Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT02726035
Status:
WITHDRAWN
Last Update Posted:
2017-11-06
First Post:
2016-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Naltrexone as a Treatment for Self-injurious Behavior
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D012652', 'term': 'Self Mutilation'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009271', 'term': 'Naltrexone'}], 'ancestors': [{'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI deceased', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-31', 'studyFirstSubmitDate': '2016-03-18', 'studyFirstSubmitQcDate': '2016-03-28', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of self-injury rates by condition', 'timeFrame': 'For each 3 week trial, average rates calculated over weeks 2-3 only (14 day period).', 'description': 'naltrexone rate vs. placebo rate'}], 'secondaryOutcomes': [{'measure': 'Comparison of self-injury rates by trial within condition', 'timeFrame': 'Average rates calculated for weeks 2-3 of each 3 week trial (14 day period)', 'description': '1st naltrexone trial vs. 2nd \\& 1st placebo trial vs. 2nd'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Self-injurious behavior', 'Self mutilation', 'naltrexone'], 'conditions': ['Self-injurious Behavior', 'Self Mutilation']}, 'descriptionModule': {'briefSummary': 'The proposed study examines the effect of oral naltrexone on self-injurious behavior (SIB) in adolescents and adults of normal intelligence.', 'detailedDescription': 'The proposed study examines the effect of oral naltrexone on self-injurious behavior (SIB) in adolescents and adults of normal intelligence. It is designed as a pilot study and will provide preliminary data for a larger scale clinical trial if found to be effective in the pilot study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Thirteen years of age or older\n* Actively engaged in SIB at a rate of, on average, at least two events per week for at least 3 months\n* Has internet access in a secure and private manner\n* Lives within a reasonable distance from Kalamazoo (to make the five clinic visits convenient) and plans to remain in the area throughout the next 4-5 months\n\nExclusion Criteria:\n\n* Under the age of 13\n* Currently pregnant (confirmed with initial urine pregnancy test), lactating, or planning to become pregnant in the next 4 months\n* Active hepatitis or liver disease\n* Prior history of recently active opioid dependence\n* Current prescription, non-prescription, or illicit opioid use, (i.e., acute use within the past 14 days or chronic use within the last 30 days), including all opioid analgesics, certain cough and cold remedies (e.g., codeine), and certain anti-diarrheal preparations (e.g., loperamide). Currently taking an opioid antagonist for alcohol or opioid dependence or having taken one in the last 14 days\n* Current use of leflunomide (Arava), droperidol (Droleptan), diazepam (Valium), thioridazine (Mellaril, Novoridazine, Thioril) (26)\n* Any report of clinically significant medical condition or medication regimen which might cause undue risk or affect ability to participate in this clinical trial\n* On initial laboratory examination, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels more than one standard deviation (SD) above the upper limit of normal\n* Unable to meet a 22-week requirement to log journal entries daily, to be available by phone a minimum of once weekly during the first month, and to be present at clinical sites once every three weeks for 12 weeks, for a total of 5 visits\n* Infrequent SIB, lack of secure Internet access, or living a significant distance from the Kalamazoo area (does not meet inclusion criteria)\n* Unwilling or parent/guardian unwilling to participate in research requirements.'}, 'identificationModule': {'nctId': 'NCT02726035', 'acronym': 'NTX-SIB', 'briefTitle': 'Evaluation of Naltrexone as a Treatment for Self-injurious Behavior', 'organization': {'class': 'OTHER', 'fullName': 'Western Michigan University School of Medicine'}, 'officialTitle': 'Evaluation of Naltrexone as a Treatment for Self-Injurious Behavior', 'orgStudyIdInfo': {'id': 'BorgessIRB-2014-0672'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 A-ABAB', 'description': 'After 4 week open label oral naltrexone run-in, participants are randomized to 2 groups (50% each). Group 1 will receive oral naltrexone 50 mg daily during weeks 5-7 (3 weeks). They will switch to placebo for weeks 8-10, then return to naltrexone for weeks 11-13, then placebo for weeks 14-16 (i.e., A-ABAB double crossover design, participants act as own controls). Study drug and placebo will be encapsulated so as to appear identical.', 'interventionNames': ['Drug: Naltrexone', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 A-BABA', 'description': 'After 4 week open label oral naltrexone run-in, participants are randomized to 2 groups (50% each). Group 2 will receive oral placebo once daily during weeks 5-7. They will then be switched to oral naltrexone 50 mg daily for weeks 8-10, then return to placebo for weeks 11-13, then naltrexone for weeks 14-16 (i.e., A-BABA double crossover design, participants act as own controls). Study drug and placebo will be encapsulated so as to appear identical.', 'interventionNames': ['Drug: Naltrexone', 'Other: Placebo']}], 'interventions': [{'name': 'Naltrexone', 'type': 'DRUG', 'otherNames': ['Revia'], 'description': 'oral naltrexone 50 mg daily', 'armGroupLabels': ['Group 1 A-ABAB', 'Group 2 A-BABA']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'oral placebo (appearing identical to naltrexone) once daily', 'armGroupLabels': ['Group 1 A-ABAB', 'Group 2 A-BABA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49048', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Borgess Research Institute', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}], 'overallOfficials': [{'name': 'Michael R. Liepman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western Michigan University School of Medicine'}, {'name': 'Chris A. Karampahtsis, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western Michigan University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western Michigan University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kalamazoo Community Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}