Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:23 PM
Study NCT ID:
NCT05307458
Status:
UNKNOWN
Last Update Posted:
2023-05-26
First Post:
2022-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating the Pharmacokinetics and Patient Outcomes of Buprenorphine Microdosing
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-24', 'studyFirstSubmitDate': '2022-03-17', 'studyFirstSubmitQcDate': '2022-03-31', 'lastUpdatePostDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid withdrawal symptoms', 'timeFrame': '14-days', 'description': 'Opioid withdrawal symptoms will be measured using the clinical opiate withdrawal scale (COWS) score and subjective opiate withdrawal scale (SOWS) score.'}], 'secondaryOutcomes': [{'measure': 'Acute Precipitated Withdrawal', 'timeFrame': '14-days', 'description': 'Severe opioid withdrawal symptoms resulting in hospitalization.'}, {'measure': 'Treatment retention', 'timeFrame': '6-months', 'description': 'Patient retention in the buprenorphine treatment program. Defined as continued treatment with buprenorphine.'}, {'measure': 'Area Under the Curve', 'timeFrame': '14-days', 'description': 'Buprenorphine AUC will be measured in participants.'}, {'measure': 'Peak concentration', 'timeFrame': '14-days', 'description': 'Buprenorphine peak concentrations will be measured in participants.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Use Disorder', 'Opioid Withdrawal']}, 'descriptionModule': {'briefSummary': 'There are more than 2.1 million people in the United States with opioid use disorder, and according to preliminary data from the US Centers for Disease Control and Prevention opioid overdose deaths rose 36% to more than 69,000 deaths in 2020. Treatment with buprenorphine or methadone reduces overdose deaths in patients with opioid use disorder. However, most patients with opioid use disorder do not receive treatment. In addition to the rising rates of morbidity and mortality, the healthcare, social, and societal costs of the opioid epidemic are roughly one trillion dollars annually. Rapidly scalable strategies are needed to increase access to treatment and improve treatment retention.\n\nThe investigators propose a novel buprenorphine micro-dosing study to evaluate the pharmacokinetics, treatment retention, and qualitative outcomes in participants transitioning from methadone maintenance therapy to buprenorphine using a micro-dosing initiation in the outpatient setting. The proposed study will report participant pharmacokinetics, treatment retention, Clinical Opiate Withdrawal Scale (COWS) score, Treatment Satisfaction Questionnaire for Medication (TSQM) score, and other qualitative outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will include adults (at least 18 years of age) who have been enrolled and receiving consistent treatment in the methadone program for at least 6 months. Participants will be excluded if they are on a methadone dose \\> 80 mg, have concurrent alcohol use or benzodiazepine use disorder, require opioids for a pain-related diagnosis, are a current suicide or homicide risk, have a current psychotic disorder (DSM-V) or untreated major depression, have a life-threatening or unstable medical problem, or are pregnant.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants will include adults (at least 18 years of age) who have been enrolled and receiving consistent treatment in the methadone program for at least 6 months.\n\nExclusion Criteria:\n\n* Participants will be excluded if they are on a methadone dose \\> 80 mg, have concurrent alcohol use or benzodiazepine use disorder, require opioids for a pain-related diagnosis, are a current suicide or homicide risk, have a current psychotic disorder (DSM-V) or untreated major depression, have a life-threatening or unstable medical problem, or are pregnant.'}, 'identificationModule': {'nctId': 'NCT05307458', 'briefTitle': 'Evaluating the Pharmacokinetics and Patient Outcomes of Buprenorphine Microdosing', 'organization': {'class': 'OTHER', 'fullName': 'United Health Services Hospitals, Inc.'}, 'officialTitle': 'Evaluating the Pharmacokinetics and Patient Outcomes of Buprenorphine Microdosing', 'orgStudyIdInfo': {'id': '11453'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Buprenorphine Microdosing', 'description': 'Participants transitioning to buprenorphine from methadone using a microdosing protocol.', 'interventionNames': ['Drug: Buprenorphine/naloxone']}], 'interventions': [{'name': 'Buprenorphine/naloxone', 'type': 'DRUG', 'description': 'Participants will receive gradually increasing doses of buprenorphine while tapering down on their methadone dose.', 'armGroupLabels': ['Buprenorphine Microdosing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13903', 'city': 'Binghamton', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Terri K Peters, RN MSN CCRP', 'role': 'CONTACT', 'email': 'terri.peters@nyuhs.org', 'phone': '607-763-5697'}, {'name': 'Kathy A Hughes, RN MS', 'role': 'CONTACT', 'email': 'kathy.hughes@nyuhs.org', 'phone': '607-763-5368'}], 'facility': 'UHS Addiction Medicine', 'geoPoint': {'lat': 42.09869, 'lon': -75.91797}}], 'centralContacts': [{'name': 'William Eggleston, PharmD', 'role': 'CONTACT', 'email': 'wegglest@binghamton.edu', 'phone': '607-777-5848'}, {'name': 'Terri K Peters, RN MSN CCRP', 'role': 'CONTACT', 'email': 'terri.peters@nyuhs.org', 'phone': '6077635697'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United Health Services Hospitals, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Binghamton University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'William Eggleston', 'investigatorAffiliation': 'Binghamton University'}}}}