Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2026-01-01 @ 10:38 AM
Study NCT ID:
NCT04239235
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-16
First Post:
2020-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrating Support Persons Into Recovery
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': 'NONE', 'maskingDescription': 'Participants will be told which condition they are in.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-arm RCT where participants are randomly assigned to intervention or control.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 422}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2020-01-06', 'studyFirstSubmitQcDate': '2020-01-22', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient buprenorphine retention', 'timeFrame': '6 months after baseline', 'description': 'Percentage of patients who initiated OBOT who have at least 6 months of continuous treatment with buprenorphine with no more than a 7-day lapse between prescriptions'}, {'measure': 'Patient buprenorphine retention', 'timeFrame': '12 months after baseline', 'description': 'Percentage of patients who initiated OBOT who have at least 12 months of continuous treatment with buprenorphine with no more than a 7-day lapse between prescriptions'}], 'secondaryOutcomes': [{'measure': 'Patient opioid and other substance use', 'timeFrame': '3 and 12 months after baseline', 'description': 'Days of past month use'}, {'measure': 'Patient opioid and other substance use', 'timeFrame': '3 months after baseline', 'description': 'Days of past month use'}, {'measure': 'Patient and Support Person depression symptoms', 'timeFrame': '3 months after baseline', 'description': 'severity of depression (PHQ-9, Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression)'}, {'measure': 'Patient and Support Person depression symptoms', 'timeFrame': '12 months after baseline', 'description': 'severity of depression (PHQ-9, Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression)'}, {'measure': 'Patient and Support Person anxiety symptoms', 'timeFrame': '3 months after baseline', 'description': 'severity of anxiety (GAD-7, Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, and severe anxiety)'}, {'measure': 'Patient and Support Person anxiety symptoms', 'timeFrame': '12 months after baseline', 'description': 'severity of anxiety (GAD-7, Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, and severe anxiety)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Opioid Medication Assisted Treatment', 'Community Reinforcement Approach and Family Training'], 'conditions': ['Opioid Addiction']}, 'referencesModule': {'references': [{'pmid': '32653029', 'type': 'DERIVED', 'citation': 'Osilla KC, Becker K, Ecola L, Hurley B, Manuel JK, Ober A, Paddock SM, Watkins KE. Study design to evaluate a group-based therapy for support persons of adults on buprenorphine/naloxone. Addict Sci Clin Pract. 2020 Jul 11;15(1):25. doi: 10.1186/s13722-020-00199-2.'}]}, 'descriptionModule': {'briefSummary': "INtegrated Support Persons Into Recovery (INSPIRE) is a 4-year research project that tests whether integrating a patient's support person into a patient's treatment with Buprenorphine/Naloxone can improve outcomes. The study will examine whether a counseling program called CRAFT for a support person, such as a family member, spouse or friend, can improve patient outcomes.", 'detailedDescription': "Opioid use disorders (OUDs) have reached an all-time high and have devastating effects on the individual, family, and community. While medication treatment for OUD saves lives, rates of treatment drop out are very high. In addition, existing OUD treatments neglect the impact of untreated OUD on the family, and ignore the potential role family members and support persons (SPs) could have on encouraging long-term recovery. Incorporating the patient's support system may be an important way to improve treatment retention. The proposed study evaluates a counseling program for concerned family members, spouses, and friends called Community Reinforcement and Family Training (CRAFT), which is successful at engaging and retaining patients in substance use treatment. While promising, no studies have evaluated whether CRAFT can help patients remain on medication treatment for OUD, provided by community health clinics. If effective, this could save lives and help both patient and family member health outcomes. Patient and SP pairs will be recruited from community health clinics throughout northern and southern California. Patients taking OUD medication treatment will be recruited and randomly assign half of the SPs to receive CRAFT; the other half would receive treatment-as-usual. Patients and SPs will be interviewed three and twelve months later to evaluate whether patients with CRAFT SPs stay in OUD treatment longer, and whether patient and SP health outcomes improve."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Patient inclusion criteria:\n\n* 18 and older\n* on buprenorphine treatment for OUD\n* has an eligible support person that participates\n\nSupport person inclusion criteria:\n\n* 18 and older\n* frequent contact with the patient\n* willing and available to try CRAFT\n\nPatient exclusion criteria:\n\n* \\< 18 years and older\n* not currently receiving buprenorphine\n* not able to provide consent\n\nSupport person exclusion criteria:\n\n* \\< 18 years and older\n* currently has a problem with heroin or opioid pills\n* not able to provide consent\n* actively using other substances such that their presence in group would be contraindicated'}, 'identificationModule': {'nctId': 'NCT04239235', 'acronym': 'INSPIRE', 'briefTitle': 'Integrating Support Persons Into Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Comparative Effectiveness of Significant Other-Enhanced OBOT in Primary Care', 'orgStudyIdInfo': {'id': 'IRB-62016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Community Reinforcement Approach and Family Training is a 10-session rolling group for the support person.', 'interventionNames': ['Behavioral: CRAFT']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'This condition is for support persons who do not receive CRAFT. They will receive no intervention or usual care services available at the clinic.'}], 'interventions': [{'name': 'CRAFT', 'type': 'BEHAVIORAL', 'description': 'CRAFT is an evidence-based and non-confrontational approach for teaching friends/family members strategies to help their loved one reduce/refrain from using substances. It focuses on improving the lives of both the friends/family members and the individual struggling with substance use.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95521', 'city': 'Arcata', 'state': 'California', 'country': 'United States', 'facility': 'Open Door Community Health Centers', 'geoPoint': {'lat': 40.86652, 'lon': -124.08284}}, {'zip': '94703', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Lifelong Medical Care', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '94553', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'Contra Costa Health Services', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '90249', 'city': 'Gardena', 'state': 'California', 'country': 'United States', 'facility': 'Behavioral Health Services', 'geoPoint': {'lat': 33.88835, 'lon': -118.30896}}, {'zip': '92110', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Family Health Centers of San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90291', 'city': 'Venice', 'state': 'California', 'country': 'United States', 'facility': 'Venice Family Clinic', 'geoPoint': {'lat': 33.99084, 'lon': -118.46008}}], 'overallOfficials': [{'name': 'Karen Osilla, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Karen Osilla', 'investigatorAffiliation': 'Stanford University'}}}}