Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2026-01-04 @ 6:25 AM
Study NCT ID:
NCT03077932
Status:
COMPLETED
Last Update Posted:
2020-08-13
First Post:
2017-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An App to Aid in Transitioning Off Opioid Medication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-12', 'studyFirstSubmitDate': '2017-03-08', 'studyFirstSubmitQcDate': '2017-03-10', 'lastUpdatePostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opiate use', 'timeFrame': '1 month post-taper', 'description': 'Days of opiate use at follow-up'}], 'secondaryOutcomes': [{'measure': 'Fear of withdrawal symptoms', 'timeFrame': '1 month post-taper', 'description': 'Fear of withdrawal symptoms'}, {'measure': 'Opiate Withdrawal', 'timeFrame': 'Baseline to 1 month post-taper', 'description': 'opiate withdrawal symptoms'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opiate Use Disorder', 'Opiate Withdrawal Syndrome']}, 'descriptionModule': {'briefSummary': 'The investigators propose to develop a smartphone app (called BetterOFF) that will help patients manage opioid withdrawal during opioid medication taper and detoxification. The BetterOFF smartphone intervention will be a resource patients can access anytime and anywhere. If the BetterOFF intervention were to be effective in helping patients discontinue opioid medication, it could be integrated into the standard of care of office-based clinical practices, as well as substance use programs, thereby having a substantial public health impact.', 'detailedDescription': 'Many of the growing number of patients prescribed long-term opioid medication (for a variety of reasons including a history of illicit opioid use or management of chronic pain) will express an interest in discontinuing medication. However, many patients, physically dependent on opioids, fear the withdrawal symptoms that inevitably occur with opioid medication discontinuation and will experience a decrease in their self-efficacy for abstinence at the end of a taper. As a result, tapering is often slow and done hesitantly, and relapse rates after an opioid taper are high and associated with broad consequences, including significant negative physical, mental, and social problems. Even with optimal tapering protocols, patients need novel approaches to manage the discontinuation of opiate agonist treatment. Given this important gap in opioid treatment delivery, we propose to develop a theoretically-driven, smartphone-delivered intervention (Better Off app) to help patients effectively manage the experience of opioid medication discontinuation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between 18-65 years of age;\n* currently receiving opioid medication;\n* interesting in discontinuing opioid medication\n* has a smartphone\n\nExclusion Criteria:\n\n* non-English speaking.'}, 'identificationModule': {'nctId': 'NCT03077932', 'acronym': 'BetterOFF', 'briefTitle': 'An App to Aid in Transitioning Off Opioid Medication', 'organization': {'class': 'OTHER', 'fullName': 'Butler Hospital'}, 'officialTitle': 'A Smartphone App to Facilitate Buprenorphine Discontinuation', 'orgStudyIdInfo': {'id': '840059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'App Development and Open Pilot', 'description': 'Phase 1 (app development) will consist of: 1) development of the BetterOFF prototype; and 2) series of usability studies with patients interested in discontinuing opioid medication.\n\nPhase 2 (open pilot) will involve conducting a 12-week open pilot trial (n=20) to test the feasibility and acceptability of the BetterOFF app with patients tapering from opiate medication.', 'interventionNames': ['Other: App Development and Open Pilot']}], 'interventions': [{'name': 'App Development and Open Pilot', 'type': 'OTHER', 'description': 'Phase 1 (app development) will consist of: 1) development of the BetterOFF prototype; and 2) series of usability studies with patients interested in discontinuing opioid medication.\n\nPhase 2 (open pilot) will involve conducting a 12-week open pilot trial (n=20) to test the feasibility and acceptability of the BetterOFF app with patients tapering from opiate medication.', 'armGroupLabels': ['App Development and Open Pilot']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Butler Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Ana Abrantes, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Butler Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Butler Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}