# Optimizing open placebos for chronic pain patients

> **NIH NIH P20** · RHODE ISLAND HOSPITAL · 2024 · $264,438

## Abstract

PROJECT SUMMARY
 The United States is in the midst of a serious opioid epidemic, with 107,622 drug overdose causalities
in 2021. An astounding 1 in 5 Americans have chronic pain, and prescription opioid medication for chronic pain
treatment has more than tripled between 1999 and 2015. Research is needed to develop and test safe
alternatives to opioids for the treatment of chronic pain. The purpose of this project is to examine one such
option: open-label (i.e. honest) placebos (OLPs). While placebos are typically used in control conditions to test
against active treatment, research across a variety of clinical trials has shown that placebos, even when given
without deception or concealment, can effectively treat chronic pain. Typically, participants enrolled in OLP
trials receive a that explains why placebos are effective; the rationales are based on a 15-minute 4-
point discussion between the researcher/provider and participant. However, no research has systematically
examined what types of rationales for OLPs promote the most symptom relief. An optimized open-label
placebo rationale for chronic pain has the potential to greatly improve OLP efficacy. Participants (n=340 at
baseline) in the proposed project will be patients with chronic pain who use opioids. They will be assigned to
one of four conditions: an evidence-based rationale condition, where the placebo rationale is adapted
heavily from prior OLP studies, b) a mindfulness rationale condition, where participants are asked to accept
any unpleasant sensations and visualize the placebo pill washing away pain, c) a no rationale control
condition, where participants receive OLPs in the absence of a rationale, and d) a no treatment control
condition where participants do not receive a placebo. Participants in conditions a-c will be asked to take 2
placebos per day, honestly described as placebos, for 21 days. All participants will be assessed at baseline,
mid-point (11 days after OLP use), and two-follow-up periods (at the very end of OLP use and 28 days after
the end of OLP use). All assessments and rationales will occur remotely through teleconferencing, and all
placebos will be distributed by mail. Study outcomes are opioid use and pain.

## Key facts

- **NIH application ID:** 10923925
- **Project number:** 5P20GM125507-07
- **Recipient organization:** RHODE ISLAND HOSPITAL
- **Principal Investigator:** Michael Harrison Bernstein
- **Activity code:** P20 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $264,438
- **Award type:** 5
- **Project period:** 2018-09-01 → 2028-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10923925

## Citation

> US National Institutes of Health, RePORTER application 10923925, Optimizing open placebos for chronic pain patients (5P20GM125507-07). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10923925. Licensed CC0.

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