Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-03 @ 9:02 PM
Study NCT ID:
NCT02712034
Status:
COMPLETED
Last Update Posted:
2020-04-14
First Post:
2016-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact on Opioid Use of Bundling Medication-assisted Treatment With mHealth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 417}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-10', 'studyFirstSubmitDate': '2016-03-14', 'studyFirstSubmitQcDate': '2016-03-16', 'lastUpdatePostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid use', 'timeFrame': '24 months', 'description': 'Detect the difference in illicit opioid use between patients who have MAT + A-CHESS vs. MAT alone.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Medication-assisted treatment (MAT)', 'Buprenorphine', 'Methadone', 'Naltrexone'], 'conditions': ['Opioid Use Disorder']}, 'referencesModule': {'references': [{'pmid': '33616545', 'type': 'DERIVED', 'citation': 'Hochstatter KR, Gustafson DH Sr, Landucci G, Pe-Romashko K, Cody O, Maus A, Shah DV, Westergaard RP. Effect of an mHealth Intervention on Hepatitis C Testing Uptake Among People With Opioid Use Disorder: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Feb 22;9(2):e23080. doi: 10.2196/23080.'}, {'pmid': '31373273', 'type': 'DERIVED', 'citation': 'Hochstatter KR, Gustafson DH Sr, Landucci G, Pe-Romashko K, Maus A, Shah DV, Taylor QA, Gill EK, Miller R, Krechel S, Westergaard RP. A Mobile Health Intervention to Improve Hepatitis C Outcomes Among People With Opioid Use Disorder: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Aug 1;8(8):e12620. doi: 10.2196/12620.'}, {'pmid': '27955689', 'type': 'DERIVED', 'citation': 'Gustafson DH Sr, Landucci G, McTavish F, Kornfield R, Johnson RA, Mares ML, Westergaard RP, Quanbeck A, Alagoz E, Pe-Romashko K, Thomas C, Shah D. The effect of bundling medication-assisted treatment for opioid addiction with mHealth: study protocol for a randomized clinical trial. Trials. 2016 Dec 12;17(1):592. doi: 10.1186/s13063-016-1726-1.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to measure and explain the impact on long-term opioid use when medication-assisted treatment (MAT) is bundled with an evidence-based mobile-health system (A-CHESS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. are 18+ years old;\n2. meet criteria for opioid use disorders of at least moderate severity (4 or 5 DSM-V criteria);\n3. Are currently taking medication-assisted treatment (MAT) as part of their standard clinical care;\n4. have no acute medical problem requiring immediate inpatient treatment;\n5. have no history of psychotic disorders, though those with other co-morbid psychopathology (mood disorders, anxiety, other substance use disorders) will be eligible;\n6. are willing to participate in a randomized clinical trial;\n7. provide the name, verified telephone number, and address of at least 2 contacts willing to help locate the patient, if necessary, during follow-up;\n8. are able to read and write in English;\n9. are not pregnant;\n10. are willing to share health-related data with primary care clinicians; and\n11. are, at study intake, abstinent from opioids for at least 1 week and no longer than 2 months, except for medications used to treat the disorder (e.g., methadone).'}, 'identificationModule': {'nctId': 'NCT02712034', 'acronym': 'Bundling', 'briefTitle': 'Impact on Opioid Use of Bundling Medication-assisted Treatment With mHealth', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Impact on Opioid Use of Bundling Medication-assisted Treatment With mHealth', 'orgStudyIdInfo': {'id': '2015-1418'}, 'secondaryIdInfos': [{'id': '1R01DA040449-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA040449-01', 'type': 'NIH'}, {'id': 'A195010', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'INDUSTRIAL ENGR\\CHESS PROG', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Medication-assisted treatment (MAT)', 'description': 'Patients will receive standard medication-assisted treatment (MAT) as prescribed by their health care provider.', 'interventionNames': ['Other: MAT']}, {'type': 'EXPERIMENTAL', 'label': 'MAT + A-CHESS', 'description': 'Patients in the MAT + A-CHESS arm will receive MAT as described plus the A-CHESS recovery support system via a smartphone.', 'interventionNames': ['Behavioral: MAT + A-CHESS']}], 'interventions': [{'name': 'MAT + A-CHESS', 'type': 'BEHAVIORAL', 'description': 'Subjects randomized to MAT + A-CHESS will receive MAT plus the A-CHESS recovery support system which provides:\n\n1. Self-directed, interactive modules that teach basic recovery support, harm-reduction, and psychosocial functioning skills.\n2. The latest information about addiction and recovery support, monitoring prompts, and peer and family support.\n3. Advice on where to go for help and on how to make the best use of health and human services; and\n4. A way to talk with experts in the area of addiction and other study participants by sending anonymous messages in the A-CHESS discussion groups.\n5. A way to keep your health care team up to date through reports based on information entered into A-CHESS (i.e. alcohol and drug use, depression, MAT side effects).', 'armGroupLabels': ['MAT + A-CHESS']}, {'name': 'MAT', 'type': 'OTHER', 'description': 'Patients will receive treatment consisting of a recovery plan, appropriate pharmacology, routine urine screens, and regularly scheduled behavioral interventions, such as monthly group counseling sessions or sessions with a recovery coach. "Appropriate pharmacology" may include methadone; naltrexone; buprenorphine; and in the case of overdose, naloxone; and other medications and combinations of medications as part of the patient\'s standard clinical care.', 'armGroupLabels': ['Medication-assisted treatment (MAT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53713', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Access Community Health Centers', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'David H Gustafson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UW Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stanley Street Treatment and Resources (SSTAR)', 'class': 'UNKNOWN'}, {'name': 'Gosnold on Cape Cod', 'class': 'UNKNOWN'}, {'name': 'ARC Community Services, Inc.', 'class': 'UNKNOWN'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}