Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-05 @ 2:51 AM
Study NCT ID:
NCT03631251
Status:
COMPLETED
Last Update Posted:
2020-07-09
First Post:
2018-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Honest Placebos to Improve Pain Management in Hand Surgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-09-02', 'releaseDate': '2025-08-14'}], 'estimatedResultsFirstSubmitDate': '2025-08-14'}}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-07', 'studyFirstSubmitDate': '2018-07-26', 'studyFirstSubmitQcDate': '2018-08-13', 'lastUpdatePostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enrollment Percentage', 'timeFrame': 'Through study enrollment, 1 day', 'description': 'Percentage of Eligible Patients who Enroll'}, {'measure': 'Retention Rate', 'timeFrame': 'through study completion, approximately 2 months', 'description': 'Percentage of Patients who are Retained at follow-up'}, {'measure': 'Placebo Intake', 'timeFrame': '7 days', 'description': 'Number of Placebos Participants Take'}, {'measure': 'Placebo Analgesia', 'timeFrame': '7 days', 'description': 'Analgesia associated with placebo pills'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hand or Wrist Surgery']}, 'descriptionModule': {'briefSummary': 'America is in the midst of an opioid epidemic. One of the reasons opioid addiction and overdose deaths have recently increased is that doctors are frequently prescribing opioid medication as a treatment for pain. If it is possible to develop new ways of increasing the pain-relief patients experience from a set amount of opioids, then doctors might ultimately be able to prescribe fewer opioid medications, which could help curb the opioid crisis.\n\nAlthough "placebos," a medication whose benefit derives solely from positive psychological factors rather than pharmacological factors, are often disparaged in medicine, research suggests that placebos can actually help reduce pain. In fact, there is reason to think that placebos are effective even when a patient knows they are taking a placebo.\n\nThe goal of the proposed study is to examine the feasibility of using an honest placebo to relieve pain for up to 20 real patients. People who are undergoing hand or wrist surgery or enrolled for upper extremity trauma in the Emergency Department and agree to participate will be asked to take placebo pills in addition to their standard course of opioid pills, given as part of standard care. Patients will also answer a few short questions over the phone once per day for seven days, and be invited to participate in an exit questionnaire at the end of the study. The investigators hypothesize that: 1) At least 50% of eligible participants will agree to enroll, 2) At least 80% of participants who are enrolled will be retained, and 3) Participants who are enrolled will take a placebo at least 50% of the time they also take an opioid pill'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria, University Orthopedics \\& Department of Plastic \\& Reconstructive Surgery:\n\n* 18 years or older\n* English Speaking\n* Have a working phone\n* Scheduled for hand or wrist surgery\n* Able to provide informed consent Inclusion Criteria, Miriam Hospital Emergency Department\n* 18 years or older\n* English Speaking\n* Have a working phone\n* Able to provide informed consent\n* Present for upper extremity trauma\n* Are expected to be prescribed opioids at discharge\n* Are expected to be discharged from the Emergency Department\n\nExclusion Criteria, University Orthopedics \\& Department of Plastic \\& Reconstructive Surgery::\n\n* Known history of Substance Use Disorder\n* Chronic pain\n* Chronic opioid use\n* The prescribing physician deems opioid medication not appropriate as part of standard care for any reason Exclusion Criteria, Miriam Hospital Emergency Department\n* Known history of Substance Use Disorder\n* Chronic pain\n* Chronic opioid use\n* Unlikely to follow-up (discretion of investigator and treating provider)\n* Likely to receive surgical repair of the indicated injury'}, 'identificationModule': {'nctId': 'NCT03631251', 'briefTitle': 'Using Honest Placebos to Improve Pain Management in Hand Surgery Patients', 'organization': {'class': 'OTHER', 'fullName': 'Brown University'}, 'officialTitle': 'Enhancing Analgesia With Non-Deceptive Placebos: A Proof-Of-Concept Pilot Study', 'orgStudyIdInfo': {'id': 'IRB00000556'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open Placebo', 'description': 'Open placebo in addition to the standard course of opioids. Opioids are given consistent with standard care.', 'interventionNames': ['Drug: Open Placebo']}], 'interventions': [{'name': 'Open Placebo', 'type': 'DRUG', 'description': 'Open placebo in addition to the standard course of opioids. Opioids are given consistent with standard care.', 'armGroupLabels': ['Open Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02915', 'city': 'East Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'University Orthopedics', 'geoPoint': {'lat': 41.81371, 'lon': -71.37005}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Miriam Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rhode Island Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoctoral Fellow', 'investigatorFullName': 'Michael Bernstein', 'investigatorAffiliation': 'Brown University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-08-14', 'type': 'RELEASE'}, {'date': '2025-09-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Michael Bernstein, Postdoctoral Fellow, Brown University'}}}}