Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2026-01-04 @ 3:44 PM
Study NCT ID:
NCT06442566
Status:
RECRUITING
Last Update Posted:
2025-11-05
First Post:
2024-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ACTION: Trial of Adding Buprenorphine, CBT, and TMS to Improve Outcomes of Long-Term Opioid Therapy 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': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Arm 1 open label, double blind procedures for randomization of BUP and TMS'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'SMART'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-03', 'studyFirstSubmitDate': '2024-05-29', 'studyFirstSubmitQcDate': '2024-05-29', 'lastUpdatePostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Buprenorphine Tolerability', 'timeFrame': 'up to Day-13', 'description': 'Tolerability of open-label transdermal buprenorphine. Buprenorphine tolerability defined as the proportion of patients who do not discontinue buprenorphine due to adverse effects or intolerance.'}, {'measure': 'Pain Severity -with Buprenorphine Patch', 'timeFrame': 'up to Day-20', 'description': 'Pain severity is measured by the Brief Pain Inventory (BPI) Severity Scale and is typically scored as the mean of the four severity items ("average," "worst," "usual," "now," range 0-10) with a higher score being worse.'}], 'secondaryOutcomes': [{'measure': 'Buprenorphine Transition Rate', 'timeFrame': 'Day-20', 'description': 'Buprenorphine transition rate defined as the proportion of participants who spontaneously elect to continue buprenorphine after Phase I.'}, {'measure': 'Quality of Life -with Buprenorphine Patch', 'timeFrame': 'up to Day-20', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference (PROPr) score summarizes multiple domains into a single score anchored at 0 (as bad as dead) and 1 (perfect or ideal health). This score quantifies the value that individuals place on different states of health.\n\nPROPr is calculated from the scores for the 7 PROMIS domains: Cognition, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Ability to Participate in Social Roles and Activities.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['opioids, long-term opioid use, chronic pain, TMS'], 'conditions': ['Opioid Withdrawal', 'Chronic Pain']}, 'descriptionModule': {'briefSummary': 'This study will sequentially evaluate three novel and scalable interventions for at-risk individuals on long term opioid therapy for chronic pain: (1) low-dose transdermal buprenorphine initiation without a period of opioid withdrawal; (2) a brief Cognitive Behavioral Intervention for pain (CBI); and (3) "accelerated" rTMS over the left dorsolateral prefrontal cortex, by examining standardized repeated measures of clinical outcomes at baseline, during treatment, and at 4-, 12-, 24- and 52-week follow-up.', 'detailedDescription': 'With little evidence available to guide the provision of clinical care for patients on long-term opioid therapy (LTOT) in whom the risks outweigh the benefits, major questions remain about optimizing the risk/benefit profile of LTOT, including: how to best engage patients voluntarily in this process; the safety, tolerability and effectiveness of newer treatment approaches; and optimal treatment selection. The primary objective of the proposed study is to begin to systematically address gaps in this important area to improve pain, reduce risk, and improve quality of life for individuals on LTOT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\nAge \\>/= 18 years\n\nEnglish-speaking\n\nOn LTOT, defined as taking daily prescription opioid therapy for 90 days or more\n\nPast week average morphine equivalent dose (MED) \\>/= 20mg\n\nWilling and able to complete written informed consent\n\nWilling and able to use a mobile/cell phone\n\nHave at least one additional risk for opioid toxicity or overdose from the following list:\n\nOpioid Toxicity or Overdose Risks:\n\n1. Taking benzodiazepines with opioids\n2. Substance Use Disorder diagnosis \\[non-tobacco; Opioid Risk Tool\\]\n\n2\\) Having ever experienced an overdose 4) Current major medical problem \\[e.g. mod-severe liver disease, pancreatitis, chronic pulmonary disease, untreated sleep apnea, hospitalized for an acute medical issue in the past 6 months\\]a,b 5) Response to BPI Item 8 \\<30%, suggesting less than moderately clinically meaningful response to pain treatmentc 6) Co-morbid psychiatric diagnosis \\[Opioid Risk Tool\\] 7) Signs of opioid misuse \\[any score \\>0 on the following COMM Items: 3,4,5,9,10,11,14,15,16\\] 8)Opioid Risk Tool \\>3 or Current Opioid Misuse Measure ≥ 9 9) Struggling with any of the following side effects from opioids \\[self-report\\]\n\n1. Dizziness and/or falls\n2. Difficult-to-manage stomach pain, nausea, constipation or GI issues\n3. Fatigue or low energy\n4. Sleepiness or sedation\n5. Trouble with memory or thinking clearly \\[COMM Item 1\\>0\\]\n6. Other troublesome side effect \\[open answer\\]\n\nExclusion criteria:\n\nKnown allergy to buprenorphine\n\nActive moderate or severe substance use disorder with the exception of those listed below:\n\n1. . Those with nicotine use disorder.\n2. . Those meeting criteria for prescription opioid use disorder using only prescribed opioids will be considered on a case-by-case basis.\n\nCognitive disorder limiting ability to consent or fully participate in the brief cognitive intervention\n\nReceiving methadone or buprenorphine treatment for OUD or pain\n\nTaking naltrexone\n\nPregnancy\n\nCurrently incarcerated\n\nTaking medications that prolong QTc interval, as determined by study investigators\n\nPersonal/immediate family history of Long QT Syndrome.\n\nSignificant or unstable condition/s or treatments that may impact safe participation in the study (as determined by the study investigators) such as significant cardiac condition (e.g. poorly-controlled heart failure, current or past cardiac arrhythmia, sustained systolic blood pressure \\>180), significant metabolic disorder (e.g. labile diabetes, significant electrolyte abnormality), cancer (e.g. brain cancer, chemotherapy-induced cognitive impairment), major psychiatric disorder (e.g. active bipolar disorder, schizophrenia spectrum or other psychotic disorder, suicidal/homicidal intent within the past month, or any suicide attempts within the past year or current active suicidal ideation, as determined by medical clinician), developmental disorder (e.g. autism spectrum disorder, intellectual disability), or other neurologic disease (e.g. movement disorder, multiple sclerosis, moderate to severe brain injury).\n\nEnrolled in a clinical trial or has received an investigational medication or device in the last 30 days.\n\nTMS contraindications (e.g., ferromagnetic implants, conditions or treatments that lower seizure threshold, taking contraindicated medications, no identifiable motor threshold, as determined by study investigators).'}, 'identificationModule': {'nctId': 'NCT06442566', 'acronym': 'ACTION', 'briefTitle': 'ACTION: Trial of Adding Buprenorphine, CBT, and TMS to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Sequential Trial of Adding Buprenorphine, Cognitive Behavioral Treatment, and Transcranial Magnetic Stimulation to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain (ACTION)', 'orgStudyIdInfo': {'id': 'Pro00130123'}, 'secondaryIdInfos': [{'id': '1R01DA058620', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA058620', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'open label BUP', 'interventionNames': ['Drug: Buprenorphine Patch']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Real vs Placebo BUP', 'interventionNames': ['Drug: Buprenorphine Patch', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Real vs Sham TMS', 'interventionNames': ['Device: Transcranial Magnetic Stimulation (TMS)', 'Device: Sham Transcranial Magnetic Stimulation (TMS)']}], 'interventions': [{'name': 'Buprenorphine Patch', 'type': 'DRUG', 'description': "Buprenorphine patch dosing will be individualized based on each participant's current morphine-equivalent dose (per package insert/recommendations; between 5mcg and 20mcg per hour). Dosage based on baseline MEQ (\\<30 MEQ = 5mcg/hr patch, 30-80 MEQ =10-15mcg/hour patch; \\>80 MEQ = 20mcg/hour patch), which will remain on for 7 days (Phase Ia Days 1-7), as tolerated", 'armGroupLabels': ['Real vs Placebo BUP', 'open label BUP']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'double-blinded randomization to placebo or transdermal buprenorphine', 'armGroupLabels': ['Real vs Placebo BUP']}, {'name': 'Transcranial Magnetic Stimulation (TMS)', 'type': 'DEVICE', 'description': 'double-blinded randomization to REAL intermittent theta burst (iTBS) rTMS', 'armGroupLabels': ['Real vs Sham TMS']}, {'name': 'Sham Transcranial Magnetic Stimulation (TMS)', 'type': 'DEVICE', 'description': 'double-blinded randomization to SHAM intermittent theta burst (iTBS) rTMS', 'armGroupLabels': ['Real vs Sham TMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29407', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kelly Barth', 'role': 'CONTACT', 'email': 'stephen@musc.edu'}, {'name': 'Rafael Mendoza', 'role': 'CONTACT', 'email': 'mendozra@musc.edu'}, {'name': 'Kelly Barth', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'centralContacts': [{'name': 'Kelly Barth', 'role': 'CONTACT', 'email': 'stephen@musc.edu', 'phone': '843-792-0686'}, {'name': 'Rafael Mendoza', 'role': 'CONTACT', 'email': 'mendozra@musc.edu'}], 'overallOfficials': [{'name': 'Kelly Barth', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor-Faculty', 'investigatorFullName': 'Kelly Barth', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}