# Pilot Study of Opioid-receptor Antagonists to Reduce Pain and Inflammation among HIV-Infected Persons with Alcohol Problems

> **NIH NIH UH3** · BOSTON MEDICAL CENTER · 2020 · $354,565

## Abstract

Pain is a common co-morbidity for HIV-infected patients. Prevalence studies suggest that, on average, half of
all HIV-infected persons suffer pain. Chronic pain can lead to heavy alcohol use among HIV-infected persons,
which may in turn be a barrier to treatment/control of HIV and contribute to spread of HIV. Thus there is an
urgent need to address pain among persons with HIV. Opioid receptor antagonists such as naltrexone and
nalmefene, which are licensed for treatment of alcohol use disorders, show promise as being effective and
safe treatments for chronic pain among persons with HIV. This study will pilot test novel pharmacotherapies
(opioid receptor antagonists) to improve chronic pain among HIV-infected heavy drinkers, and will explore the
hypothesis that the mechanism of action for improving pain is through decreased inflammation. The specific
aims of the research are: UH2/Aim 1: To assess the feasibility, tolerability and safety of using opioid receptor
antagonists (low-dose naltrexone and nalmefene) to treat pain among HIV-infected persons with heavy alcohol
use and chronic pain; UH3/Aim 2: to perform a 3-arm pilot randomized, double-blinded, placebo-controlled
study of low-dose naltrexone and nalmefene vs. placebo among HIV-infected persons with heavy alcohol use
and chronic pain to provide estimates of their effects on: 1) pain (both self-reported and experimental/cold
pressor test; 2) inflammation (i.e., levels of inflammatory cytokines IL-6 and TNF-α); and 3) measures of HIV
control (CD4 count and viral load). The results of this study will provide preliminary information (tolerability,
effect size, etc.) to design a larger RCT of low-dose naltrexone and/or nalmefene for chronic pain among
persons with heavy alcohol use. We choose to conduct this research in St. Petersburg, Russia, given that: 1)
nalmefene is licensed in Russia, but not currently in the US; 2) patients are seldom on chronic opioids (which
are contraindicated to use with opioid receptor antagonists) due to the unavailability of opioid agonist therapy
for addiction and restricted use of opioids for pain; and 3) a high prevalence of heavy drinking and HIV exists in
Russia. Addressing chronic pain is a high priority for patients with HIV, and therefore this application is highly
“patient-centered” as well as innovative. Given the US epidemic of opioid use disorders, new
pharmacotherapies without addictive potential are desperately needed for HIV-infected persons with chronic
pain and alcohol problems.

## Key facts

- **NIH application ID:** 10019309
- **Project number:** 5UH3AA026193-04
- **Recipient organization:** BOSTON MEDICAL CENTER
- **Principal Investigator:** JEFFREY H. SAMET
- **Activity code:** UH3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $354,565
- **Award type:** 5
- **Project period:** 2019-09-20 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10019309

## Citation

> US National Institutes of Health, RePORTER application 10019309, Pilot Study of Opioid-receptor Antagonists to Reduce Pain and Inflammation among HIV-Infected Persons with Alcohol Problems (5UH3AA026193-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10019309. Licensed CC0.

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