Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-24 @ 8:47 AM
Study NCT ID:
NCT02111551
Status:
TERMINATED
Last Update Posted:
2016-06-16
First Post:
2014-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Nicotinic Agonist Treatment Trial for Autism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C088936', 'term': '3-(2,4-dimethoxybenzylidene)anabaseine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'difficult to find participants and no funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-14', 'studyFirstSubmitDate': '2014-04-04', 'studyFirstSubmitQcDate': '2014-04-08', 'lastUpdatePostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between drug and placebo on theTotal Scale Score on the repeatable Battery for the Assessment of neuropsychological Status at 2 hours after administration', 'timeFrame': '2 hours after drug administration'}, {'measure': 'Difference between drug and placebo on the CPT at 30 minutes after administration', 'timeFrame': '30 minutes after drug administration'}, {'measure': 'Difference between the P50 auditory evoked potential test/conditioning ratio 1 hour after administration', 'timeFrame': '1 hour after drug administration'}, {'measure': 'Difference between placebo and drug on the Social Responsiveness scale 2 hours after administration', 'timeFrame': '2 hours after drug administration'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Autism', 'Nicotinic agonist', 'Cognition', 'P50', 'Alpha 7'], 'conditions': ['Autism']}, 'referencesModule': {'references': [{'pmid': '18381905', 'type': 'BACKGROUND', 'citation': 'Freedman R, Olincy A, Buchanan RW, Harris JG, Gold JM, Johnson L, Allensworth D, Guzman-Bonilla A, Clement B, Ball MP, Kutnick J, Pender V, Martin LF, Stevens KE, Wagner BD, Zerbe GO, Soti F, Kem WR. Initial phase 2 trial of a nicotinic agonist in schizophrenia. Am J Psychiatry. 2008 Aug;165(8):1040-7. doi: 10.1176/appi.ajp.2008.07071135. Epub 2008 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'This study plans to learn more about whether a nicotine-like investigational new drug, DMXB-A \\[3-(2,4-dimethoxybenzylidene) anabaseine\\] may have positive effects on mental focus and may help us to find new types of treatment for autism spectrum disorder. Subjects will come in for a screening visit and three more drug visits. There will be at least one week between each drug visit to allow the drug to be eliminated from your system completely. During each drug visit subjects will receive either a placebo (a capsule that looks like medicine but is not real), 75 mg of DMXB-A, or 150 mg of DMXB-A. During the drug day vital signs and well being will be monitored by the study physician. Subjects will complete some paper and pencil tasks to test memory, attention, speed, and problem solving, some rating scales and questionnaires, and the study team will record brain wave patterns with an electroencephalogram (EEG) .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-50\n* meet DSM-5 criteria for Autism Spectrum Disorder, Levels 1 or 2, as defined by Autism Diagnostic Observation Schedule\n* non-smoking persons\n* in good health\n\nExclusion Criteria:\n\n* persons with estimated verbal and nonverbal IQ \\< 70.\n* abuse of other substances.\n* Persons not sufficiently fluent in English to permit testing\n* those with history of severe head injury\n* Fragile X Syndrome\n* Rett Syndrome'}, 'identificationModule': {'nctId': 'NCT02111551', 'briefTitle': 'Phase I Nicotinic Agonist Treatment Trial for Autism', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Phase I Nicotinic Agonist Treatment Trial for Autism', 'orgStudyIdInfo': {'id': '14-0614'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DMXB-A 75 mg', 'description': 'DMXB-A 75 mg dose followed by a second dose of 37.5 mg at 2 hours to maintain the blood level', 'interventionNames': ['Drug: DMXB-A 150 mg', 'Other: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'DMXB-A 150 mg', 'description': 'DMXB-A 150 mg followed by a second dose of 75 mg at 2 hours to maintain the blood level', 'interventionNames': ['Other: placebo', 'Drug: DMXB-A 75 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar Pill', 'description': 'placebo comparator dose followed by a second placebo dose at 2 hours to maintain blind', 'interventionNames': ['Drug: DMXB-A 150 mg', 'Drug: DMXB-A 75 mg']}], 'interventions': [{'name': 'DMXB-A 150 mg', 'type': 'DRUG', 'armGroupLabels': ['DMXB-A 75 mg', 'Sugar Pill']}, {'name': 'placebo', 'type': 'OTHER', 'armGroupLabels': ['DMXB-A 150 mg', 'DMXB-A 75 mg']}, {'name': 'DMXB-A 75 mg', 'type': 'DRUG', 'armGroupLabels': ['DMXB-A 150 mg', 'Sugar Pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Robert Freedman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}