Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2026-02-25 @ 8:27 PM
Study NCT ID:
NCT02965768
Status:
WITHDRAWN
Last Update Posted:
2022-09-02
First Post:
2016-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Effects of Low-dose Naltrexone in ME/CFS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015673', 'term': 'Fatigue Syndrome, Chronic'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D004679', 'term': 'Encephalomyelitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009271', 'term': 'Naltrexone'}], 'ancestors': [{'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blind trial. An encrypted and password-protected database will contain (1) information about individual group assignment, and (2) blister pack codes (medication will be dispensed in blister packs by investigators based on these codes). An investigator not involved with data collection or participant interactions will randomly assign individuals to the treatment group and provide blister pack ID codes for each individual.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study was temporarily suspended to focus on other projects, but was never resumed. No participants were determined eligible and none started the protocol.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-30', 'studyFirstSubmitDate': '2016-11-14', 'studyFirstSubmitQcDate': '2016-11-16', 'lastUpdatePostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in plasma inflammatory biomarkers', 'timeFrame': 'Four-week baseline; 12 weeks drug', 'description': 'Levels of plasma IL-1B, TNFa, IL6, IL12, and IL17 will be tested as the primary biomarkers of interest.'}], 'secondaryOutcomes': [{'measure': 'Durability of reduction in plasma inflammatory biomarkers', 'timeFrame': 'Baseline; 12 weeks drug; 24 weeks drug', 'description': 'Levels of plasma IL-1B, TNFa, IL6, IL12, and IL17 will be tested as the primary biomarkers of interest. 24 weeks vs 12 weeks drug.'}, {'measure': 'Reduction in self-reported fatigue', 'timeFrame': '12 weeks drug', 'description': 'Fatigue will be reported daily on a hand-held computer device.'}, {'measure': 'Increase in physical function', 'timeFrame': '12 weeks drug', 'description': 'Physical function will be reported weekly on a Patient-Specific Functional Scale.'}, {'measure': 'Reduction in self-reported symptoms of (i) depression, (ii) anxiety', 'timeFrame': '12 weeks drug', 'description': 'Symptoms of depression and anxiety will be reported weekly on a Hospital Anxiety and Depression Scale.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fatigue Syndrome, Chronic']}, 'referencesModule': {'references': [{'pmid': '24526250', 'type': 'BACKGROUND', 'citation': 'Younger J, Parkitny L, McLain D. The use of low-dose naltrexone (LDN) as a novel anti-inflammatory treatment for chronic pain. Clin Rheumatol. 2014 Apr;33(4):451-9. doi: 10.1007/s10067-014-2517-2. Epub 2014 Feb 15.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to test if naltrexone, when taken in low doses, has an anti-inflammatory effect that may be associated with positive clinical outcomes in people with chronic fatigue syndrome (CFS). In part, the present study, is a continuation of prior work in which we showed that chronic fatigue symptoms are associated with immune activity, and that low-dose naltrexone might exert anti-inflammatory effects in fibromyalgia, which is thought to share some pathophysiological and clinical characteristics with CFS.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1\\. Meet the 1994 Case Definition criteria for CFS (assessed through semi-structured interview and the DePaul University Fatigue Questionnaire):\n\n* Criteria:\n\n * Severe chronic fatigue ≥6 consecutive months not due to ongoing exertion or other medical condition associated with fatigue;\n * Fatigue interferes with daily activities and work;\n * Reports ≥4 symptoms that started with or after the fatigue, from:\n* Post-exertion malaise \\>24 hours\n* Unrefreshing sleep\n* Short-term memory or concentration impairment\n* Muscle pain\n* Joint pain without swelling or redness\n* Headaches of a new type/pattern/severity\n* Lymph node tenderness\n* Frequent or recurring sore throat 3. CFS symptoms for ≥12 months 4. Participant completes daily self-report during the 4-week baseline period; 5. Able to attend UAB on all scheduled appointments\n\nExclusion Criteria:\n\n1. Blood draw contraindicated or otherwise not able to be performed\n2. High-sensitivity c-reactive protein (HS-CRP) ≥3 mg/L\n3. Erythrocyte sedimentation rate (ESR) \\>60 mm/hr\n4. Positive rheumatoid factor\n5. Positive anti-nuclear antibody (ANA)\n6. Levels of thyroid stimulating hormone or free thyroxine outside UAB lab reference values\n7. Diagnosed rheumatological or auto-immune condition\n8. Clotting disorder\n9. Use of blood thinning medication\n10. Oral temperature \\>100˚F at baseline\n11. Febrile illness or use of antibiotics in the 4 weeks before study commencement;\n12. Planned surgery or procedures during the study period, or operated on in the 4 weeks before study commencement\n13. Pregnant or planning on becoming pregnant within 6 months\n14. Regular use of any anti-inflammatory medication (such as aspirin, ibuprofen, naproxen)\n15. Known allergy or adverse effects following naltrexone or naloxone administration\n16. Opioid use (self-reported or positive on urine test)\n17. Significant psychological comorbidity that in the discretion of the investigator compromises study integrity and/or a baseline HADS depression subscale score of ≥16\n18. Current litigation or worker's compensation claim\n19. Current participation in another treatment trial\n20. Vaccinated in the 4 weeks before study commencement (vaccination during the study period is allowed as long as the drug is administered at least 4 weeks prior to a study blood draw)."}, 'identificationModule': {'nctId': 'NCT02965768', 'briefTitle': 'Immune Effects of Low-dose Naltrexone in ME/CFS', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'The Immune Effects of Low-dose Naltrexone in People With Myalgic Encephalopathy/Chronic Fatigue Syndrome (ME/CFS)', 'orgStudyIdInfo': {'id': 'F160525003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LDN arm', 'description': 'Naltrexone HCl 4.5mg (standard-dose) or 3.0mg (optional-dose) x24 weeks', 'interventionNames': ['Drug: Naltrexone HCl']}, {'type': 'OTHER', 'label': 'Placebo/LDN arm', 'description': 'Naltrexone HCl 4.5mg (standard-dose) or 3.0mg (optional-dose) Placebo\n\nIndividuals will be switched between drugs as per approved schedule during the 24 weeks.', 'interventionNames': ['Drug: Naltrexone HCl']}], 'interventions': [{'name': 'Naltrexone HCl', 'type': 'DRUG', 'otherNames': ['Low-dose Naltrexone', 'LDN'], 'description': '4.5 mg Naltrexone HCl, p.o., nocte (standard-dose); 3.0 mg Naltrexone HCl, p.o., nocte (optional-dose);', 'armGroupLabels': ['LDN arm', 'Placebo/LDN arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Jarred Younger, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jarred Younger', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}