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

Purpose

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	Intervention	Phase
HIV-associated Neuropathy Polyneuropathy	Drug: SAB378 Drug: methadone Drug: SAB placebo Drug: Methadone placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Genetics Home Reference related topics: Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	0
Study Start Date:	April 2009
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723918

Locations

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)

Investigators

Principal Investigator:

David B. Clifford, MD

Professor of Neurology, Washington University

More Information

No publications provided

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
Study First Received:	July 28, 2008
Last Updated:	January 11, 2011
Health Authority:	United States: Food and Drug Administration

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
Demyelinating Diseases
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Neuromuscular Diseases
Nervous System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders
Methadone

Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on March 10, 2013