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

Award Number: R34AT012677
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/26/2024
PERIOD OF PERFORMANCE END DATE: 03/31/2027

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Investigating the Feasibility of Combining Mindfulness Intervention and Open-Label Placebo Treatment for Chronic Pain - 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 MBSR and OLP treatment in a future fully-powered multi-site clinical trial.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $235,500 )
2026	2026	ARIZONA STATE UNIVERSITY	1475 N SCOTTSDALE RD STE 200	SCOTTSDALE	AZ	85257	MARICOPA	USA	Research and Training in Complementary and Integrative Health	000	3	3/20/2026	NON-COMPETING CONTINUATION	$235,500
														Subtotal = $235,500

Issue Date FY: 2025 ( Subtotal = $211,950 )
2025	2025	ARIZONA STATE UNIVERSITY	660 S MILL AVENUE STE 204	TEMPE	AZ	85281	MARICOPA	USA	Research and Training in Complementary and Integrative Health	000	2	3/13/2025	NON-COMPETING CONTINUATION	$211,950
2025	2025	ARIZONA STATE UNIVERSITY	660 S MILL AVENUE STE 204	TEMPE	AZ	85281	MARICOPA	USA	Research and Training in Complementary and Integrative Health	001	2	6/24/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $211,950

Issue Date FY: 2024 ( Subtotal = $235,500 )
2024	2024	ARIZONA STATE UNIVERSITY	660 S MILL AVENUE STE 204	TEMPE	AZ	85281	MARICOPA	USA	Research and Training in Complementary and Integrative Health	000	1	7/26/2024	NEW	$235,500
														Subtotal = $235,500

Grand Total All Awards = $682,950

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

Award Number: R34AT012677

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/26/2024

PERIOD OF PERFORMANCE END DATE: 03/31/2027

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