# Planning Grant for a Clinical Trial Of Cannabidiol For Postoperative Opioid Reduction in Primary Total Knee Arthroplasty

> **NIH NIH R34** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2022 · $68,640

## Abstract

Abstract
Knee osteoarthritis (KOA) is a common and debilitating condition, affecting >14 million Americans. Many KOA
patients require total knee arthroplasty (TKA) to restore adequate function. Postoperatively, pain control is
delivered through multimodal analgesia, including opioids. However, opioids carry significant side effects, and
up to 6.5% of people develop new persistent use following surgery, contributing to the US opioid crisis.
Therefore, developing alternative opioid sparing analgesics is critical for preventing opioid dependence
following surgery. One class of potential opioid-sparing analgesic is cannabidiol (CBD), an active compound in
Cannabis sativa. CBD is non-intoxicating and well tolerated across numerous medical conditions, and exerts
anti-inflammatory, analgesic, and anxiolytic effects in preclinical studies. In recent clinical trials, CBD improved
pain and function in chronic pain due to knee OA and other conditions. Further, small clinical trials have shown
that acutely administered CBD reduces opioid craving and anxiety – the latter being associated with worse
surgical outcomes and greater pain following surgery. Taken together, this evidence suggests that CBD may
be opioid sparing in surgical settings. However, while CBD is widely used by the general public for pain,
arthritis, and anxiety, no studies with CBD have been conducted in post-surgical settings. The proposed study
represents the first step in planning a rigorous, double-blind, randomized controlled trial (RCT) to assess if
CBD is opioid-sparing following surgery. We will leverage the recent FDA approval of Epidiolex (Schedule V,
CBD drug) to ensure study drug standardization and improve generalizability of our findings. The primary
objective is to develop a clinical trial plan to examine whether post-operatively administered CBD is opioid-
sparing following TKA, and to harness the capacity at our institution to prepare and submit a subsequent U01
application to run this trial. Our overarching hypothesis is that CBD exerts opioid-sparing effects through anti-
inflammatory, analgesic, and anxiolytic mechanisms. To develop our plan, we propose two aims. 1: Design a
clinical trial protocol that assesses whether oral CBD reduces opioid consumption following TKA. 2: Complete
the following milestones to prepare us for a successful U01 application: 1) Develop a manual of operating
procedures; 2) Design and test our study database; 3) Develop and test recruitment procedures; 4) Obtain an
Investigational New Drug License; 5) Initiate a IRB application, develop informed consent document; and 6)
Develop a Data Safety and Monitoring Plan. The proposed development plan would be the first step towards
elucidating CBD effects in a post-surgical setting. While our proposed study will be performed in TKA, the
results will have broad implications regarding appropriate CBD use in the postoperative period for a wide
variety of elective surgeries. Our results will contribute to th...

## Key facts

- **NIH application ID:** 10460651
- **Project number:** 5R34AR078435-02
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** Kevin Foxman Boehnke
- **Activity code:** R34 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $68,640
- **Award type:** 5
- **Project period:** 2021-08-02 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10460651

## Citation

> US National Institutes of Health, RePORTER application 10460651, Planning Grant for a Clinical Trial Of Cannabidiol For Postoperative Opioid Reduction in Primary Total Knee Arthroplasty (5R34AR078435-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10460651. Licensed CC0.

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