Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2025-12-31 @ 11:21 AM
Study NCT ID:
NCT00719095
Status:
COMPLETED
Last Update Posted:
2013-04-15
First Post:
2008-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effective Treatment for Prescription Opioid Abuse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-09-17', 'releaseDate': '2014-09-10'}], 'estimatedResultsFirstSubmitDate': '2014-09-10'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001521', 'term': 'Behavior Therapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-12', 'studyFirstSubmitDate': '2008-07-17', 'studyFirstSubmitQcDate': '2008-07-17', 'lastUpdatePostDateStruct': {'date': '2013-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of subjects abstinent from all opioids through the final day of detoxification', 'timeFrame': 'up to 12-week trial'}], 'secondaryOutcomes': [{'measure': 'percentage of subjects retained in treatment through the final day of detoxification', 'timeFrame': 'up to 12-week trial'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prescription opioid', 'opioid detoxification', 'buprenorphine', 'naltrexone', 'community reinforcement approach', 'prescription opioid abuse'], 'conditions': ['Prescription Opioid Dependence']}, 'referencesModule': {'references': [{'pmid': '24153411', 'type': 'DERIVED', 'citation': 'Sigmon SC, Dunn KE, Saulsgiver K, Patrick ME, Badger GJ, Heil SH, Brooklyn JR, Higgins ST. A randomized, double-blind evaluation of buprenorphine taper duration in primary prescription opioid abusers. JAMA Psychiatry. 2013 Dec;70(12):1347-54. doi: 10.1001/jamapsychiatry.2013.2216.'}]}, 'descriptionModule': {'briefSummary': 'There has been an alarming increase in abuse of prescription opioids in recent years. This project aims to develop an effective outpatient treatment for prescription opioid (PO) abuse that combines an intensive behavioral therapy with a pharmacotherapy regimen of buprenorphine detoxification and naltrexone maintenance.', 'detailedDescription': 'There has been an alarming increase in abuse of prescription opioids in recent years. This project aims to develop an effective outpatient treatment for prescription opioid (PO) abuse that combines an intensive behavioral therapy with a pharmacotherapy regimen of buprenorphine detoxification and naltrexone maintenance. Aim 1) Conduct a randomized, three-parallel-groups clinical trial (Study 1) to determine a buprenorphine dose-tapering schedule that prevents the poor retention and relapse that undermine many opioid detoxification regimens. Aim 2) Conduct a randomized, three-parallel-groups clinical trial (Study 2) to determine a duration of naltrexone therapy that sustains opioid abstinence following the buprenorphine detoxification.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For inclusion in the proposed studies, subjects must be \\> 18 years old and in good health. Subjects must meet DSM-IV criteria for opioid dependence and FDA qualification criteria for buprenorphine treatment, including a history of opioid dependence and significant current opioid use (i.e., opioid-positive urines). Subjects must also be seeking or willing to accept opioid detoxification.\n\nExclusion Criteria:\n\n* Because the primary focus of the proposed research is to develop an efficacious intervention for prescription opioid abuse that employs a buprenorphine taper and subsequent naltrexone maintenance, individuals who require ongoing opioid therapy for pain or other chronic medical conditions will be excluded from participating.\n* Individuals with evidence of an active psychiatric disorder that may interfere with consent or participation in the research (e.g., psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g., cardiovascular disease) or who are pregnant or nursing will be excluded from participation.'}, 'identificationModule': {'nctId': 'NCT00719095', 'briefTitle': 'Effective Treatment for Prescription Opioid Abuse', 'organization': {'class': 'OTHER', 'fullName': 'University of Vermont Medical Center'}, 'officialTitle': 'Effective Treatment for Prescription Opioid Abuse', 'orgStudyIdInfo': {'id': 'R01DA019989', 'link': 'https://reporter.nih.gov/quickSearch/R01DA019989', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01DA019989', 'link': 'https://reporter.nih.gov/quickSearch/R01DA019989', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1-week buprenorphine taper', 'description': '1-week buprenorphine taper + behavioral therapy + urine toxicology', 'interventionNames': ['Drug: buprenorphine taper followed by naltrexone maintenance', 'Behavioral: Behavioral therapy']}, {'type': 'EXPERIMENTAL', 'label': '2-week buprenorphine taper', 'description': '2-week buprenorphine taper + behavioral therapy + urine toxicology', 'interventionNames': ['Drug: buprenorphine taper followed by naltrexone maintenance', 'Behavioral: Behavioral therapy']}, {'type': 'EXPERIMENTAL', 'label': '4-week buprenorphine taper', 'description': '4-week buprenorphine taper + behavioral therapy + urine toxicology', 'interventionNames': ['Drug: buprenorphine taper followed by naltrexone maintenance', 'Behavioral: Behavioral therapy']}], 'interventions': [{'name': 'buprenorphine taper followed by naltrexone maintenance', 'type': 'DRUG', 'description': 'direct comparison of 1-, 2- and 4-week durations of buprenorphine taper for treating prescription opioid abusers; those who successfully taper without resumption of illicit opioid use are subsequently transitioned to oral naltrexone therapy for the remainder of the 12-week trial; all participants receive a platform of intensive individual behavioral therapy and on-site urinalysis monitoring throughout the trial', 'armGroupLabels': ['1-week buprenorphine taper', '2-week buprenorphine taper', '4-week buprenorphine taper']}, {'name': 'Behavioral therapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['1-week buprenorphine taper', '2-week buprenorphine taper', '4-week buprenorphine taper']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Substance Abuse Treatment Center, University of Vermont', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'overallOfficials': [{'name': 'Stacey C. Sigmon, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Vermont, Department of Psychiatry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vermont Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Stacey C. Sigmon, Ph.D.', 'oldOrganization': 'University of Vermont'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-09-10', 'type': 'RELEASE'}, {'date': '2014-09-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Stacey C. Sigmon, Dr. Stacey C. Sigmon, UVM Associate Professor of Psychiatry, University of Vermont Medical Center'}}}}