NCT00723918

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2008

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

February 9, 2018

Status Verified

February 1, 2018

Enrollment Period

9 months

First QC Date

July 28, 2008

Last Update Submit

February 8, 2018

Conditions

HIV-associated NeuropathyPolyneuropathy

Keywords

HIV-associated neuropathyHIVAIDScannabinoidCannabismethadonedistal sensory polyneuropathypolyneuropathy

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Effect on quality of life, emotional functioning, cognitive functioning, safety

    At the end of each 4-week treatment period

Study Arms (3)

1

ACTIVE COMPARATOR

methadone plus SAB placebo

Drug: methadoneDrug: SAB placebo

2

EXPERIMENTAL

methadone plus active SAB

Drug: SAB378Drug: methadone

3

PLACEBO COMPARATOR

methadone placebo plus SAB placebo

Drug: SAB placeboDrug: Methadone placebo

Interventions

SAB378DRUG

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

Also known as: SAB
2
methadoneDRUG

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.

12
SAB placeboDRUG

an inactive substance

13
Methadone placeboDRUG

Methadone placebo

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California, San Diego

San Diego, California, 92093, United States

Location

University of New York Downstate Medical Center

Brooklyn, New York, 11208, United States

Location

University of Rochester

Rochester, New York, 14620, United States

Location

MeSH Terms

Conditions

PolyneuropathiesAcquired Immunodeficiency SyndromeMarijuana Abuse

Interventions

nabiximolsMethadone

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

KetonesOrganic Chemicals

Study Officials

  • David B. Clifford, MD

    Professor of Neurology, Washington University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2008

First Posted

July 29, 2008

Study Start

April 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

February 9, 2018

Record last verified: 2018-02

Locations

US(3)