Combination of an Investigational Cannabinoid and Methadone for HIV-associated Neuropathy
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ClinicalTrials.gov Identifier: NCT00723918 |
Recruitment Status
:
Withdrawn
(Withdrawal of pharmaceutical support from Novartis - no participants randomized)
First Posted
: July 29, 2008
Last Update Posted
: February 9, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV-associated Neuropathy Polyneuropathy | Drug: SAB378 Drug: methadone Drug: SAB placebo Drug: Methadone placebo | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | April 2009 |
Actual Primary Completion Date : | January 2010 |
Actual Study Completion Date : | January 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
methadone plus SAB placebo
|
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
|
Experimental: 2
methadone plus active SAB
|
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
Other Name: SAB
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.
|
Placebo Comparator: 3
methadone placebo plus SAB placebo
|
Drug: SAB placebo
an inactive substance
Drug: Methadone placebo
Methadone placebo
|
- Efficacy of methadone alone versus methadone and SAB378 for treatment of HIV-associated neuropathy [ Time Frame: At the end of each 4-week treatment period ]
- Effect on quality of life, emotional functioning, cognitive functioning, safety [ Time Frame: At the end of each 4-week treatment period ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00723918
United States, California | |
University of California, San Diego | |
San Diego, California, United States, 92093 | |
United States, New York | |
University of New York Downstate Medical Center | |
Brooklyn, New York, United States, 11208 | |
University of Rochester | |
Rochester, New York, United States, 14620 |
Principal Investigator: | David B. Clifford, MD | Professor of Neurology, Washington University |
Responsible Party: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00723918 History of Changes |
Other Study ID Numbers: |
U01NS32228_NARC011 NARC 011 |
First Posted: | July 29, 2008 Key Record Dates |
Last Update Posted: | February 9, 2018 |
Last Verified: | February 2018 |
Keywords provided by Washington University School of Medicine:
HIV-associated neuropathy HIV AIDS cannabinoid |
Cannabis methadone distal sensory polyneuropathy polyneuropathy |
Additional relevant MeSH terms:
Peripheral Nervous System Diseases Polyneuropathies Neuromuscular Diseases Nervous System Diseases Methadone Analgesics, Opioid Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Antitussive Agents Respiratory System Agents |