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

This study has been terminated.
(Withdrawal of pharmaceutical support from Novartis - no participants randomized)
Sponsor:
Collaborator:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00723918
First received: July 28, 2008
Last updated: January 11, 2011
Last verified: January 2011

July 28, 2008
January 11, 2011
April 2009
January 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00723918 on ClinicalTrials.gov Archive Site
Effect on quality of life, emotional functioning, cognitive functioning, safety [ Time Frame: At the end of each 4-week treatment period ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Combination of an Investigational Cannabinoid and Methadone for HIV-associated Neuropathy
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • HIV-associated Neuropathy
  • Polyneuropathy
  • 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.
  • Drug: SAB placebo
    an inactive substance
  • Drug: Methadone placebo
    Methadone placebo
  • Active Comparator: 1
    methadone plus SAB placebo
    Interventions:
    • Drug: methadone
    • Drug: SAB placebo
  • Experimental: 2
    methadone plus active SAB
    Interventions:
    • Drug: SAB378
    • Drug: methadone
  • Placebo Comparator: 3
    methadone placebo plus SAB placebo
    Interventions:
    • Drug: SAB placebo
    • Drug: Methadone placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
0
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00723918
U01NS32228_NARC011, NARC 011
Yes
David B. Clifford, MD, Professor of Neurology, Washington University, PI, Neurologic AIDS Research Consortium
Washington University School of Medicine
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: David B. Clifford, MD Professor of Neurology, Washington University
Washington University School of Medicine
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP