Combination of an Investigational Cannabinoid and Methadone for HIV-Associated Neuropathy
Information source: National Institute of Neurological Disorders and Stroke (NINDS)
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV-Associated Neuropathy; Polyneuropathy
Intervention: SAB378 (Drug); methadone (Drug); SAB placebo (Drug); Methadone placebo (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: Washington University School of Medicine Official(s) and/or principal investigator(s):
David B. Clifford, MD, Principal Investigator, Affiliation: Professor of Neurology, Washington University
Overall contact:
Mary Gould, RN, BA, Phone: 314-747-8426, Email: gouldm@neuro.wustl.edu
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: Efficacy of methadone alone versus methadone and SAB378 for treatment of HIV-associated neuropathy
Secondary outcome: Effect on quality of life, emotional functioning, cognitive functioning, safety
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- HIV-1 infection
- HIV-associated neuropathy diagnosed by a neurologist
- Presence of at least a moderate pain score on the basis of completion of a baseline
pain diary
- Stable antiretroviral regimen for at least 8 weeks prior to study entry.
- Hemoglobin ≥ 8. 0 g/dL for males and ≥ 7. 5 g/dL for females
Exclusion Criteria:
- Active AIDS-defining opportunistic infection within 45 days prior to study entry
- Renal insufficiency
- Chronic liver disease
- B12 deficiency
- Family history of hereditary neuropathy
- Discontinuation of dideoxynucleoside NRTI within 16 weeks prior to entry
- On neuroregenerative therapy
- Treatment with neurotoxic drugs within 120 days prior to entry
- Respiratory compromise
- Hypotension
- Active substance abuse or dependence
- History of alcohol-related complications within 6 months prior to screening
- Women of childbearing potential
Locations and Contacts
Mary Gould, RN, BA, Phone: 314-747-8426, Email: gouldm@neuro.wustl.edu
University of California, San Diego, San Diego, California 92093, United States
University of California, San Francisco, San Francisco, California 94122, United States
Stanford University, Stanford, California 94305, United States
Johns Hopkins University, Baltimore, Maryland 21287, United States
Washington University, St. Louis, Missouri 63110, United States
Mount Sinai Medical Center, New York, New York 10029, United States
Weill Medical College of Cornell University, New York, New York 10065, United States
University of Rochester, Rochester, New York 14620, United States
University of New York Downstate Medical Center, Brooklyn, New York 11208, United States
Joseph Gathe, M.D., Houston, Texas 77004, United States
Central Texas Clinical Research, Austin, Texas 78705, United States
Additional Information
Starting date: September 2008
Ending date: June 2011
Last updated: August 4, 2008
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