Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-27 @ 11:59 PM
Study NCT ID:
NCT05477004
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-19
First Post:
2022-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of Ketamine Infusions for the Treatment of Chronic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D013001', 'term': 'Somatoform Disorders'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D020918', 'term': 'Complex Regional Pain Syndromes'}, {'id': 'D010148', 'term': 'Pain, Intractable'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2022-07-21', 'studyFirstSubmitQcDate': '2022-07-25', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline opioid use; measured with 2 questions', 'timeFrame': '1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)', 'description': 'Question 1: Participants are asked whether they have used any opioid medications since their last ketamine infusion (yes/no). Question 2: Participants are asked to rate how their opioid use has changed on a 4-point scale ranging from "I have not used any opioids since my last ketamine infusion" to "I am using more opioids after my last ketamine infusion."'}, {'measure': 'Change from baseline pain catastrophizing score; measured with Pain Catastrophizing Scale - Short Form', 'timeFrame': '1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)', 'description': 'Pain Catastrophizing Scale - Short Form is a 4-item scale with a total score ranging from 0-16, with higher scores indicative of more catastrophizing.'}, {'measure': 'Change from baseline pain interference score; measured with PROMIS Pain Interference', 'timeFrame': '1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)', 'description': 'PROMIS Pain Interference is a computerized adaptive test with results reported as a T-score (mean score of 50 and standard deviation of 10), with higher T-scores indicative of more pain interference.'}, {'measure': 'Change from baseline physical function score; measured with PROMIS Physical Function', 'timeFrame': '1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)', 'description': 'PROMIS Physical Function is a computerized adaptive test with results reported as a T-score (mean score of 50 and standard deviation of 10), with higher T-scores indicative of better physical function.'}, {'measure': 'Change from baseline depression score; measured with PROMIS Depression', 'timeFrame': '1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)', 'description': 'PROMIS Depression is a computerized adaptive test with results reported as a T-score (mean score of 50 and standard deviation of 10), with higher T-scores indicative of more depression.'}, {'measure': 'Change from baseline anxiety score; measured with PROMIS Anxiety', 'timeFrame': '1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)', 'description': 'PROMIS Anxiety is a computerized adaptive test with results reported as a T-score (mean score of 50 and standard deviation of 10), with higher T-scores indicative of more anxiety.'}, {'measure': 'Change from baseline sleep disturbance score; measured with PROMIS Sleep Disturbance', 'timeFrame': '1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)', 'description': 'PROMIS Sleep Disturbance is a computerized adaptive test with results reported as a T-score (mean score of 50 and standard deviation of 10), with higher T-scores indicative of more sleep disturbance.'}, {'measure': 'Change from baseline global health score; measured with PROMIS Global Health', 'timeFrame': '1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)', 'description': 'PROMIS Global Health is a computerized adaptive test with results reported as a T-score (mean score of 50 and standard deviation of 10), with higher T-scores indicative of better overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life.'}, {'measure': 'Change from baseline body areas affected by pain; measured with CHOIR Body Map', 'timeFrame': '1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)', 'description': 'CHOIR Body Map is a validated self-report body map where participants select areas of the body affected by pain, with a higher number of selected areas indicative of more widespread pain.'}], 'primaryOutcomes': [{'measure': 'Change from baseline Patient Global Impression of Change (PGIC) in overall status; measured with PGIC Scale', 'timeFrame': '1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)', 'description': 'The PGIC Scale is a single-question 7-point Likert scale ranging from "Very much improved" to "Very much worse."'}], 'secondaryOutcomes': [{'measure': 'Change from baseline average pain intensity; measured with Numeric Rating Scale (NRS)', 'timeFrame': '1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)', 'description': 'Participants rate their average pain intensity over the last 7 days using whole numbers on a 0-to-10 scale, with higher values indicative of more pain.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ketamine', 'chronic pain', 'pain syndrome', 'neuropathic pain', 'complex regional pain syndrome', 'intractable pain'], 'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'This observational study will collect prospectively specified data on patient characteristics and clinically relevant outcomes in patients who receive a ketamine infusion at Stanford Pain Management Center for the treatment of chronic pain, with the goal of identifying treatment responders and relationships between patient characteristics and treatment response.', 'detailedDescription': 'Ketamine is a type of anesthetic drug which has been used off-label to treat chronic pain. The effectiveness of intravenous ketamine and its duration of effect are not well-understood. There is high variability in response to ketamine, and it remains unclear which patient characteristics are associated with favorable outcomes. This observational study will collect a wide range of patient-reported outcomes via digital surveys: once at baseline before treatment, and up to 7 follow-up surveys for up to 12 months following a single ketamine infusion. Survey data will be supplemented by clinical data obtained from electronic medical records.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "This study population consists of adults who receive a ketamine infusion for the treatment of any chronic pain condition. All patients who are scheduled for a ketamine infusion through Stanford's Pain Management Center during this study's enrollment period are contacted for screening.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has been seen at Stanford's Pain Management Center for a doctor's visit at least once.\n* Is scheduled to undergo at least 1 ketamine infusion for the treatment of any chronic pain condition.\n* Have a valid email address and consents to receiving surveys by email.\n* Able to read, understand, and respond to English-language surveys on an electronic device such as a cell phone, tablet, or computer.\n* Able to read, understand, and provide written, dated informed consent.\n\nExclusion Criteria:\n\n* Has their ketamine infusion cancelled, which may occur before or after consenting to this study."}, 'identificationModule': {'nctId': 'NCT05477004', 'briefTitle': 'Observational Study of Ketamine Infusions for the Treatment of Chronic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Ketamine Infusion for the Treatment Chronic Pain in Adults: a Prospective Observational Study to Characterize Predictors and Outcomes', 'orgStudyIdInfo': {'id': '62561'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Open label ketamine', 'description': 'Patients who receive a ketamine infusion for the treatment of chronic pain in the course of usual clinical care', 'interventionNames': ['Drug: Ketamine']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'otherNames': ['Ketalar'], 'description': 'A multi-day continuous ketamine infusion delivered intravenously at subanesthetic doses in a monitored setting', 'armGroupLabels': ['Open label ketamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Theresa Lii, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ANALYTIC_CODE'], 'timeFrame': 'Immediately following publication. No end date.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in the publication, after deidentification (text, tables, figures, and appendices).', 'accessCriteria': 'IPD may be shared upon reasonable request to researchers who provide a methodologically sound proposal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Theresa Lii', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Scholar', 'investigatorFullName': 'Theresa Lii', 'investigatorAffiliation': 'Stanford University'}}}}