Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT03580902
Status:
COMPLETED
Last Update Posted:
2023-01-04
First Post:
2018-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CBT4CBT for Office Based Buprenorphine
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069479', 'term': 'Buprenorphine, Naloxone Drug Combination'}], 'ancestors': [{'id': 'D002047', 'term': 'Buprenorphine'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-02', 'studyFirstSubmitDate': '2018-06-25', 'studyFirstSubmitQcDate': '2018-07-06', 'lastUpdatePostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of urine toxicology screens that are negative for opioids by group.', 'timeFrame': '12 weeks', 'description': 'Percent of urine toxicology screens, collected weekly, that are negative for opioid metabolites.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid-use Disorder']}, 'descriptionModule': {'briefSummary': 'In this Phase II SBIR/STTR project, our Specific Aim will be to determine if the use of CBT4CBT-Buprenorphine leads to clinically significant improved outcomes and increased retention for buprenorphine maintenance patients in a larger and diverse population of individuals seeking buprenorphine treatment in primary care (N=100).', 'detailedDescription': 'In this phase, 100 individuals entering buprenorphine maintenance at the primary care clinic (Central Medical Unit, CMU) will be randomized to either (1) standard buprenorphine maintenance in which counseling is offered on site, or (2) standard buprenorphine maintenance with CBT4CBT-Buprenorphine substituting for on-site counseling. This will be a 12-week trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meets current Diagnostic Statistical Manual (DSM-5) criteria for opioid use disorder\n* Requesting buprenorphine maintenance treatment at Central Medical Unit of the APT Foundation\n\nExclusion Criteria:\n\n* Unstabilized psychotic disorder\n* Currently suicidal or homicidal\n* Current cocaine, benzodiazepine, or alcohol use disorder.\n* Any history of PCP (phencyclidine) use.\n* Pregnant or lactating\n* Any other physical or mental condition that would contraindicate office-based buprenorphine maintenance treatment.'}, 'identificationModule': {'nctId': 'NCT03580902', 'briefTitle': 'CBT4CBT for Office Based Buprenorphine', 'organization': {'class': 'INDUSTRY', 'fullName': 'CBT4CBT, LLC'}, 'officialTitle': 'A Method to Increase Buprenorphine Treatment Capacity', 'orgStudyIdInfo': {'id': '41941'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Buprenorphine', 'description': 'Participants assigned to this arm will received buprenorphine treatment consistent with standard practice at the study site. This includes induction by a physician, regular meetings with a physician for medical management, urine monitoring, and prescription of buprenorphine, with access to behavioral support services.', 'interventionNames': ['Drug: Buprenorphine/naloxone']}, {'type': 'EXPERIMENTAL', 'label': 'Standard Buprenorphine plus CBT4CBT-Buprenorphine', 'description': 'Participants in this condition will receive Standard Buprenorphine as described above, with the addition of access to the CBT4CBT-Buprenorphine program, which is a web-based program that covers basic knowledge about buprenorphine treatment as well as teaches cognitive and behavioral coping skills.', 'interventionNames': ['Behavioral: CBT4CBT-Buprenorphine', 'Drug: Buprenorphine/naloxone']}], 'interventions': [{'name': 'CBT4CBT-Buprenorphine', 'type': 'BEHAVIORAL', 'description': 'Computerized, user-driven cognitive-behavioral therapy (CBT) web-based program adapted for use in office based buprenorphine treatment', 'armGroupLabels': ['Standard Buprenorphine plus CBT4CBT-Buprenorphine']}, {'name': 'Buprenorphine/naloxone', 'type': 'DRUG', 'description': 'Standard outpatient buprenorphine maintenance', 'armGroupLabels': ['Standard Buprenorphine', 'Standard Buprenorphine plus CBT4CBT-Buprenorphine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511-5991', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Central Medical Unit of the APT Foundation', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Julia Shi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APT Foundation, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CBT4CBT, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}