# Low-dose buccal buprenorphine: Relative abuse potential and postoperative analgesic acceptability

> **NIH NIH K23** · VANDERBILT UNIVERSITY MEDICAL CENTER · 2024 · $175,681

## Abstract

ABSTRACT
About 25% of the 69,710 U.S. opioid overdose deaths in 2020 involved prescription opioids directly, and many
of the remaining overdose victims started opioid use with prescribed medication. Post-surgical opioid
prescribing comprises an increasing share of opioid prescribing, with considerable risks for misuse, new
persistent opioid use (NPOU), and opioid use disorder (OUD). There is a need to decrease these iatrogenic
risks without compromising postoperative analgesia. Buccal buprenorphine represents a potential alternative to
traditional post-surgical opioid prescribing with known lower respiratory depression risk. However, minimal data
exists regarding whether its administration yields: (1) decreased abuse potential or (2) acceptable analgesia for
acute pain. The Research Training Plan addresses these key gaps in understanding regarding the risk/benefit
ratio of postoperative buccal buprenorphine. Aim 1 involves pharmacodynamic and psychophysical
assessment of abuse potential and analgesia following buccal buprenorphine administration in a controlled
experimental setting. Aim 2 entails a preliminary study assessing the feasibility and acceptability of a
randomized clinical trial of prescribing buccal buprenorphine for postoperative pain management. In each aim,
buccal buprenorphine will be compared with oxycodone, a commonly prescribed postoperative opioid. The
candidate has prior experience with small observational studies and large clinical database studies related to
post-surgical opioids and pain, with several first- and co-first-author publications in major journals. The Career
Development Plan will allow him to gain new proficiencies in the assessment of abuse potential and pain as
well as clinical trial design and execution, biostatistics, grantsmanship, and professional development. Mentor
Dr. Stephen Bruehl specializes in the experimental assessment of the subjective and analgesic response to
opioid administration. Co-mentor Dr. Sharon Walsh performed the seminal studies on buprenorphine
pharmacodynamics and is an expert on OUD. Co-mentors Dr. Chad Brummett and Dr. David Edwards are
authorities on postoperative opioid prescribing, and co-mentor Dr. Benjamin French is a specialist in clinical
trial design and biostatistics. Vanderbilt’s setting is highly conducive to research training and implementation.
This project will set the candidate on course for a career as an independent translational and clinical
investigator. The proposed studies promise to offer insights into whether buccal buprenorphine can serve as
an alternative postoperative analgesic with lower abuse potential. The subsequent planned definitive trial could
reshape post-surgical opioid prescribing patterns.

## Key facts

- **NIH application ID:** 10799614
- **Project number:** 5K23DA057387-02
- **Recipient organization:** VANDERBILT UNIVERSITY MEDICAL CENTER
- **Principal Investigator:** Daniel Larach
- **Activity code:** K23 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $175,681
- **Award type:** 5
- **Project period:** 2023-03-15 → 2028-02-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10799614

## Citation

> US National Institutes of Health, RePORTER application 10799614, Low-dose buccal buprenorphine: Relative abuse potential and postoperative analgesic acceptability (5K23DA057387-02). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10799614. Licensed CC0.

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