Combination of an Investigational Cannabinoid and Methado... | NCT00723918

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

NCT00723918

Sponsor

Washington University School of Medicine

Status

Withdrawn

Last Update Posted

Feb 9, 2018Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

HIV-associated Neuropathy
Polyneuropathy

Interventions

SAB378
methadone
SAB placebo
Methadone placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NARC 011
U01NS032228	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Withdrawal of pharmaceutical support from Novartis - no participants randomized

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Jul 28, 2008

First Submission Date that Met QC Criteria

Jul 28, 2008

First Posted Date

Jul 29, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2018

Last Update Posted Date

Feb 9, 2018Actual

Name	Class
National Institute of Neurological Disorders and Stroke (NINDS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	methadone plus SAB placebo	Drug: methadone Drug: SAB placebo
2	Experimental	methadone plus active SAB	Drug: SAB378 Drug: methadone
3	Placebo Comparator	methadone placebo plus SAB placebo	Drug: SAB placebo Drug: Methadone placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SAB378	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy of methadone alone versus methadone and SAB378 for treatment of HIV-associated neuropathy		At the end of each 4-week treatment period

Secondary Outcomes

Measure	Description	Time Frame
Effect on quality of life, emotional functioning, cognitive functioning, safety		At the end of each 4-week treatment period

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David B. Clifford, MD	Professor of Neurology, Washington University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Diego		San Diego	California	92093	United States
University of New York Downstate Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D011115	Polyneuropathies
D000163	Acquired Immunodeficiency Syndrome
D002189	Marijuana Abuse

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D015658	HIV Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C587251	nabiximols
D008691	Methadone

Ancestor Terms

ID	Term
D007659	Ketones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided