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

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00723918
• Other study ID #: U01NS32228_NARC011
• Secondary ID: NARC 011
• Status: Withdrawn
• Phase: Phase 2
• First received: July 28, 2008
• Last updated: February 8, 2018
• Start date: April 2009
• Est. completion date: January 2010

Study information

• Verified date: February 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV-associated Neuropathy
• Peripheral Nervous System Diseases
• Polyneuropathies
• Polyneuropathy

Intervention

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
• 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.
• SAB placebo
an inactive substance
• Methadone placebo
Methadone placebo

Locations

Country	Name	City	State
United States	University of New York Downstate Medical Center	Brooklyn	New York
United States	University of Rochester	Rochester	New York
United States	University of California, San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of methadone alone versus methadone and SAB378 for treatment of HIV-associated neuropathy		At the end of each 4-week treatment period
Secondary	Effect on quality of life, emotional functioning, cognitive functioning, safety		At the end of each 4-week treatment period