Polyneuropathy Clinical Trial
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
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.
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.
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