Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-28 @ 10:40 PM
Study NCT ID:
NCT06931158
Status:
RECRUITING
Last Update Posted:
2025-04-27
First Post:
2025-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HOnest Placebos With Explanations: Evaluating Open-Label Placebos for Chronic Pain
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064866', 'term': 'Mindfulness'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Participants are blind to the research hypothesis but not to treatment allocation that are by definition open.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 340}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2025-04-01', 'studyFirstSubmitQcDate': '2025-04-08', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Placebo use', 'timeFrame': 'across 21 days'}], 'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'across 42 days', 'description': 'Single-item assessing current pain level from 0 (min value) to 10 (max value). Higher scores indicate more pain intensity'}], 'secondaryOutcomes': [{'measure': 'Pain interference', 'timeFrame': 'across 42 days', 'description': 'Pain Interference subscale from Brief Pain Inventory Pain interference is measured for general activity, mood, walking ability, work, relationships, sleep, and enjoyment of life on a 0-10 NRS with 0 = "does not interfere" and 10 = "completely interferes" Higher scores indicated greater pain intensity or greater interference with function.'}, {'measure': 'Pain catastrophizing', 'timeFrame': 'across 42 days', 'description': 'Single item assessing how much the patient catastrophizes about their pain from 0 (minimum) to 10 (maximum). Higher scores indicate more catastrophizing.\n\n13 items rated on 5-point Likert scales, from (0) not at all to (4) all the time Higher score indicates higher level of catastrophizing\n\nItem scores are summed into a total score (PCS-T) and three subscale scores:\n\n* Rumination (PCS-R): Items 8, 9, 10, and 11\n* Magnification (PCS-M): Items 6, 7, 13\n* Helplessness (PCS-H): Items 1, 2, 3, 4, 5, and 12 Minimum total score = 0, maximum total score = 52 Subscale score ranges: PCS-R: 0-16; PCS-M: 0-12; PCS-H: 0-24 A total score above 30 indicates clinically relevant level of catastrophizing'}, {'measure': 'Prescription Medication use (including opioids)', 'timeFrame': 'across 42 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['open-label placebo', 'rationales', 'placebo effect'], 'conditions': ['Chronic Low-back Pain', 'Chronic Pain']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to examine the effect of rationale condition when taking open-label placebos on pain by 1) comparing each rationale to the no rationale control condition and the no treatment control condition; and 2) comparing the rationale conditions to each other. We also aim to examine the effect of rationale condition on prescription opioid use by 1) comparing each rationale to the no rationale control condition and the no treatment control condition; and 2) comparing the rationale conditions to each other.\n\nThis study will include patients with chronic low back pain. The main question it aims to answer is:\n\nHow do rationales influence the effects of open-label placebos?\n\nResearchers will compare different rationales given when taking an open-label placebo and a no-treatment group and a no rationale group taking OLPs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria are:\n\n* chronic pain (pain lasting at least 3 months, pain intensity 4/10 or over and interference 3/10 or over)\n* at least 18 years old\n* English speaking\n* have a smartphone or computer with video access\n* the chronic pain is concentrated into the patient's lower back (tentative criteria based on recruitment rate)\n\nExclusion Criteria\n\n* Have chronic pain because of a cancer diagnosis\n* Over 89 years of age\n* Suspect an allergy to any placebo ingredient\n* Currently receiving worker's compensation."}, 'identificationModule': {'nctId': 'NCT06931158', 'acronym': 'HOPE', 'briefTitle': 'HOnest Placebos With Explanations: Evaluating Open-Label Placebos for Chronic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Rhode Island Hospital'}, 'officialTitle': 'Optimizing Open Placebos for Chronic Pain Patients', 'orgStudyIdInfo': {'id': 'RIH-2053624-7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OLP + Standard Rationale', 'description': 'Participants in this group will receive an open-label placebo along with information based on the standard rationales used in other OLP studies.', 'interventionNames': ['Drug: Open-label Placebo', 'Behavioral: Standard Rationale']}, {'type': 'EXPERIMENTAL', 'label': 'OLP + Mindfulness Rationale', 'description': 'Participants in this group will receive an open-label placebo along with information with mindfulness information.', 'interventionNames': ['Drug: Open-label Placebo', 'Behavioral: Mindfulness']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'OLP + Control Rationale', 'description': 'Participants in this group will receive an open-label placebo along with no information on the placebo effect.. They will receive basic epidemiological information on chronic pain to guarantee structural equivalence of the trial design.', 'interventionNames': ['Drug: Open-label Placebo', 'Behavioral: Control Rationale']}, {'type': 'SHAM_COMPARATOR', 'label': 'No Treatment + Control Rationale', 'description': 'Participants in this group will receive no treatment. They will receive basic epidemiological information on chronic pain to guarantee structural equivalence of the trial design.', 'interventionNames': ['Behavioral: Control Rationale']}], 'interventions': [{'name': 'Open-label Placebo', 'type': 'DRUG', 'otherNames': ['OLP', 'Zeebo'], 'description': 'Open-label placebo pill for 21 days at 2 per day', 'armGroupLabels': ['OLP + Control Rationale', 'OLP + Mindfulness Rationale', 'OLP + Standard Rationale']}, {'name': 'Standard Rationale', 'type': 'BEHAVIORAL', 'description': 'Scientific rationale about the placebo effect', 'armGroupLabels': ['OLP + Standard Rationale']}, {'name': 'Mindfulness', 'type': 'BEHAVIORAL', 'description': 'Mindfulness based rationale', 'armGroupLabels': ['OLP + Mindfulness Rationale']}, {'name': 'Control Rationale', 'type': 'BEHAVIORAL', 'description': 'Basic epidemiological information about chronic pain to achieve structural equivalence for the control groups', 'armGroupLabels': ['No Treatment + Control Rationale', 'OLP + Control Rationale']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'HOPE Study', 'role': 'CONTACT', 'email': 'HOPE-trial@lifespan.org', 'phone': '401-606-4766'}], 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'centralContacts': [{'name': 'Study Coordination', 'role': 'CONTACT', 'email': 'HOPE-trial@lifespan.org', 'phone': '401-606-4766'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rhode Island Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Michael Bernstein', 'investigatorAffiliation': 'Rhode Island Hospital'}}}}