# Improving Sleep and Reducing Opioid Use in Individuals with Chronic Pain

> **NIH NIH R01** · UNIVERSITY OF SOUTH FLORIDA · 2023 · $664,119

## Abstract

PROJECT SUMMARY
Opioid therapy is commonly prescribed for patients with chronic widespread musculoskeletal pain, but offers questionable
benefit for long-term pain management and is associated with arrhythmias, overdose, and death. Individuals with chronic
pain experience high rates of comorbid chronic insomnia, arousal, and abnormal brain activation in response to painful
stimuli. Research shows individuals with chronic pain exhibit increased brain activation in regions associated with pain
modulation in response to painful stimuli compared to healthy controls. Withdrawal from opioids is difficult; and
inadequately managed pain contributes to that difficulty. The Cognitive Activation Theory of Stress (CATS) tests the
hypothesis that poor sleep and arousal lead to critical changes in brain activation that increase pain severity and lead to
opioid use. Research shows cognitive behavioral treatment for insomnia (CBT-I, an evidence based intervention for chronic
insomnia) improves sleep, arousal, abnormal brain activation, and pain in individuals with comorbid chronic pain and
insomnia, but does not reduce opioid use. However, because CBT-I improves each of the mediators hypothesized to
contribute to opioid use, it warrants examination as a neoadjuvant to gradual tapering of opioid medication. The proposed
trial tests the novel hypothesis that improving sleep and decreasing arousal will lead to normalized brain activation and
decreased pain prior to gradual tapering, which will facilitate reduced opioid use. This hypothesis is supported by theory
(CATS) and empirical findings. It also reflects federal pain research priorities.
Trial Design. 165 adults who use prescription opioid users (18+ years of age) and have chronic pain and insomnia will be
randomized to CBT-I or Sleep Hygiene and Related Education (SHARE). They will then undergo a gradual tapered
withdrawal protocol for opioids. Outcomes (sleep, arousal, brain activation, pain, opioid use, opioid related problems) will
be examined at baseline (BL), post intervention (P1), post withdrawal (P2), and 6-month follow-up. Specific Aims 1 and 2
test the impact of CBT-I on sleep, arousal, brain activation, pain, opioid use, and opioid related problems compared to the
active SHARE control. Specific Aims 3 and 4 test the impact of tapering opioid use following CBT-I on sleep, arousal,
brain activation, pain, opioid use, and opioid related problems compared to the combined SHARE and tapered withdrawal
control. An Exploratory Aim examines the relationships between changes in the mechanistic outcomes and changes in the
opioid outcomes, and their potential moderators (e.g., craving, withdrawal symptoms, sex, age, race, ethnicity).
Public Health Implications: Demonstration that a relatively brief behavioral sleep intervention facilitates tapered
withdrawal from opioid medication and protects against relapse through improvements in sleep, arousal, abnormal brain
activation, and pain has important implications...

## Key facts

- **NIH application ID:** 10587972
- **Project number:** 1R01DA054311-01A1
- **Recipient organization:** UNIVERSITY OF SOUTH FLORIDA
- **Principal Investigator:** Christina S McCrae
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $664,119
- **Award type:** 1
- **Project period:** 2023-08-01 → 2028-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10587972

## Citation

> US National Institutes of Health, RePORTER application 10587972, Improving Sleep and Reducing Opioid Use in Individuals with Chronic Pain (1R01DA054311-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10587972. Licensed CC0.

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