Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-31 @ 2:06 AM
Study NCT ID:
NCT01684293
Status:
COMPLETED
Last Update Posted:
2019-07-01
First Post:
2012-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Occupational Therapy-Based Cognitive Rehabilitation of Cocaine Abusers: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-28', 'studyFirstSubmitDate': '2012-09-10', 'studyFirstSubmitQcDate': '2012-09-10', 'lastUpdatePostDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in cognitive impairment', 'timeFrame': 'baseline through 6 months', 'description': 'Global Deficit Score, range 0 (no impairment) to 5 (severe impairment)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cocaine', 'Cognitive Impairment', 'Cognitive Rehabilitation'], 'conditions': ['Mild Cognitive Impairment, So Stated', 'Cocaine Use Disorder']}, 'descriptionModule': {'briefSummary': 'This study integrates a model of occupational-therapy based cognitive rehabilitation as part of a comprehensive treatment plan for cocaine abusers. We hypothesize that cognitive impairment and quality of life would improve and that cocaine use would decrease in those participants receiving occupational-therapy based cognitive rehabilitation.', 'detailedDescription': 'occupational-therapy based cognitive rehabilitation as part of a comprehensive treatment plan for cocaine abusers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 18-65\n2. Primary cocaine use disorder (based on DSM-5 criteria) and in at least 3 months of remission\n3. At least mild cognitive impairment, defined as = or \\> 1.5 standard deviations impairment on any 2 performance-based neurocognitive measures\n4. Needing to change quality of life, defined as self-identifying at least 2 life areas as needing to change on the Drug User Quality of Life Scale\n5. A Veteran at the San Francisco Veterans Affairs Medical Center\n6. Currently receiving weekly drug counseling (individual or group; at least 1 hour/week) through an outpatient substance use disorder treatment program\n\nExclusion Criteria:\n\n1. Inability to speak, read, write, and understand English\n2. Inadequate hearing or vision\n3. Concurrent substance use disorder (except tobacco or caffeine) not in at least 3 months of remission\n4. A psychiatric disorder that will interfere with study participation or will make participation hazardous (e.g., psychosis, suicidal or homicidal ideations, severe anxiety)\n5. A depressive disorder classified as severe, defined as a Beck Depression Inventory-II score \\>29\n6. Current diagnosis of a bipolar disorder needing acute inpatient psychiatric hospitalization\n7. Currently symptomatic from attention-deficit/hyperactivity disorder (DSM-5 criteria)\n8. Any learning disorder, any type of dementia, any type of delirium, or an amnestic disorder due to any general medical condition\n9. Wechsler Test of Adult Reading standard score \\<70\n10. Mini-Mental State Examination score \\<24\n11. Current use of scheduled (i.e., prescribed) regular (i.e., daily) psychotropics or other medicines with a high likelihood of sedation \\& cognitive impairment (e.g., benzodiazepines, clozapine, anticholinergics)\n12. Currently prescribed stimulants (e.g., methylphenidate) or cognitive enhancers (e.g., donepezil, memantine)\n13. Active medical illnesses - uncontrolled diabetes, uncontrolled hypertension, uncontrolled thyroid dysfunction, or uncontrolled B12/folate deficiency; central nervous system illness with potential cognitive aspects (Parkinson's, or Huntington's dementia); Cirrhosis with complications (e.g., ascites, encephalopathy, jaundice, gastrointestinal bleeding); Needing acute medical hospitalization from HIV sequelae, such as HIV-related opportunistic infection\n14. Any history of any type of stroke or brain hemorrhage\n15. Any history of traumatic brain injury, intracranial pathology (e.g., tumor), or brain surgery\n16. Currently on probation or parole\n17. Concurrent participation in another study that medically/administratively interferes with this study"}, 'identificationModule': {'nctId': 'NCT01684293', 'briefTitle': 'Occupational Therapy-Based Cognitive Rehabilitation of Cocaine Abusers: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Occupational Therapy-Based Cognitive Rehabilitation of Cocaine Abusers: A Pilot Study', 'orgStudyIdInfo': {'id': '5K23DA034883-02', 'link': 'https://reporter.nih.gov/quickSearch/5K23DA034883-02', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Rehabilitation', 'description': 'Occupational therapy-based cognitive rehabilitation', 'interventionNames': ['Behavioral: Occupational therapy-based cognitive rehabilitation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Psychoeducation/games', 'description': 'Psychoeducation/games', 'interventionNames': ['Behavioral: Psychoeducation/games']}], 'interventions': [{'name': 'Occupational therapy-based cognitive rehabilitation', 'type': 'BEHAVIORAL', 'description': 'Occupational therapy-based cognitive rehabilitation', 'armGroupLabels': ['Cognitive Rehabilitation']}, {'name': 'Psychoeducation/games', 'type': 'BEHAVIORAL', 'description': 'Psychoeducation/games', 'armGroupLabels': ['Psychoeducation/games']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco & San Francisco Veterans Affairs Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Raj K Kalapatapu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'San Francisco Veterans Affairs Medical Center', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}