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Evaluating the feasibility and acceptability of expectation-optimized open-label placebo as an adjuvant treatment for chronic pain

Award Number: R34AT013235
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: 09/10/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2029

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Evaluating the feasibility and acceptability of expectation-optimized open-label placebo as an adjuvant treatment for chronic pain - Chronic pain is prevalent and is a major clinical, social, and economic problem. The incidence rate of chronic pain increased to 46% based on a national survey in the US that was conducted in 2020. The direct cost to the healthcare system is estimated to be high as $261 to 300 billion. Despite the high prevalence and high cost, an optimal treatment is not yet found to cure or manage chronic pain. Traditional pharmacological treatments for chronic pain such as the use of non-steroidal anti-inflammatory drugs (NSAIDs) has been shown to have moderate effect sizes and medications such as opioids have suffered from easily developed high drug tolerance, side effects, and potential problems of addiction. Therefore, the NIH has proposed non-pharmacological treatment as the first option for chronic pain treatment. This project aims to adapt a promising adjuvant treatment open-label placebo (OLP) with optimizing expectation management in a cohort of chronic orofacial pain. OLP are placebos that are given transparently without deception. We and others have shown certain efficacy of OLP in mitigating chronic pain in participants with chronic temporomandibular disorders, lower back pain, and osteoarthritis. However, the effect size of the OLP efficacy in randomized clinical trials has been heterogenous, ranging from small to medium, preventing its reliable and robust use as an adjuvant treatment for chronic pain. Notably, empirical evidence has shown that positive treatment expectations are critical in driving the OLP induced analgesic effects. However, the current OLP instruction lack a procedure specifically targets expectations. Moreover, the negative lay perception about OLP prevent it from being actively included in participants’ daily medication regimen. Recently, a novel expectation optimization psychotherapy EXPECT has been developed to boost the expectations in patients undergoing cardiac surgeries and has shown to be efficacious in improving post-surgical pain disability and reducing side effects. This R34 proposes to adapt the original EXPECT therapy to shape the expectations towards OLP (OLP-EXP) and general chronic pain management (EXP only). We will follow the ADAPT guidelines to OLP-EXP and EXP only. In AIM 1, we will adapt the EXPECT content to meet the needs of chronic pain participants, while maintaining the key features of the original EXPECT. AIM 2 will be a feasibility randomized control trial to collect information on retention rate, and adherence rate to OLP-EXP and EXP only in comparison with OLP only. A semi-structured interview will be conducted at the end to understand participants’ attitudes towards the OLP- EXP, EXP only, and OLP only interventions. Overall, assessing feasibility and acceptability of the OLP-EXP and EXP only provide guidance for preparing subsequent larger scale rigorous efficacy and effectiveness studies. After the completion of this trial, we aim to conduct a subsequent clinical efficacy trial under the NCCIH’s mission.


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 = $692,332 )
2026	2026	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Research and Training in Complementary and Integrative Health	000	1	9/9/2026	NEW	$692,332
														Subtotal = $692,332

Grand Total All Awards = $692,332

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Evaluating the feasibility and acceptability of expectation-optimized open-label placebo as an adjuvant treatment for chronic pain

Award Number: R34AT013235

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: 09/10/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2029

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