Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT02814305
Status:
COMPLETED
Last Update Posted:
2016-06-27
First Post:
2016-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Opioid Analgesic Use and Disposal Following Outpatient Dental Surgery
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'lastUpdateSubmitDate': '2016-06-22', 'studyFirstSubmitDate': '2016-06-16', 'studyFirstSubmitQcDate': '2016-06-22', 'lastUpdatePostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Unused opioids', 'timeFrame': '21 days after surgery', 'description': 'Number of opioids reported unused by the patient after postoperative day 21'}], 'secondaryOutcomes': [{'measure': 'Intent to dispose of opioids', 'timeFrame': 'Any time during the 21-day data collection period or during the follow-up interview on (or shortly after) postoperative day 21', 'description': 'Patient reports intent to dispose of leftover opioids during follow-up interview or by calling study hotline'}]}, 'conditionsModule': {'conditions': ['Opioid Use Disorders', 'Tooth Extraction Status Nos']}, 'descriptionModule': {'briefSummary': "Background: Overdose deaths from prescription opioid analgesics quadrupled from 4,000 cases to nearly 17,000 cases annually during 1999-2011. Most people who misuse or abuse prescription opioids obtain these pills from friends or family members who have surplus medication left over from prior prescriptions. There is little published data on surplus opioid analgesics remaining after patients recover from painful procedures. Even less is known about patients' willingness to dispose of these leftover pills.\n\nAims: 1) Measure the impact of a risk education intervention and a financial incentive intervention on patients' willingness to dispose of surplus opioids left over after outpatient dental surgery. 2) Measure the number and proportion of opioid pills left unused after outpatient dental surgery.\n\nMethods: The study will be a pilot randomized controlled trial. Adult patients at the Penn Dental Care Center will be enrolled prior to elective outpatient dental surgery. Patients will be randomized to a control group, an educational intervention, or a financial incentive intervention. The primary outcome of the trial is the proportion of patients in each arm that express willingness to return their unused opioids. Secondary outcomes include patient use of prescribed opioids and their number of unused pills. These outcomes will be measured using novel text-message based data collection software that patients will interact with using a web-enabled cellular telephone or tablet."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-institutionalized\n\nExclusion Criteria:\n\n* pregnancy\n* a history of opioid analgesic misuse/abuse\n* ongoing participation in other clinical research\n* or daily use of opioid analgesics in the week prior to surgery'}, 'identificationModule': {'nctId': 'NCT02814305', 'briefTitle': 'Opioid Analgesic Use and Disposal Following Outpatient Dental Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Opioid Analgesic Use and Disposal Following Outpatient Dental Surgery', 'orgStudyIdInfo': {'id': '821823'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patient receives neither educational nor financial interventions'}, {'type': 'EXPERIMENTAL', 'label': 'Financial intervention only', 'description': 'Patient receives financial (pharmacy offer) intervention only', 'interventionNames': ['Behavioral: Financial']}, {'type': 'EXPERIMENTAL', 'label': 'Educational intervention only', 'description': 'Patient receives educational (narrative) intervention only', 'interventionNames': ['Behavioral: Educational']}, {'type': 'EXPERIMENTAL', 'label': 'Both interventions', 'description': 'Patient receives both educational and financial interventions', 'interventionNames': ['Behavioral: Financial', 'Behavioral: Educational']}], 'interventions': [{'name': 'Financial', 'type': 'BEHAVIORAL', 'description': 'Patient receives information on a program that may offer a financial benefit for disposing of unused opioid analgesics at a pharmacy', 'armGroupLabels': ['Both interventions', 'Financial intervention only']}, {'name': 'Educational', 'type': 'BEHAVIORAL', 'description': 'Patient watches a video featuring narrative vignettes of patients who developed opioid dependence or abuse after using opioids postoperatively', 'armGroupLabels': ['Both interventions', 'Educational intervention only']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}