Apply to Trial

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

60 Participants Needed

Low Dose Naltrexone for Pain in HIV/AIDS

Recruiting at 2 trial locations

Overseen ByAnne M McKenzie-Brown, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Emory University

Must not be taking: Opioids

Disqualifiers: Pregnancy, Bipolar, Liver disease, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Low Dose Naltrexone (LDN) to determine its effectiveness in reducing pain for people living with HIV/AIDS. Chronic pain is common in this group, and current treatments often rely on opioids, which have many side effects. Although typically used for substance use disorders, LDN might also boost the immune system and alleviate pain. Individuals with HIV who have experienced ongoing pain for more than three months and maintain a viral load under a certain level may qualify for this study. The trial aims to find a safer, more effective method to manage chronic pain in people with HIV/AIDS. As a Phase 4 trial, it involves an FDA-approved treatment and seeks to understand how it can benefit more patients.

Will I have to stop taking my current medications?

The trial requires that you stop using any opioids at least 10 days before starting the study. Other medications are not specifically mentioned, so it's best to discuss your current medications with the study team.

What is the safety track record for Low Dose Naltrexone?

Research shows that Low Dose Naltrexone (LDN) is generally safe. Earlier studies reported mild side effects in some participants, such as fatigue, sleep disturbances, or stomach issues like diarrhea or nausea. These side effects were usually not serious.

LDN is a smaller dose of naltrexone, a medication typically used to help people with alcohol or opioid addictions stay off these substances. At lower doses, LDN may support the immune system. For those considering joining a clinical trial, it's important to know that LDN is not yet officially approved for any condition. However, research has explored its potential to help with chronic pain and to strengthen the immune system in people with HIV/AIDS.¹ ² ³ ⁴ ⁵

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for pain in HIV/AIDS, which often include opioids or non-steroidal anti-inflammatory drugs (NSAIDs), Low Dose Naltrexone (LDN) offers a unique approach. LDN is exciting because it works by modulating the immune system and reducing inflammation, which may help manage pain with fewer side effects compared to traditional painkillers. Additionally, LDN is taken in small oral doses, potentially improving patient adherence and minimizing the risk of dependency associated with higher-dose opioids. Researchers are enthusiastic about LDN's potential to provide effective pain relief with a lower risk of addiction and side effects.

What evidence suggests that Low Dose Naltrexone might be an effective treatment for pain in HIV/AIDS?

Research has shown that low-dose naltrexone (LDN) can reduce pain in conditions such as fibromyalgia, Crohn's disease, and multiple sclerosis. Studies have found that LDN effectively manages pain, with some patients experiencing significant relief. In this trial, participants will receive LDN to evaluate its effectiveness in managing chronic pain in patients with HIV/AIDS. Additionally, LDN has been linked to higher CD4 counts in people with HIV/AIDS, potentially improving their overall health. This suggests that LDN could be a promising option for these patients. The treatment is generally well-tolerated and might offer a safer alternative to traditional pain medications like opioids.¹ ⁶ ⁷ ⁸ ⁹

Who Is on the Research Team?

Anne M McKenzie-Brown, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Fluent English-speaking

Diagnosis of neuropathic pain using the neuropathic pain screening tool, painDETECT17

See 2 more

Exclusion Criteria

Prisoners

I am not breastfeeding and use effective birth control.

Allergy to naltrexone

See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive low-dose naltrexone (LDN) for 12 weeks to treat neuropathic pain

12 weeks

Weekly assessments (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

Low Dose Naltrexone

Trial Overview 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.

How Is the Trial Designed?

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. Participants will start 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 with a four-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.

Low Dose Naltrexone is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Revia for:

Alcohol use disorder
Opioid use disorder

Approved in European Union as Vivitrol for:

Alcohol dependence
Opioid dependence

Approved in Canada as Naltrexone Hydrochloride for:

Alcohol dependence
Opioid dependence

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

In a 48-week study involving 200 participants with opioid addiction and HIV, the naltrexone implant group showed a significant improvement in maintaining viral loads below 400 copies per mL at 48 weeks compared to the oral naltrexone group, suggesting that long-acting naltrexone may enhance HIV treatment outcomes.

Despite some serious adverse events, including deaths in both groups, the study indicates that longer opioid blockade from the implant may help protect against missed antiretroviral therapy doses and impulsive behaviors that could lead to relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Slow-release naltrexone implant versus oral naltrexone for improving treatment outcomes in people with HIV who are addicted to opioids: a double-blind, placebo-controlled, randomised trial.Krupitsky, E., Blokhina, E., Zvartau, E., et al.[2020]

Following a 2013 TV documentary, the use of low dose naltrexone (LDN) in Norway surged, with 15,297 patients (0.3% of the population) receiving prescriptions, indicating a significant increase in off-label use despite limited evidence.

The median daily dose of LDN was 3.7 mg, and a notable 20% of doctors, including 71% of general practitioners, prescribed LDN at least once, reflecting a high willingness to adopt this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A sudden and unprecedented increase in low dose naltrexone (LDN) prescribing in Norway. Patient and prescriber characteristics, and dispense patterns. A drug utilization cohort study.Raknes, G., Småbrekke, L.[2022]

Low-dose naltrexone, ranging from 1 mg to 4.5 mg, is a promising nonopioid alternative for managing chronic pain, autoimmune disorders, and dermatologic conditions, despite being used off-label.

It offers a safer profile compared to traditional pain medications, as it has minimal adverse effects, no significant drug-drug interactions, and is more cost-effective, reducing risks associated with other pain management options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Low-Dose Naltrexone for Chronic Pain.Bostick, KM., McCarter, AG., Nykamp, D.[2019]

Citations

1.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC3962576/

The use of low-dose naltrexone (LDN) as a novel anti ...Low-dose naltrexone (LDN) has been demonstrated to reduce symptom severity in conditions such as fibromyalgia, Crohn's disease, multiple sclerosis, and complex ...

2.clinicaltrials.govclinicaltrials.gov/study/NCT05537935?term=AREA%5BBasicSearch%5D(low%20dose%20naltrexone)&rank=9

Low Dose Naltrexone for Pain in Patients With HIVIn this study, 40 adult patients with HIV will take low-dose naltrexone for 12 weeks to treat neuropathic pain. We will measure pain scores and markers of ...

3.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC10964028/

Effective Doses of Low-Dose Naltrexone for Chronic PainConclusions. LDN with idiosyncratic dosing appears to effectively suppress chronic pain. LDN may be a useful medication for patients with pain ...

4.centerwatch.comcenterwatch.com/clinical-trials/listings/NCT05537935/low-dose-naltrexone-for-pain-in-patients-with-hiv

Low Dose Naltrexone for Pain in Patients With HIVIn this study, 40 adult patients with HIV will take low-dose naltrexone for 12 weeks to treat neuropathic pain. We will measure pain scores and ...

5.trial.medpath.comtrial.medpath.com/clinical-trial/3c9202e0a9012728/low-dose-naltrexone-chronic-neuropathic-pain-hiv

Low Dose Naltrexone for Pain in Patients With HIV | MedPathIn this study, 40 adult patients with HIV will take low-dose naltrexone for 12 weeks to treat neuropathic pain. We will measure pain scores and markers of ...

6.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC10276990/

Low-Dose Naltrexone (LDN) for Chronic Pain at a Single ...Of the n = 137 patients who were prescribed LDN, 44% had no evidence of ever filling the prescription, and 4.4% of the responses were not ...

7.mayoclinic.orgmayoclinic.org/drugs-supplements/naltrexone-oral-route/description/drg-20068408

Naltrexone (oral route) - Side effects & dosageNaltrexone is used to help patient with opioid use disorder who have stopped taking opioids to stay drug-free and maintain their recovery.

8.clinicaltrials.govclinicaltrials.gov/study/NCT05537935

Low Dose Naltrexone for Pain in Patients With HIVLow Dose Naltrexone (LDN), naltrexone at a much lower dose, is thought to be an immune modulator and has been associated with an increased CD4 count in PLWHA.

9.dvcstem.comdvcstem.com/post/side-effects-of-low-dose-naltrexone

Side Effects of Low Dose Naltrexone: What You Should ...The ldn side effects can vary but generally include symptoms like fatigue, sleep disturbances, and gastrointestinal issues like diarrhea or nausea.

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Low Dose Naltrexone for Pain in HIV/AIDS

What You Need to Know Before You Apply

Who Is on the Research Team?

Are You a Good Fit for This Trial?

Timeline for a Trial Participant

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

Published Research Related to This Trial

Citations

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