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Opioid Antagonist

Low Dose Naltrexone for Pain in HIV/AIDS

Phase 4

Recruiting

Led By Anne M McKenzie-Brown, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pain score > 4/10 on average on the NPRS lasting > 3 months

HIV infection with a viral load of < 1000 copies/ml for the past six months

Must not have

Nursing mothers and women of childbearing potential not using highly effective contraception

Diagnosis of liver disease, e.g. cirrhosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,11 and 12

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test whether low-dose naltrexone, an opioid antagonist usually used in the treatment of alcohol and opioid use disorders, can relieve chronic pain in people living with HIV/AIDS. If successful, this inexpensive repurposing of the drug could expand access to treatment for a painful condition experienced by many people with HIV/AIDS.

Who is the study for?

This trial is for adults aged 18-65 with HIV and chronic neuropathic pain, who have a viral load under 1000 copies/ml. Participants must be fluent in English and willing to follow study rules. Excluded are those using opioids or at risk of needing them, with allergies to naltrexone, severe liver or kidney disease, certain psychiatric conditions, active substance abuse disorders, pregnant/nursing women, or not using effective contraception.

What is being tested?

The trial tests Low Dose Naltrexone (LDN) as a treatment for chronic pain in patients living with HIV/AIDS. LDN is an immune modulator that may reduce pain by affecting the immune system without the adverse effects associated with opioids.

What are the potential side effects?

While specific side effects of LDN in this context aren't detailed here, generally LDN can cause sleep disturbances, mild disorientation or confusion initially which usually resolve after initial use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been experiencing pain greater than 4 out of 10 for more than 3 months.

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My HIV viral load has been under 1000 copies/ml for the last 6 months.

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not breastfeeding and use effective birth control.

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I have been diagnosed with a liver disease, like cirrhosis.

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I am unable to give consent for medical procedures.

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I have bipolar disorder, schizophrenia, or my anxiety/depression is not well-managed.

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I do not have acute viral hepatitis A, B, or C.

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I have or might have long-term COVID symptoms.

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I have kidney disease or injury with a GFR less than 60.

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I have transportation problems that could prevent me from coming back for study visits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,11 and 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,11 and 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and study weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,11 and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in Numerical Pain Score

Secondary study objectives

Changes in Average pain Score

Changes in CD4 counts

Changes in IL-1 levels

+4 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Low Dose Naloxone (LDN)Experimental Treatment1 Intervention

Once a potential subject has been identified they may be contacted with information about the study in advance of their appointment in order to allow time for them to consider the study. A qualifying pain score will be confirmed with the subject prior to initiating consent. This may occur up to 30 days before the baseline, treatment visit, but inclusion/exclusion criteria will be re-confirmed prior to initiating study treatment. Patients may also be approached during a clinic visit. Subjects will be started with 3mg LDN orally administered daily for one week with a planned increase to 4 mg/day beginning week two, if tolerated. They will be provided a 4 week supply of study medication. LDN will be given as a daytime dose.

Group II: ControlActive Control1 Intervention

Once a potential subject has been identified they may be contacted with information about the study in advance of their appointment in order to allow time for them to consider the study. A qualifying pain score will be confirmed with the subject prior to initiating consent. This may occur up to 30 days before the baseline, treatment visit, but inclusion/exclusion criteria will be re-confirmed prior to initiating study treatment. Patients may also be approached during a clinic visit. Should a patient decline participation in the treatment plan, they will be invited to participate in a control group. They will be invited to complete the PROMIS questionnaire every 4 weeks, and the NPRS pain assessment every week from Baseline through week 12. These participants will receive follow up phone calls to confirm completion of these assessments weekly and will not have any in-person visits.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Low Dose Naltrexone

2007

N/A

~70

0 / 11Eligibility criteria met