HIV-associated NeuropathyPhase 2NCT00723918
Combination of an Investigational Cannabinoid and Methadone for HIV-associated Neuropathy
A Phase 2 study testing SAB378 and methadone in people with HIV-associated Neuropathy and Polyneuropathy, run by Washington University School of Medicine at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-associated Neuropathy, Polyneuropathy
- What is being tested?
- SAB378 and methadone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2009to Jan 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of New York Downstate Medical Center
Brooklyn, New York, 11208
University of Rochester
Rochester, New York, 14620
University of California, San Diego
San Diego, California, 92093
About this study
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
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.
Read the 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
- Being tested
- SAB378, methadone, SAB placebo, Methadone placebo
- Keywords
- HIV-associated neuropathy, HIV, AIDS, cannabinoid, Cannabis, methadone, distal sensory polyneuropathy, polyneuropathy
- Medical subject headings
- Polyneuropathies, Acquired Immunodeficiency Syndrome, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAB378Drug
Also called SAB
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
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.
SAB placeboDrug
an inactive substance
Methadone placeboDrug
Methadone placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | methadone plus SAB placebo Receives: Drug: methadone; Drug: SAB placebo |
| 2 | Experimental | methadone plus active SAB Receives: Drug: SAB378; Drug: methadone |
| 3 | Placebo comparator | methadone placebo plus SAB placebo Receives: Drug: SAB placebo; Drug: Methadone placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of methadone alone versus methadone and SAB378 for treatment of HIV-associated neuropathy
Measured: At the end of each 4-week treatment period
Secondary outcomes (1)
Effect on quality of life, emotional functioning, cognitive functioning, safety
Measured: At the end of each 4-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startApr 2009
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: Withdrawal of pharmaceutical support from Novartis - no participants randomized
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-associated NeuropathyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David B. Clifford, MD, Principal investigator, Professor of Neurology, Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723918
- Sponsor's protocol ID
- U01NS32228_NARC011
- Other IDs
- NARC 011, U01NS032228
- Status last verified
- Feb 2018
- First submitted
- 28 Jul 2008
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00723918
- Acronym / sponsor ID
- U01NS32228_NARC011
- Conditions
- HIV-associated Neuropathy, Polyneuropathy
- Keywords
- HIV-associated neuropathy, HIV, AIDS, cannabinoid, Cannabis, methadone, distal sensory polyneuropathy, polyneuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawal of pharmaceutical support from Novartis - no participants randomized
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Apr 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 29 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: methadone, Drug: SAB placebomethadone plus SAB placebo |
| 2 | Experimental | Drug: SAB378, Drug: methadonemethadone plus active SAB |
| 3 | Placebo comparator | Drug: SAB placebo, Drug: Methadone placebomethadone placebo plus SAB placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- Active AIDS-defining opportunistic infection within 45 days prior to study entry
- Renal insufficiency
- Chronic liver disease
- B12 deficiency
- Family history of hereditary neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAB378Also: SABSAB 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 | Drug | 2 |
| methadoneMethadone 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. | Drug | 1, 2 |
| SAB placeboan inactive substance | Drug | 1, 3 |
| Methadone placeboMethadone placebo | Drug | 3 |
Primary outcome
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
1 secondary outcome
Effect on quality of life, emotional functioning, cognitive functioning, safety
Time frame: At the end of each 4-week treatment period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
Related trials for HIV-associated Neuropathy
Recruiting
Auricular Vagus Nerve Stimulation Mechanisms for HIV-Associated Peripheral Neuropathy
HIV Associated Polyneuropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David B. Clifford, MD principal investigator
Professor of Neurology, Washington University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAB378 and methadone in people with HIV-associated Neuropathy and Polyneuropathy, run by Washington University School of Medicine at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2018.