Understanding the association between sublingual buprenorphine and oral health outcomes
Active Project Grant Awarded Last action
- Award ID
- R01DE033318
- Recipient
-
The University Of Kentucky Research Foundation UEI H1HYA8Z1NTM5
- Awarding agency
-
National Institute of Dental and Craniofacial Research
National Institutes of Health, Department of Health and Human Services
- Obligated
- $3,219,228
Award facts
- Assistance listing
- 93.279 Drug Use and Addiction Research Programs
- Completion date 62% complete
- Originally
- Funding agency
- National Institute on Drug Abuse National Institutes of Health, Department of Health and Human Services
- Place of performance
- Lexington, KY 40506, USA
Award details come from USAspending.gov.
Description
- Abstract
- The standard treatment for opioid use disorder (OUD) involves the use of medications (moud), primarily sublingual (SL) buprenorphine due to its accessibility, efficacy, and tolerability. However, recently the food and drug administration (FDA) published an advisory suggesting SL buprenorphine use is linked to oral disease. While compelling, this advisory is based on adverse event reports and case reports that did control for important confounders such as behavioral and lifestyle factors that may increase the risk in individuals with OUD. More so, these reports were cross-sectional providing limited evidence of rate of progression and incidence of new disease. Additionally, the mechanism by which SL buprenorphine may adversely impact oral health remains unclear. The long-term goal of this project is to quantify adverse oral events associated with SL buprenorphine, facilitating implementation of interventions and practice recommendations to mitigate the burden of oral complications in adults taking SL buprenorphine. The objective of this proposal is to understand if and how SL buprenorphine increases the extent, onset, and progression of oral disease in adults with OUD. Our central hypothesis is that SL buprenorphine causes alterations in the oral environment (e.g., reduction in salivary flow/PH/buffer capacity and microbiome and inflammatory host response changes) that facilitate the incidence and progression of oral disease. We will test this hypothesis with three aims: 1) characterize baseline extent of oral complication and identify risk factors in adults receiving moud, 2) test whether SL buprenorphine is a risk factor for oral disease onset and progression in adults taking moud, and 3) assess whether SL buprenorphine changes saliva quantity, composition, microbial profile, or inflammatory host response in adults taking moud. To accomplish these aims, we propose a prospective, multisite, cohort study across kentucky and north carolina, leveraging a multidisciplinary team of researchers and clinicians to overcome the limitations identified in the literature and expand our understanding of the link between SL buprenorphine and oral disease. We will enroll 372 participants across two states that have been highly impacted by the opioid epidemic and evaluate clinical, radiographic, physiologic, and behavioral information over an 8-month follow-up period. This study is innovative as IT is the first one to: conduct longitudinal follow-up, utilize a comparison moud group, and analyze salivary characteristics to clarify the mechanisms of sublingual buprenorphine-induced disease and will quantify the bacterial composition and inflammatory response and correlate to clinical findings. The proposed research is significant because IT will generate data-driven conclusions about the risks associated with oral disease extent, onset, and progression in adults taking SL buprenorphine. These findings can be used to develop preventive interventions to reduce the burden of oral disease and improve health in this population.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Amendment | $611,983 | |
| Amendment | $0 | |
| Amendment | $0 | |
| Amendment | $0 | |
| Amendment | $0 | |
| Amendment | $0 | |
| Amendment | $0 | |
| Amendment | $625,388 | |
| Amendment | $625,388 | |
| Amendment | $0 | |
| Amendment | $0 | |
| Amendment | $0 | |
| Amendment | $664,797 | |
| Original award | $691,672 |
Show all 14
Subawards
| Subrecipient | Amount | Awarded |
|---|---|---|
| Mountain Area Health Education Center, Inc. | $133,631 | |
| Mountain Area Health Education Center, Inc. | $15,000 | |
| Mountain Area Health Education Center, Inc. | $301,567 |
Quick answers
Who received award R01DE033318?
R01DE033318 was awarded to The University Of Kentucky Research Foundation by National Institute of Dental and Craniofacial Research (National Institutes of Health) on September 21, 2023.
How much is award R01DE033318 worth?
$3,219,228 has been obligated on R01DE033318.
Which agency awarded R01DE033318?
National Institute of Dental and Craniofacial Research (National Institutes of Health) awarded R01DE033318, with funding from National Institute on Drug Abuse (National Institutes of Health).
On GovTribe
See this award's full record
- Every transaction and subaward
- The recipient's other awards and teaming partners
- Similar grant awards
- Ask GovTribe AI about this award