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

NCT ID: NCT00723918

Last Updated: 2018-02-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-01-31

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.

Conditions

HIV-associated Neuropathy; Polyneuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

methadone plus SAB placebo

Group Type: ACTIVE_COMPARATOR

methadone

Intervention Type: DRUG

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

Intervention Type: DRUG

an inactive substance

2

methadone plus active SAB

Group Type: EXPERIMENTAL

SAB378

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

3

methadone placebo plus SAB placebo

Group Type: PLACEBO_COMPARATOR

SAB placebo

Intervention Type: DRUG

an inactive substance

Methadone placebo

Intervention Type: DRUG

Methadone placebo

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

SAB placebo

an inactive substance

Intervention Type: DRUG

Methadone placebo

Methadone placebo

Intervention Type: DRUG

Other Intervention Names

SAB

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David B. Clifford, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Neurology, Washington University

Locations

University of California, San Diego

San Diego, California, United States

University of New York Downstate Medical Center

Brooklyn, New York, United States

University of Rochester

Rochester, New York, United States

Countries

United States

Other Identifiers

NARC 011

Identifier Type: -

Identifier Source: secondary_id

U01NS032228

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01NS32228_NARC011

Identifier Type: -

Identifier Source: org_study_id