Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2026-02-28 @ 9:11 PM
Study NCT ID:
NCT03149718
Status:
COMPLETED
Last Update Posted:
2019-10-14
First Post:
2017-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community Pharmacists and Opioid Misuse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D055118', 'term': 'Medication Adherence'}], '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': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-11', 'studyFirstSubmitDate': '2017-05-05', 'studyFirstSubmitQcDate': '2017-05-09', 'lastUpdatePostDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intervention feasibility', 'timeFrame': 'Month 21 of Study', 'description': 'Intervention feasibility will be established through delivery of all BI-MTM components to 85% of BI-MTM recipients.'}, {'measure': 'Intervention acceptability', 'timeFrame': 'Month 21 of Study', 'description': 'Intervention acceptability will be demonstrated though qualitative interviews.'}], 'secondaryOutcomes': [{'measure': 'Opioid Misuse', 'timeFrame': 'Month 21 of Study', 'description': 'Opioid misuse will be demonstrated by the Prescription Opioid Misuse Index (POMI).'}, {'measure': 'Patient Self-Management', 'timeFrame': 'Month 21 of Study', 'description': 'Patient self-management activation misuse than will be captured by the Patient Activation Measure.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pharmacy', 'Intervention', 'Medication Adherence'], 'conditions': ['Opioid Misuse']}, 'descriptionModule': {'briefSummary': 'Opioid medication misuse and overdose have reached epidemic proportions in the US. Community pharmacy is a potentially valuable resource for addressing opioid medication misuse. This study will manualize and establish the feasibility, acceptability, and clinical effect of a community pharmacist-led intervention aimed at: improving opioid mediation regimen adherence, eliminating misuse, connecting patients to additional care, and safeguarding against overdose.', 'detailedDescription': 'The current small scale single-blinded randomized controlled study will build on our preliminary studies by manualizing and examining the feasibility, acceptability, and clinical effect for the Brief Intervention Medication Therapy Management (BI-MTM) model. BI-MTM is a multicomponent community pharmacy-based intervention. BI-MTM is designed to: (1) promote opioid medication regimen adherence, (2) reduce opioid medication misuse, (3) connect participants with patient navigation (a chronic condition care model) to increase self-management of health conditions that increase risk for misuse, and (4) provide naloxone rescue training referrals. Patients will be screened across 14 months for opioid medication misuse in an urban community pharmacy affiliated with a major medical system. Patients positive for misuse will be randomly assigned to BI-MTM (n=23) or Standard Medication Counseling (n=23). Standard Medication Counseling is the Centers for Medicaid and Medicare Services requirement for pharmacists in the US wherein pharmacy patients filling prescriptions receive information and opt-in counseling. This study will demonstrate feasibility and acceptability of BI-MTM for community pharmacy patients who misuse their opioid medications for future intervention implementation in a fully powered randomized trial. This study will also generate preliminary data regarding opioid medication misuse elimination and increases in participant self-management activation for comorbid health conditions that increase risk for misuse.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Opioid Misuse\n\n -≥18 years\n* English speaking\n\nExclusion Criteria:\n\n* Are pregnant (given potential pre/post-natal opioid use complications among pregnant women/offspring)\n* Cannot provide collateral contact information for ≥2 contact persons (to ensure consistent contact/follow up)\n* Do not have a reliable landline or mobile phone to be contacted by study staff\n* Are only filling buprenorphine (given some formulations are not indicated for pain)\n* Plan to leave the area for an extended period of time in the next 3 months\n* Have had a psychotic and/or manic episode in the last 30 days'}, 'identificationModule': {'nctId': 'NCT03149718', 'briefTitle': 'Community Pharmacists and Opioid Misuse', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Prescription Opioid Misuse: Pharmacist-Delivered Intervention at Point of Service', 'orgStudyIdInfo': {'id': 'PRO17010410'}, 'secondaryIdInfos': [{'id': 'R21DA043735', 'link': 'https://reporter.nih.gov/quickSearch/R21DA043735', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SMC (n=23)', 'description': 'Standard Medication Counseling.', 'interventionNames': ['Behavioral: Standard Medication Counseling (SMC)']}, {'type': 'EXPERIMENTAL', 'label': 'BI-MTM (n=23)', 'description': 'Brief Intervention Medication Therapy Management.', 'interventionNames': ['Behavioral: Brief Intervention Medication Therapy Management']}], 'interventions': [{'name': 'Brief Intervention Medication Therapy Management', 'type': 'BEHAVIORAL', 'description': 'BI-MTM is designed to: (1) eliminate opioid medication misuse, (2) promote opioid regimen adherence, (3) connect participants with Patient Navigation to increase patient self-management activation for health conditions that increase risk for misuse (Patient Navigation is an evidence-based chronic care intervention), and (4) provide naloxone rescue training referrals.', 'armGroupLabels': ['BI-MTM (n=23)']}, {'name': 'Standard Medication Counseling (SMC)', 'type': 'BEHAVIORAL', 'description': 'Standard Medication Counseling (SMC; n=23; i.e., treatment-as-usual condition). Standard Medication Counseling is the Centers for Medicaid and Medicare Services requirement for pharmacists in the US wherein pharmacy patients filling prescriptions receive information and opt-in counseling.', 'armGroupLabels': ['SMC (n=23)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Falk Pharmacy', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15501', 'city': 'Somerset', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Medicine Shoppe', 'geoPoint': {'lat': 40.00841, 'lon': -79.07808}}], 'overallOfficials': [{'name': 'Gerald Cochran, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jerry Cochran', 'investigatorAffiliation': 'University of Utah'}}}}