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Sponsors and Collaborators: |
Washington University School of Medicine National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00723918 |
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.
Condition | Intervention | Phase |
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HIV-Associated Neuropathy Polyneuropathy |
Drug: SAB378 Drug: methadone Drug: SAB placebo Drug: Methadone placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 84 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
methadone plus SAB placebo
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Drug: methadone
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.
Drug: SAB placebo
an inactive substance
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2: Experimental
methadone plus active SAB
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Drug: SAB378
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
Drug: methadone
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.
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3: Placebo Comparator
methadone placebo plus SAB placebo
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Drug: SAB placebo
an inactive substance
Drug: Methadone placebo
Methadone placebo
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Distal sensory polyneuropathy is the most common neurological complication of HIV disease and its treatment. To date no standard effective therapy has been identified.
In 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.
Approximately 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.
This trial is part of the Neurologic AIDS Research Consortium, an effective collaborative clinical study group dedicated to the study of HIV-associated neurological disease.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mary Gould, RN, BA | 314-747-8426 | gouldm@neuro.wustl.edu |
Contact: Nancy Green | 314-747-8423 | greenn@neuro.wustl.edu |
United States, California | |
University of California, San Diego | |
San Diego, California, United States, 92093 | |
University of California, San Francisco | |
San Francisco, California, United States, 94122 | |
Stanford University | |
Stanford, California, United States, 94305 | |
AIDS Research Alliance | |
Los Angeles, California, United States | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21287 | |
United States, Missouri | |
Washington University | |
St. Louis, Missouri, United States, 63110 | |
United States, New York | |
Mount Sinai Medical Center | |
New York, New York, United States, 10029 | |
Weill Medical College of Cornell University | |
New York, New York, United States, 10065 | |
University of Rochester | |
Rochester, New York, United States, 14620 | |
University of New York Downstate Medical Center | |
Brooklyn, New York, United States, 11208 | |
Montefiore Medical Center | |
Bronx, New York, United States |
Principal Investigator: | David B. Clifford, MD | Professor of Neurology, Washington University |
Responsible Party: | Washington University, PI, Neurologic AIDS Research Consortium ( David B. Clifford, MD, Professor of Neurology ) |
Study ID Numbers: | U01NS32228_NARC011, NARC 011 |
Study First Received: | July 28, 2008 |
Last Updated: | February 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00723918 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HIV-associated neuropathy HIV AIDS cannabinoid |
Cannabis methadone distal sensory polyneuropathy polyneuropathy |
Acquired Immunodeficiency Syndrome Polyneuropathies Central Nervous System Depressants Pain Narcotics Naphazoline Methadone Neuromuscular Diseases |
HIV Infections Guaifenesin Peripheral Nervous System Diseases Peripheral Nervous System Agents Phenylpropanolamine Analgesics Analgesics, Opioid |
Respiratory System Agents Nervous System Diseases Physiological Effects of Drugs Polyneuropathies Central Nervous System Depressants Narcotics Pharmacologic Actions Methadone Neuromuscular Diseases |
Sensory System Agents Peripheral Nervous System Diseases Therapeutic Uses Peripheral Nervous System Agents Analgesics Antitussive Agents Central Nervous System Agents Analgesics, Opioid |