# Investigating the Feasibility of Combining Mindfulness Intervention and Open-Label Placebo Treatment for Chronic Pain

> **NIH NIH R34** · ARIZONA STATE UNIVERSITY-TEMPE CAMPUS · 2024 · $235,500

## Abstract

PROJECT SUMMARY: Chronic pain affects over one third of the U.S. population and is a leading cause of
disability. Hence, there is pressing need for developing innovative, safe, and accessible non-opioid treatments
that effectively alleviate chronic pain. Mindfulness-based therapies (MBTs) have emerged as widely used
mind-body interventions for chronic pain, focusing on enhancing present-moment attention, non-judgmental
awareness, and acceptance. Despite their popularity, the overall effects of MBTs on pain-related outcomes
remain modest. Recent mechanistic studies have shed light on the fact that mindfulness meditation does not
modulate the endogenous opioid system, a crucial player in pain relief. This revelation underscores the
potential for improving the efficacy of an MBT by integrating it with a safe, non-opioid intervention capable of
directly modulating endogenous opioid system. Open-label placebo (OLP), a non-deceptive placebo, presents
a promising, safe, and ethical intervention for chronic pain that can be combined with an MBT. Research has
indicated that placebo-induced analgesia is mediated by the release of endogenous opioids. Consequently,
there is a strong rationale to hypothesize that the combined application of an MBT and OLP treatment may
yield more potent and enduring effects in alleviating chronic pain than either treatment used in isolation. This
R34 study proposes a single-site three-arm randomized-controlled trial to evaluate the feasibility and
acceptability of combining Mindfulness-Based Stress Reduction (MBSR), one of the most established and
extensively studied MBTs for chronic pain, with OLP treatment for individuals living with chronic pain. A total of
45 participants will be randomly assigned to one of the following three conditions for an 8-week trial with a 3-
month follow-up period: (1) MBSR-only; (2) OLP-only; and (3) a combination of MBSR and OLP treatment. The
feasibility of conducting the proposed trial will be determined by several metrics, including: (1) the rate of
participant enrollment, (2) participant retention from baseline to 3-month post-treatment follow-up, (3)
adherence to the MBSR program, (3) adherence to OLP treatment monitored using a smart pillbox and the
detection of urinary riboflavin tracer in mid- and post-treatment sessions; and (5) compliance with daily diary
assessments. The acceptability of combining MBSR and OLP treatment will be determined by self-report
ratings regrading (1) treatment satisfaction, (2) intervention effectiveness, (3) intervention convenience, (4)
side effects, (5) appropriateness of intervention and daily diary assessment length and frequency; and (6)
appropriateness of other study measures. The ultimate goal of this study is to advance chronic pain
management strategies for millions of individuals with chronic pain. The proposed study will serve as a pivotal
initial step in establishing procedures and strategies necessary for a comprehensive evaluation of combined
M...

## Key facts

- **NIH application ID:** 10951436
- **Project number:** 1R34AT012677-01A1
- **Recipient organization:** ARIZONA STATE UNIVERSITY-TEMPE CAMPUS
- **Principal Investigator:** Chung Jung Mun
- **Activity code:** R34 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $235,500
- **Award type:** 1
- **Project period:** 2024-07-26 → 2027-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10951436

## Citation

> US National Institutes of Health, RePORTER application 10951436, Investigating the Feasibility of Combining Mindfulness Intervention and Open-Label Placebo Treatment for Chronic Pain (1R34AT012677-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10951436. Licensed CC0.

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