their Association With Treatment Outcomes in Methamphetamine and Cocaine Abusers', 'orgStudyIdInfo': {'id': 'NIDA-CTN-0031A'}, 'secondaryIdInfos': [{'id': '5U10DA013732', 'link': 'https://reporter.nih.gov/quickSearch/5U10DA013732', 'type': 'NIH'}, {'id': 'U10DA013732', 'link': 'https://reporter.nih.gov/quickSearch/U10DA013732', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'METH and/or cocaine dependent group', 'description': 'The METH and/or cocaine dependent group were also enrolled in CTN0031 (NCT00573183) and seeking treatment. This group will be analyzed based on whether or not they completed treatment as defined by the study.'}, {'label': 'Non METH and/or cocaine dependent group', 'description': 'The Non METH and/or cocaine dependent group participants are normal controls recruited from the community.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32211', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Gateway Community Services', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '43207', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Maryhaven', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97402', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Willamette Family Treatment Services', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '97292', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'ChangePoint, Inc.', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '75228', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Nexus Recovery Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Recovery Centers of King County', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Theresa Winhusen, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Theresa Winhusen', 'investigatorAffiliation': 'University of Cincinnati'}}}}