# CTN145: Standard versus High Dose ED-Initiated Buprenorphine Induction Administrative Supplement 1

> **NIH NIH UG1** · YALE UNIVERSITY · 2024 · $252,248

## Abstract

Abstract
This administrative supplement will fund the central pharmacy and urine drug screening activities
reassigned to Lead Investigators at Yale University and not previously supported in the original funded
application described as follows. Drug overdoses in the U.S. increased to over 107,000 in the year ending
January 2022 including > 80,000 involving opioids, representing a 24% increase from the prior year. Despite
improved outcomes and decreased all-cause mortality among individuals with opioid use disorder (OUD) who
receive opioid agonist treatment, only 11% of individuals with OUD receive medications for opioid use disorder.
Narrowing the treatment gap by expanding access to treatment beyond specialized drug treatment settings is a
public health priority, and the Emergency Department (ED), offering access 24 hours, 7 days a week, 365 days
a year, is a logical point of intervention. ED patients have a disproportionately high prevalence of OUD, and for
many, the ED is the primary or only access point in the healthcare system. There are currently no controlled,
prospective studies comparing dosing strategies for buprenorphine induction in the ED. We
propose
a
multisite
randomized double-blind, double-dummy, clinical trial of ED patients with moderate to severe OUD (N=360)
from 4 geographically diverse EDs to compare Standard ED Dose Induction (SDI; 8 mg) with High Dose
Induction (HDI; 24 mg) to evaluate AIM 1: Engagement in continuing OUD treatment at 10 days and AIM 2:
Differences in outcomes of craving, tolerability, withdrawal symptoms, and use of illicit drugs. We hypothesize
that patients assigned to the HDI group will be more likely to be engaged in OUD treatment at 10 days post ED
enrollment (primary outcome), and will describe less craving, less withdrawal symptoms and less use of illicit
drugs during the 10 days post ED buprenorphine induction. Additional outcomes will be the development of
ED protocols, and evaluation of safety, feasibility, and acceptability. The primary outcome of engagement in
treatment at 10 days as well as treatment at day 30 will be verified by the treating clinician. Assessment of
craving, withdrawal symptoms and use of illicit drugs will be obtained by daily Qualtrics phone surveys. The
planned study sample and the proposed analytical methods will allow for additional meaningful exploratory
evaluations of potential differential effects of gender, race, ethnicity, housing instability, insurance status, and
use of fentanyl, and other polysubstance use such as stimulants, sedatives, and alcohol. An accelerated
induction
typical
engagement
process that achieves t herapeutic buprenorphine levels in less than 3-4 hours compared to the
2-3 days could potentially increase safety during the crucial gap between ED discharge and
in continuation treatment by limiting illicit opioid use and encouraging follow up visits for OUD
treatment.

## Key facts

- **NIH application ID:** 11094445
- **Project number:** 3UG1DA015831-23S2
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** Gail D'Onofrio
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $252,248
- **Award type:** 3
- **Project period:** 2024-06-01 → 2025-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11094445

## Citation

> US National Institutes of Health, RePORTER application 11094445, CTN145: Standard versus High Dose ED-Initiated Buprenorphine Induction Administrative Supplement 1 (3UG1DA015831-23S2). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/11094445. Licensed CC0.

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