Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-08 @ 7:06 AM
Study NCT ID:
NCT05952960
Status:
COMPLETED
Last Update Posted:
2025-07-28
First Post:
2023-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Open Label Placebo Rationales
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2023-05-01', 'studyFirstSubmitQcDate': '2023-07-17', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Reports', 'timeFrame': '21 days', 'description': 'Brief Pain Inventory: Pain intensity and pain interference'}], 'secondaryOutcomes': [{'measure': 'Opioids', 'timeFrame': '21 Days', 'description': 'Quantity of prescription opioids taken'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'A 3-arm randomized trial where all chronic pain patients will receive honest placebos, but the information about the placebos will differ between conditions. Outcomes are measured for 21 days and a qualitative survey will be conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* chronic pain\n* 18 years old\n* English speaking\n* have a smartphone or computer with video access\n* Taking prescription opioids for chronic pain\n* the chronic pain is concentrated into the patient's lower back.\n\nExclusion Criteria:\n\n* suspect an allergy to any placebo ingredient\n* problematic substance use\n* cancer diagnosis causing pain\n* anticipated change in opioid script during the study period."}, 'identificationModule': {'nctId': 'NCT05952960', 'briefTitle': 'Optimizing Open Label Placebo Rationales', 'organization': {'class': 'OTHER', 'fullName': 'Rhode Island Hospital'}, 'officialTitle': 'Optimizing Open Label Placebo Rationales for Chronic Pain', 'orgStudyIdInfo': {'id': '196178'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'TAU Rationale', 'description': 'Rationale based on prior OLP studies (e.g. Kaptchuk et al., 2010)', 'interventionNames': ['Other: Placebo']}, {'type': 'OTHER', 'label': 'Mindfulness Rationale', 'description': 'Rationale based on mindfulness meditation', 'interventionNames': ['Other: Placebo']}, {'type': 'OTHER', 'label': 'Suspension of Disbelief Rationale', 'description': 'Rationale based on suspending disbelief about the placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'OTHER', 'description': 'Open Label Placebo + Rationale', 'armGroupLabels': ['Mindfulness Rationale', 'Suspension of Disbelief Rationale', 'TAU Rationale']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02912', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rhode Island Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}