# Opioid therapy for pain in individuals with metastatic cancer: benefits, harms and stakeholder perspectives

> **NIH NIH R01** · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2021 · $739,175

## Abstract

Project Summary
Opioid therapy for pain in patients with metastatic cancer is a critical yet understudied area. Pain is
experienced at some point by most patients with metastatic cancer. Prescribed opioids are a cornerstone of
treating pain; the prevalent belief in the field has been that the benefits of palliating pain in metastatic cancer
with opioids nearly always outweigh any potential harms. This approach to opioid-related decisions in patients
with metastatic cancer implies that patients’ prognoses are either so short that these harms are not
meaningful, or that benefits of opioids are substantial while harms are relatively minimal. Research on the
benefits and harms of opioid therapy has exploded in the past decade but primarily focuses on individuals with
chronic “non-cancer” pain. However, patients with cancer have been routinely excluded from these studies and
resulting recommendations that favor more conservative opioid prescribing. The few studies of patients with
cancer generally support that serious harms occur, but have significant methodologic limitations. Additionally,
there are unique considerations in individuals with metastatic cancer, including life-limiting disease that may
last years, high pain rates, and opioids as accepted standard of care. Therefore, assessing benefits and risk
factors for opioid-related harms in individuals with metastatic cancer is a critical gap in the literature and key to
opioid-related decision-making. The long-term goal of this program of research is to develop interventions that
inform opioid-related decision-making for patients with metastatic cancer. We will use the Behavioral Decision
Research framework to create a comprehensive evidence base on which these interventions can be grounded,
which is the objective of the present application. To accomplish our aims, we have partnered with the NINR-
funded Palliative Care Research Cooperative to develop a prospective cohort of patients newly diagnosed with
metastatic cancer. We propose the following Aims in patients with metastatic cancer: Aim 1: Investigate the
relationship between opioid therapy and opioid-related benefits. Hypothesis 1: Opioid therapy will be
associated with decreased pain severity and pain interference (co-primary outcomes). Aim 2: Investigate risk
factors for opioid-related harms. Hypothesis 2a: Certain co-prescribed medications will be associated with
increased risk of opioid side effects (e.g., benzodiazepines and somnolence). Hypothesis 2b: Younger age,
history of substance use disorder, and history of mood disorders will be associated with greater risk of opioid
misuse and use disorder. Approach: We will use linear mixed effects models (2a) and time-to-event analyses
(2b). Aim 3: Understand stakeholder (patient, family caregiver, clinician) perspectives on opioid-related
decision-making. Completion of these aims will lead directly to an R-series proposal to develop and test a
novel intervention to inform opioid decision-mak...

## Key facts

- **NIH application ID:** 10280057
- **Project number:** 1R01NR020031-01
- **Recipient organization:** UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- **Principal Investigator:** Jessica S Merlin
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $739,175
- **Award type:** 1
- **Project period:** 2021-09-15 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10280057

## Citation

> US National Institutes of Health, RePORTER application 10280057, Opioid therapy for pain in individuals with metastatic cancer: benefits, harms and stakeholder perspectives (1R01NR020031-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10280057. Licensed CC0.

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