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Opioid Antagonist

Low Dose Naltrexone for Neuropathic Pain

Phase 4
Waitlist Available
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
Be older than 18 years old
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

Study 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.

Eligible Conditions
  • Neuropathic Pain
  • HIV/AIDS

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Average pain Score
Changes in Numerical Pain Score
Pain
Secondary outcome measures
Changes in CRP Levels
Changes in DC4 counts
Changes in IL-1 levels
+6 more

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

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,513 Total Patients Enrolled
Anne M McKenzie-Brown, MDPrincipal InvestigatorEmory University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the primary aims of this clinical investigation?

"The overarching goal of this clinical study, assessed at Weeks 0, 4, 8 and 12 is to gauge fluctuations in average pain score. Secondary metrics involve analysing serum cytokines levels compared with baseline values as well as CD4 count variations over the same period and TNF-α level changes between initial visit and final visit. Blood will be collected by phlebotomy services according to institutional practices for all three objectives which shall then be sent to either Emory Medical Laboratory at EUH or ERHCCL (Emory Research Hemostasis & Coagulation Core Lab) respectively."

Answered by AI

Is this research venture accepting volunteers over the age of thirty-five?

"This study requires that participants be at least 18 years of age, but not older than 65. 202 trials are available to minors while 634 studies cater to adults over the retiree age."

Answered by AI

Who meets the criteria to partake in this clinical investigation?

"The requirements for entry are straightforward: individuals aged 18 to 65 who suffer from pain. Currently, there is an opening for around 60 participants in this experiment."

Answered by AI

Are there any unoccupied vacancies in this experiment available for potential participants?

"Clinicaltrials.gov reveals that, although first posted on November 1st 2022 and recently updated on September 9th 2022, this research trial is not currently seeking participants. However, 847 other medical studies are actively recruiting patients right now."

Answered by AI

Has the Federal Drug Administration given its stamp of approval to Low Dose Naltrexone?

"Our analysis at Power has rated Low Dose Naltrexone with a score of 3 since it is approved by the FDA, which signals that its safety profile has been extensively tested."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Low Dose Naltrexone for Pain in Patients With HIV
Anne Marie McKenzie-Brown 2023. "Low Dose Naltrexone for Pain in Patients With HIV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05537935.
~31 spots leftby Apr 2025
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