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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00723918
Recruitment Status : Terminated (Withdrawal of pharmaceutical support from Novartis - no participants randomized)
First Posted : July 29, 2008
Last Update Posted : January 12, 2011
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
HIV-associated Neuropathy Polyneuropathy Drug: SAB378 Drug: methadone Drug: SAB placebo Drug: Methadone placebo Phase 2

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.

Study Design

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
Primary Completion Date : January 2010
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Effect on quality of life, emotional functioning, cognitive functioning, safety [ Time Frame: At the end of each 4-week treatment period ]

Eligibility Criteria

Information from the National Library of Medicine

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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
Contacts and Locations

Information from the National Library of Medicine

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
AIDS Research Alliance
Los Angeles, California, United States
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
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
Montefiore Medical Center
Bronx, New York, United States
University of New York Downstate Medical Center
Brooklyn, New York, United States, 11208
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
Sponsors and Collaborators
Washington University School of Medicine
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: David B. Clifford, MD Professor of Neurology, Washington University
More Information

Responsible Party: David B. Clifford, MD, Professor of Neurology, Washington University, PI, Neurologic AIDS Research Consortium
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: January 12, 2011
Last Verified: January 2011

Keywords provided by Washington University School of Medicine:
HIV-associated neuropathy
distal sensory polyneuropathy

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents