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Combination of an Investigational Cannabinoid and Methadone for HIV-associated Neuropathy

Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
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: Terminated

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


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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

AIDS Research Alliance, Los Angeles, California, United States

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

Montefiore Medical Center, Bronx, New York, United States

University of New York Downstate Medical Center, Brooklyn, New York 11208, 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

Additional Information

Starting date: April 2009
Last updated: January 11, 2011

Page last updated: August 23, 2015

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