Combination of an Investigational Cannabinoid and Methadone for HIV-Associated Neuropathy - Tabular View

Tracking Information

First Received Date ^ICMJE

July 28, 2008

Last Updated Date

February 4, 2009

Start Date ^ICMJE

April 2009

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00723918 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study

Condition ^ICMJE

HIV-Associated Neuropathy
Polyneuropathy

Intervention ^ICMJE

Drug: SAB378
Drug: methadone
Drug: SAB placebo
Drug: Methadone placebo

Study Arms / Comparison Groups

Active Comparator: methadone plus SAB placebo
Experimental: methadone plus active SAB
Placebo Comparator: methadone placebo plus SAB placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2011

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Mary Gould, RN, BA	314-747-8426	gouldm@neuro.wustl.edu
Contact: Nancy Green	314-747-8423	greenn@neuro.wustl.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00723918

Responsible Party

David B. Clifford, MD, Professor of Neurology, Washington University, PI, Neurologic AIDS Research Consortium

Study ID Numbers ^ICMJE

U01NS32228_NARC011, NARC 011

Study Sponsor ^ICMJE

Washington University School of Medicine

Collaborators ^ICMJE

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators ^ICMJE

Principal Investigator:

David B. Clifford, MD

Professor of Neurology, Washington University

Information Provided By

National Institute of Neurological Disorders and Stroke (NINDS)

Verification Date

February 2009

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