Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT04768920
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-10
First Post:
2021-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Examining Feasibility and Acceptability of Telemedicine for Substance Use Disorder (SUD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-06', 'studyFirstSubmitDate': '2021-02-19', 'studyFirstSubmitQcDate': '2021-02-19', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in frequency of substance use as reported on the Timeline Follow-Back (TLFB)', 'timeFrame': 'baseline, 8 weeks post-baseline', 'description': 'Based on frequency and quantity, higher scores indicate worse outcome.'}, {'measure': 'Change in Alcohol Consumption', 'timeFrame': 'baseline, 8 weeks post baseline', 'description': 'Alcohol consumption will be assessed using the 30-day Timeline Follow-Back (TLFB). The TLFB will capture information on the frequency and quantity of alcohol use including binge drinking, with total consumption calculated.'}], 'primaryOutcomes': [{'measure': 'Feasibility of the intervention (engagement)', 'timeFrame': '8 weeks', 'description': 'Percent (%) of participants engaging in the intervention'}, {'measure': 'Tele-Tx Intervention acceptability', 'timeFrame': '8 weeks', 'description': 'Study-specific acceptability rating completed by participants. Based on Likert scale, higher scores indicate greater treatment acceptability'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Telehealth', 'Motivational interviewing', 'Cognitive behavioral therapy'], 'conditions': ['Substance Use Disorders', 'Substance Use', 'Substance Dependence']}, 'descriptionModule': {'briefSummary': 'The objective of this pilot intervention study is to iteratively refine motivational interviewing and psychosocial intervention programs delivered via telehealth (Teletx) to help improve substance use and other related outcomes in SUD patients who are not receiving SUD care. We will examine feasibility and acceptability of these pilot psychosocial programs in a total of n=50 participants. The goal is to refine the programs to improve acceptability and feasibility and collect preliminary data for a future fully powered randomized controlled trial (RCT) in the future.\n\nIn addition to study sessions, participants that are enrolled in the study will complete surveys prior to, during, and after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatient care at Michigan Medicine in past year\n* Diagnostic and Statistical Manual of Mental Disorders (DSM-5) SUD diagnosis and/or substance use on average of 2 days a week over the past month\n* Have a Smart phone, tablet or another Wi-Fi or data-enabled device (e.g. with a camera)\n\nExclusion Criteria:\n\n* Inability to speak or understand English\n* Conditions that preclude informed consent (e.g., acute psychosis, cognitive deficits) or understanding of assessment or program content\n* Prior alcohol withdrawal seizures or delirium tremens (DTs). Those who are at-risk of complicated withdrawal (e.g., seizures, DTs) require greater medical attention and will be excluded and referred to their clinician for medical management.'}, 'identificationModule': {'nctId': 'NCT04768920', 'briefTitle': 'Examining Feasibility and Acceptability of Telemedicine for Substance Use Disorder (SUD)', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Examining Feasibility and Acceptability of Telemedicine for Substance Use Disorder (SUD)', 'orgStudyIdInfo': {'id': 'HUM00189259'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Teletx', 'description': 'The evidence-based manualized psychosocial programs that will be delivered via telehealth are adaptations of cognitive behavioral therapy, motivational interviewing, and other psychosocial interventions to enhance initial and ongoing treatment engagement. TeleTx consists of up to 8 \\~30-50 minute psychosocial sessions delivered via phone or videoconference platform (e.g. Zoom etc).', 'interventionNames': ['Behavioral: MI-CBT Teletx']}], 'interventions': [{'name': 'MI-CBT Teletx', 'type': 'BEHAVIORAL', 'description': 'Participants will first receive a 20-45 min phone or video session focused on raising participants\' motivation to engage in treatment activities and psychoeducation material about substance use (i.e. "engagement session") including possible discussion about risks of substance use, value of alternative healthier activities, and the community and crisis resources pamphlet. The evidence-based manualized psychosocial programs that will be delivered via telehealth are adaptations of cognitive behavioral therapy, motivational interviewing, and other psychosocial interventions to enhance initial and ongoing treatment engagement. TeleTx consists of up to 8 \\~30-50 minute psychosocial sessions delivered via phone or videoconference platform (e.g. Zoom etc)', 'armGroupLabels': ['Teletx']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Allison Lin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Psychiatry', 'investigatorFullName': 'Allison Lin', 'investigatorAffiliation': 'University of Michigan'}}}}