Human Immunodeficiency VirusPhase 4NCT05537935
Low Dose Naltrexone for Pain in Patients With HIV
A Phase 4 study testing Low Dose Naltrexone in people with Human Immunodeficiency Virus and Chronic Neuropathic Pain, run by Emory University at 3 sites in United States.
Trial summary
The increased life expectancy of Patients Living With HIV/AIDS (PLWHA) has increased the need for therapies for chronic conditions, such as chronic pain. Pain in the HIV population is often refractory and ends up being treated with chronic opioids, which are associated with adverse effects, including hyperalgesia… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Human Immunodeficiency Virus, Chronic Neuropathic Pain
- What is being tested?
- Low Dose Naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Apr 2023to 30 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75, male and female
- HIV infection with a viral load of < 1000 copies/ml for the past 12 months. (That is the viral load below which, according to the 2018 American College of Obstetricians and Gynecologists (ACOG) Committee Opinion, there is no thought of a significant risk of HIV transmission from the mother to the fetus with vaginal delivery. This was thought to be a reasonable cut-off for inclusion in this study.)
- Diagnosis of neuropathic pain (pain that is associated with a lesion or disease involving the somatosensory nervous system, e.g., painful neuropathy, radicular pain, complex regional pain syndrome, nerve-related pain following spine surgery, etc.) using the neuropathic pain screening tool, painDETECT17, as part of the neuropathic pain screen.
- Pain score > 4/10 on average on the NPRS lasting > 3 months (chronic pain)
- Capable of informed consent and willing to comply with the study requirements
- Fluent English-speaking
Who cannot join
- Allergy to naltrexone (not applicable to the control group)
- Current use of any opioids, up to 10 days before the start of the study (not applicable to the control group)
- Pregnant women
- Nursing mothers and women of childbearing potential not using contraception known to be highly effective (not applicable for the control group). Highly effective contraception methods include a combination of any two of the following during the 12-week study period:
- Use of oral, injected, or implanted hormonal methods of contraception or;
- Placement of an intrauterine device (IUD) or intrauterine system (IUS);
Show all 20Show fewer
- Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical /vault caps) with spermicidal foam/gel/film/cream/vaginal suppository;
- Total abstinence;
- Male/female sterilization.
- Bipolar disorder, schizophrenia, poorly controlled anxiety or depression
- Diagnosis of liver disease, e.g. cirrhosis
- Current diagnosis of either chronic kidney disease or acute kidney injury and/or a GFR <45 at baseline
- Acute viral hepatitis A, B, C
- Patients who self-report as having tested positive for COVID-19 or have been diagnosed with another viral illness within the past ten days.
- Patients with a known or suspected diagnosis of long-term COVID
- Active drug or alcohol use disorder
- People who may require opioid therapy during the duration of the study, e.g. upcoming surgery
- Transportation issues interfering with return study visits (NA for the control group)
- Adults unable to consent
- Prisoners
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Grady Memorial Hospital
Atlanta, Georgia, 30303
Brian Bobzien, MD, 404-616-5078, brian.patrick.bobzien@emory.edu
- Recruiting
Emory Midtown Hospital
Atlanta, Georgia, 30308
Kimberly A Workowski, MD, 404-686-7893, kworkow@emory.edu
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Anne M McKenzie-Brown, MD, 404-686-2410, amckenz@emory.edu
About this study
Official title: Low Dose Naltrexone (LDN) for the Treatment of Chronic Neuropathic Pain in Patients With Human Immunodeficiency Virus (HIV), a Prospective, Pragmatic, Open Label Clinical Trial
The increased life expectancy of Patients Living With HIV/AIDS (PLWHA) has increased the need for therapies for chronic conditions, such as chronic pain. Pain in the HIV population is often refractory and ends up being treated with chronic opioids, which are associated with adverse effects, including hyperalgesia, constipation, and risk of overdose. Naltrexone is an opioid antagonist used in the treatment of alcohol and opioid use disorders. Low 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. Repurposing this medication is relatively inexpensive and has the potential to expand access to treatment for a painful condition experienced in PLWHA. While there are many case reports on the efficacy of LDN in symptom reduction, there are only a small number of clinical trials that specifically examine pain and symptom relief.
This study will include patients who are not completely virologically controlled and will monitor the CD4 counts drawn as a part of routine care. If the CD4 count improves with LDN and with reduced symptoms, this could be a significant improvement in HIV therapy for symptom control. There have been studies showing cytokine reduction in fibromyalgia patients but they did not investigate the correlation with cytokines and pain relief. This study involves repurposing a drug used for substance use disorder to a medication with the potential to treat pain and improve symptoms for PLWHA.
Read the detailed description
More than one million people in the United States live with HIV. In 2018, Black/African Americans made up 42% of the new HIV diagnoses, while Hispanic persons accounted for 27%. Black/African Americans and Hispanics with an HIV diagnosis receive less care for treatment and maintenance of HIV than their Caucasian counterparts and are thus less likely to have adequate suppression of the virus. Many people living with HIV/AIDS have untreated chronic pain, which negatively affects their quality of life. Neuropathic (nerve) pain, including painful HIV neuropathy, is notoriously difficult to treat. Opioids (narcotics) are often used to treat chronic pain in patients, with inconsistent results. We now know that opioids for chronic pain are more consistently known for a multitude of side effects than effective long-term pain relief. Lesser-known side effects of chronic opioids include suppressing, or dampening, the immune system, making opioids particularly undesirable as a chronic therapy for pain in the HIV patient population. Other therapies for neuropathic pain have undesirable side effects. Naltrexone is FDA-approved for addiction and is not used to treat a medical disease. Low-dose naltrexone (LDN) is an off-label use of naltrexone with some evidence that it may help chronic pain, such as fibromyalgia and some types of neuropathic (nerve) pain. LDN is a much lower dose of naltrexone. It has to be compounded to 1/10 of the usual dose to be repurposed to treat pain. In 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 inflammation while they are taking LDN. Naltrexone repurposed as LDN has the potential to greatly enhance the quality of life of HIV patients. This is particularly meaningful given the healthcare disparities often associated with HIV.
- Being tested
- Low Dose Naltrexone
- Keywords
- Low dose Naltrexone, Naltrexone, Pain
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose NaltrexoneDrug
Also called Questionnaires
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 4-week supply of study medication. The most common side effects are difficulty sleeping and vivid dreams, which are seen more frequently with nighttime dosing, so LDN will be given as a daytime dose.
| Study group | Role | What they receive |
|---|---|---|
| Control | No 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 Naloxone (LDN) | Experimental | 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. Receives: Drug: Low Dose Naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Numerical Pain Score
The study team will give participants a link to the online PROMIS questionnaire that includes a numerical pain rating scale (NPRS) to complete using an iPad or computer and will verbally ask questions to establish baseline information required for the study. If they have no computer access, they will be given a hard copy of the PROMIS questionnaire and NPRS to complete for future visits.
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Changes in pain scores, measured on the numerical pain score (NPS) on the Pain Intensity section of the PROMIS-29 Profile v2.0. This will be measured weekly during the 12-week study period.
Measured: Study weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,11 and 12
Secondary outcomes (7)
Changes in PROMIS pain Score
The study team will give participants the PROMIS questionnaire to complete using an iPad or computer, or a paper form, and will verbally ask questions to establish baseline information required for the study. If they have no computer access, they will be given a hard copy of the PROMIS questionnaire to complete for future visits.
Changes in the overall score of the PROMIS-29 Profile v2.0 questionnaire collected at baseline, 4, 8, and 12 weeks will be assessed.
The participants' answers to PROMIS-29 are scored from 1-5. The sum of the PROMIS results in the raw score, which lies between 4 and 20. There is no total score, but each axis forms its own score. PROMIS assessments use an Item Response Theory (IRT) based score called "Expected A Posteriori" or EAP scores, which are then transformed onto a final T-score metric. The scores are mapped so that the values follow a normal distribution with a population mean T-score of 50 and a standard deviation of 10.
Measured: Study weeks 0, week 4, week 8 and week 12
Changes in Average pain Score
The study team will give participants a link to the online PROMIS questionnaire that includes a numerical pain rating scale (NPRS) to complete using an iPad or computer and will verbally ask questions to establish baseline information required for the study. If they have no computer access, they will be given a hard copy of the PROMIS questionnaire and NPRS to complete for future visits.
The study team will compare the average weekly pain scores of the study group with the control group.
Measured: Study weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,11 and 12
Changes in IL-1 levels
Blood will be drawn by phlebotomy services according to institutional practice. Samples for will be sent to the Emory Medical Laboratory at EUH or Emory University Hospital Midtown (EUHM) for processing and analysis.
Serum cytokines values will be measured at the 12-week visit and will be compared to baseline visit values.
Measured: Study week 0 and week 12
Changes in IL-18 levels
Blood will be drawn by phlebotomy services according to institutional practice. Samples for will be sent to the Emory Medical Laboratory at EUH or Emory University Hospital Midtown (EUHM) for processing and analysis.
Serum cytokines values will be measured at the 12-week visit and will be compared to baseline visit values.
Measured: Study week 0 and week 12
Changes in Met-Enkephalin Levels
Blood will be drawn and collected by phlebotomy services according to institutional practices into 2 purple top tubes (EDTA, 10 ml) at the baseline and 12-week visits. These samples will be sent to the Emory Research Hemostasis and Coagulation Core Laboratory (ERHCCL) Changes in Met-Enkephalin levels at the 12-week visit compared to baseline visit levels.
Measured: Study week 0 and week 12
Changes in endorphin levels
Blood will be drawn and collected by phlebotomy services according to institutional practices into 2 purple top tubes (EDTA, 10 ml) at the baseline and 12-week visits. These samples will be sent to the Emory Research Hemostasis and Coagulation Core Laboratory (ERHCCL) Changes in endorphin levels at the 12-week visit compared to baseline visit levels.
Measured: Study week 0 and week 12
Changes in CD4 counts
Blood will be drawn and collected by phlebotomy services according to institutional practices into 2 purple top tubes (EDTA, 10 ml) at the baseline and 12-week visits. These samples will be sent to the Emory Research Hemostasis and Coagulation Core Laboratory (ERHCCL) Changes in CD4 counts levels at the 12-week visit compared to baseline visit levels.
Measured: Study week 0 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start28 Apr 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Marie McKenzie-Brown, Emory University
- Investigators
- Anne M McKenzie-Brown, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537935
- Sponsor's protocol ID
- STUDY00004422
- Other IDs
- 2025P011310
- Status last verified
- Mar 2026
- First submitted
- 9 Sep 2022
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, appendices)
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Naltrexone (LDN) for the Treatment of Chronic Neuropathic Pain in Patients With Human Immunodeficiency Virus (HIV), a Prospective, Pragmatic, Open Label Clinical Trial
- ClinicalTrials.gov ID
- NCT05537935
- Acronym / sponsor ID
- STUDY00004422
- Keywords
- Low dose Naltrexone, Naltrexone, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Sep 2022 (actual)
- 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 increased life expectancy of Patients Living With HIV/AIDS (PLWHA) has increased the need for therapies for chronic conditions, such as chronic pain. Pain in the HIV population is often refractory and ends up being treated with chronic opioids, which are associated with adverse effects, including hyperalgesia, constipation, and risk of overdose. Naltrexone is an opioid antagonist used in the treatment of alcohol and opioid use disorders. Low 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. Repurposing this medication is relatively inexpensive and has the potential to expand access to treatment for a painful condition experienced in PLWHA. While there are many case reports on the efficacy of LDN in symptom reduction, there are only a small number of clinical trials that specifically examine pain and symptom relief.
This study will include patients who are not completely virologically controlled and will monitor the CD4 counts drawn as a part of routine care. If the CD4 count improves with LDN and with reduced symptoms, this could be a significant improvement in HIV therapy for symptom control. There have been studies showing cytokine reduction in fibromyalgia patients but they did not investigate the correlation with cytokines and pain relief. This study involves repurposing a drug used for substance use disorder to a medication with the potential to treat pain and improve symptoms for PLWHA.
Detailed description
More than one million people in the United States live with HIV. In 2018, Black/African Americans made up 42% of the new HIV diagnoses, while Hispanic persons accounted for 27%. Black/African Americans and Hispanics with an HIV diagnosis receive less care for treatment and maintenance of HIV than their Caucasian counterparts and are thus less likely to have adequate suppression of the virus. Many people living with HIV/AIDS have untreated chronic pain, which negatively affects their quality of life. Neuropathic (nerve) pain, including painful HIV neuropathy, is notoriously difficult to treat. Opioids (narcotics) are often used to treat chronic pain in patients, with inconsistent results. We now know that opioids for chronic pain are more consistently known for a multitude of side effects than effective long-term pain relief. Lesser-known side effects of chronic opioids include suppressing, or dampening, the immune system, making opioids particularly undesirable as a chronic therapy for pain in the HIV patient population. Other therapies for neuropathic pain have undesirable side effects. Naltrexone is FDA-approved for addiction and is not used to treat a medical disease. Low-dose naltrexone (LDN) is an off-label use of naltrexone with some evidence that it may help chronic pain, such as fibromyalgia and some types of neuropathic (nerve) pain. LDN is a much lower dose of naltrexone. It has to be compounded to 1/10 of the usual dose to be repurposed to treat pain. In 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 inflammation while they are taking LDN. Naltrexone repurposed as LDN has the potential to greatly enhance the quality of life of HIV patients. This is particularly meaningful given the healthcare disparities often associated with HIV.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No 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 Naloxone (LDN) | Experimental | Drug: Low Dose NaltrexoneOnce 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-75, male and female
- HIV infection with a viral load of < 1000 copies/ml for the past 12 months. (That is the viral load below which, according to the 2018 American College of Obstetricians and Gynecologists (ACOG) Committee Opinion, there is no thought of a significant risk of HIV transmission from the mother to the fetus with vaginal delivery. This was thought to be a reasonable cut-off for inclusion in this study.)
- Diagnosis of neuropathic pain (pain that is associated with a lesion or disease involving the somatosensory nervous system, e.g., painful neuropathy, radicular pain, complex regional pain syndrome, nerve-related pain following spine surgery, etc.) using the neuropathic pain screening tool, painDETECT17, as part of the neuropathic pain screen.
- Pain score > 4/10 on average on the NPRS lasting > 3 months (chronic pain)
- Capable of informed consent and willing to comply with the study requirements
Key exclusion criteria (20 listed)
- Allergy to naltrexone (not applicable to the control group)
- Current use of any opioids, up to 10 days before the start of the study (not applicable to the control group)
- Pregnant women
- Nursing mothers and women of childbearing potential not using contraception known to be highly effective (not applicable for the control group). Highly effective contraception methods include a combination of any two of the following during the 12-week study period:
- Bipolar disorder, schizophrenia, poorly controlled anxiety or depression
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 |
|---|---|---|
| Low Dose NaltrexoneAlso: QuestionnairesParticipants 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 4-week supply of study medication. The most common side effects are difficulty sleeping and vivid dreams, which are seen more frequently with nighttime dosing, so LDN will be given as a daytime dose. | Drug | Low Dose Naloxone (LDN) |
Primary outcome
Changes in Numerical Pain Score
Time frame: Study weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,11 and 12
The study team will give participants a link to the online PROMIS questionnaire that includes a numerical pain rating scale (NPRS) to complete using an iPad or computer and will verbally ask questions to establish baseline information required for the study. If they have no computer access, they will be given a hard copy of the PROMIS questionnaire and NPRS to complete for future visits. The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). Changes in pain scores, measured on the numerical pain score (NPS) on the Pain Intensity section of the PROMIS-29 Profile v2.0. This will be measured weekly during the 12-week study period.
7 secondary outcomes
Changes in PROMIS pain Score
Time frame: Study weeks 0, week 4, week 8 and week 12
Changes in Average pain Score
Time frame: Study weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,11 and 12
Changes in IL-1 levels
Time frame: Study week 0 and week 12
Changes in IL-18 levels
Time frame: Study week 0 and week 12
Changes in Met-Enkephalin Levels
Time frame: Study week 0 and week 12
Changes in endorphin levels
Time frame: Study week 0 and week 12
Changes in CD4 counts
Time frame: Study week 0 and week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, appendices)
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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.
Anne M McKenzie-Brown, MD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low Dose Naltrexone in people with Human Immunodeficiency Virus and Chronic Neuropathic Pain, run by Emory University 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 6 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 9 Apr 2026. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne M McKenzie-Brown, MD (404-686-2410, amckenz@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Numerical Pain Score (time frame: Study weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,11 and 12). 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 Apr 2026.