Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT06458335
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2024-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intervening on Opioid Use and Loneliness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D012934', 'term': 'Social Isolation'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2024-06-09', 'studyFirstSubmitQcDate': '2024-06-09', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change in loneliness', 'timeFrame': 'Baseline to 6 months', 'description': "Loneliness will be measured using the UCLA Loneliness Scale. A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item as 1 (never), 2 (rarely), 3 (sometimes) or 4 (often). The scores range from 20-80 with higher scores indicating worse outcome."}, {'measure': 'Mean change in number of days of opioid use', 'timeFrame': 'Baseline to 6 months', 'description': 'Participants will complete a calendar indicating the type and frequency of drug use.'}], 'secondaryOutcomes': [{'measure': 'mean change in social interactions', 'timeFrame': 'Baseline to 6 months', 'description': 'Duke Social Support Index assesses several domains of perceived social support, including social network size, social interaction, social satisfaction, and instrumental social support. Higher scores indicate a higher quality of social interactions. Scores range from 0 to 37.'}, {'measure': 'Mean change in depression', 'timeFrame': 'Baseline to 6 months', 'description': 'Depression will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.'}, {'measure': 'Mean change in anxiety', 'timeFrame': 'Baseline to 6 months', 'description': 'Anxiety will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Use Disorder', 'Loneliness', 'Social Isolation']}, 'descriptionModule': {'briefSummary': 'This study aims to enroll 300 participants who will be assigned to one of three 3 groups. Each group will receive an intervention lasting 6, weekly sessions of 40-60 minutes. Eligibility include having an opioid use disorder and reporting loneliness or feeling alone or disconnected.', 'detailedDescription': 'Individuals (n = 300) with an opioid use disorder reporting loneliness will be randomized to either (1) therapist-delivered cognitive-behavioral therapy for perceived social isolation, (2) therapist-delivered Health Education, or (3) self-guided Health Education. Loneliness, opioid and other substance use, the amount of social interactions, social support, and mental and physical health factors prior to starting the treatment, after completing the treatment, and 1, 3, and 6 months following the treatment will be assessed to see how well they work compared to each other.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be 18+\n* understand English -have internet access-\n* screen positive for an opioid use disorder\n* screen positive for elevated loneliness\n\nExclusion Criteria:\n\n* does not understand consent\n* does not have consistent access to a phone and internet'}, 'identificationModule': {'nctId': 'NCT06458335', 'briefTitle': 'Intervening on Opioid Use and Loneliness', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Addressing Loneliness as a Therapy Target Among Individuals Using Opioids', 'orgStudyIdInfo': {'id': 'STUDY00009396'}, 'secondaryIdInfos': [{'id': '1R01DA060966', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA060966', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive-Behavioral Therapy', 'description': 'CBT delivered over the course of 6, \\~45 minute sessions delivered via telehealth', 'interventionNames': ['Behavioral: Cognitive-Behavioral Therapy for Perceived Social Isolation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'therapist-delivered Health Education', 'description': 'Health education sessions delivered over the course of 6, \\~45 minute sessions delivered via telehealth.', 'interventionNames': ['Behavioral: Health Education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'self-guided Health Education', 'description': 'Health education sessions that are self-guided over the course of 6 sessions', 'interventionNames': ['Behavioral: Health Education']}], 'interventions': [{'name': 'Cognitive-Behavioral Therapy for Perceived Social Isolation', 'type': 'BEHAVIORAL', 'otherNames': ['CBT-PSI'], 'description': '6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use', 'armGroupLabels': ['Cognitive-Behavioral Therapy']}, {'name': 'Health Education', 'type': 'BEHAVIORAL', 'description': 'Health education provides information on the importance and benefits of and guidelines for living a health lifestyle', 'armGroupLabels': ['self-guided Health Education', 'therapist-delivered Health Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lisham Ashrafioun, PhD', 'role': 'CONTACT', 'phone': '585-430-2026'}], 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'centralContacts': [{'name': 'Lisham Ashrafioun, PhD', 'role': 'CONTACT', 'email': 'lisham_ashrafioun@urmc.rochester.edu', 'phone': '585-430-2026'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'De-identified participant data is available upon request through a data use agreement as part of scientific collaboration'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, {'name': 'Ohio State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Lisham Ashrafioun', 'investigatorAffiliation': 'University of Rochester'}}}}