Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT00723918
Status:
WITHDRAWN
Last Update Posted:
2018-02-09
First Post:
2008-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination of an Investigational Cannabinoid and Methadone for HIV-associated Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D002189', 'term': 'Marijuana Abuse'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C587251', 'term': 'nabiximols'}, {'id': 'D008691', 'term': 'Methadone'}], 'ancestors': [{'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Withdrawal of pharmaceutical support from Novartis - no participants randomized', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-08', 'studyFirstSubmitDate': '2008-07-28', 'studyFirstSubmitQcDate': '2008-07-28', 'lastUpdatePostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of methadone alone versus methadone and SAB378 for treatment of HIV-associated neuropathy', 'timeFrame': 'At the end of each 4-week treatment period'}], 'secondaryOutcomes': [{'measure': 'Effect on quality of life, emotional functioning, cognitive functioning, safety', 'timeFrame': 'At the end of each 4-week treatment period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV-associated neuropathy', 'HIV', 'AIDS', 'cannabinoid', 'Cannabis', 'methadone', 'distal sensory polyneuropathy', 'polyneuropathy'], 'conditions': ['HIV-associated Neuropathy', 'Polyneuropathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of methadone alone and in combination with SAB378 for the treatment of painful HIV-associated neuropathy.', 'detailedDescription': 'Distal sensory polyneuropathy is the most common neurological complication of HIV disease and its treatment. To date no standard effective therapy has been identified.\n\nIn this study, scientists will evaluate the effectiveness of treating HIV-associated neuropathy with methadone alone and in combination with a novel cannabinoid SAB378. A cannabinoid is a molecule found only in the Cannabis plant. Cannabis and some cannabinoids are effective analgesics or pain relievers. The rationale for combination therapy is twofold: (1) medications with unique mechanisms of action may affect different aspects of neuropathic pain and (2) combination therapy may act synergistically-meaning the combined effect may be greater than the effect of each drug alone.\n\nApproximately 84 participants will be enrolled in this double-blind, placebo-controlled, crossover study. Participants will be randomly assigned to three treatment groups-those receiving methadone and SAB378 placebo (an inactive substance), those receiving methadone and active SAB378, or those receiving methadone placebo and SAB378 placebo. All participants will be exposed to each of the 3 treatment groups during the study.\n\nThis trial is part of the Neurologic AIDS Research Consortium, an effective collaborative clinical study group dedicated to the study of HIV-associated neurological disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1 infection\n* HIV-associated neuropathy diagnosed by a neurologist\n* Presence of at least a moderate pain score on the basis of completion of a baseline pain diary\n* Stable antiretroviral regimen for at least 8 weeks prior to study entry.\n* Hemoglobin ≥ 8.0 g/dL for males and ≥ 7.5 g/dL for females\n\nExclusion Criteria:\n\n* Active AIDS-defining opportunistic infection within 45 days prior to study entry\n* Renal insufficiency\n* Chronic liver disease\n* B12 deficiency\n* Family history of hereditary neuropathy\n* Discontinuation of dideoxynucleoside NRTI within 16 weeks prior to entry\n* On neuroregenerative therapy\n* Treatment with neurotoxic drugs within 120 days prior to entry\n* Respiratory compromise\n* Hypotension\n* Active substance abuse or dependence\n* History of alcohol-related complications within 6 months prior to screening\n* Women of childbearing potential'}, 'identificationModule': {'nctId': 'NCT00723918', 'briefTitle': 'Combination of an Investigational Cannabinoid and Methadone for HIV-associated Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'NARC 011: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Methadone and Combination of Methadone and SAB378 in HIV-associated Painful Peripheral Neuropathy', 'orgStudyIdInfo': {'id': 'U01NS32228_NARC011'}, 'secondaryIdInfos': [{'id': 'NARC 011'}, {'id': 'U01NS032228', 'link': 'https://reporter.nih.gov/quickSearch/U01NS032228', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'methadone plus SAB placebo', 'interventionNames': ['Drug: methadone', 'Drug: SAB placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'methadone plus active SAB', 'interventionNames': ['Drug: SAB378', 'Drug: methadone']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'methadone placebo plus SAB placebo', 'interventionNames': ['Drug: SAB placebo', 'Drug: Methadone placebo']}], 'interventions': [{'name': 'SAB378', 'type': 'DRUG', 'otherNames': ['SAB'], 'description': 'SAB 15 mg per day for 5 days, the 15 mg BID (twice a day) for 5 days, then 15 mg TID (three times a day) to end of 28-day treatment period, in combination with active methadone 5 mg BID for 5 days, then 5 mg TID for 5 days, to maximum of 10 mg TID until end of 28-day treatment period', 'armGroupLabels': ['2']}, {'name': 'methadone', 'type': 'DRUG', 'description': 'Methadone 5 mg BID (twice a day) for 5 days, then 5 mg TID (three times a day) for 5 days, to maximum of 10 mg TID, in combination with SAB placebo or SAB active drug titrated as above, to end of 28-day treatment period.', 'armGroupLabels': ['1', '2']}, {'name': 'SAB placebo', 'type': 'DRUG', 'description': 'an inactive substance', 'armGroupLabels': ['1', '3']}, {'name': 'Methadone placebo', 'type': 'DRUG', 'description': 'Methadone placebo', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '11208', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'University of New York Downstate Medical Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'David B. Clifford, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Neurology, Washington University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}