# MOUD Comparative Effectiveness Study

> **NIH NIH R01** · BOSTON MEDICAL CENTER · 2021 · $602,367

## Abstract

PROJECT SUMMARY
Opioid overdose deaths remain at crisis levels; however, increasing availability of effective medications for
opioid use disorder (MOUD) are one reason for optimism. Unfortunately, MOUD are underutilized. Real-world
data have identified low MOUD retention rates in contrast with higher retention rates observed in randomized
controlled trials (RCTs). While comparative effectiveness RCTs found that buprenorphine-naloxone and
extended-release naltrexone have similar retention and illicit opioid use, observational studies identify lower
rates of fatal opioid overdose and improved retention with buprenorphine-naloxone. While RCTs are
considered the gold standard for studying causal relationships, external generalizability is limited, and RCTs
have limited power to study relatively rare outcomes such as fatal or nonfatal opioid overdose. The
Massachusetts Public Health Data warehouse (PHD) is a novel near population-level database linking more
than 20 state-based datasets at the individual level. The PHD offers an unparalleled ability to study a breadth
and depth of opioid-related exposures and outcomes, including opioid overdose. The current proposal seeks to
use PHD to emulate target comparative effectiveness trials of a rapidly expanding array of buprenorphine and
naltrexone formulations. We will examine MOUD initiation following opioid detoxification, a common treatment
entry point for individuals at high-risk for subsequent opioid overdose. To advance understanding of the
differences between observational studies and RCTs we will directly compare effect estimates of treatment
retention from an emulated trial in PHD with a reanalysis of the target X:BOT RCT that compared sublingual
buprenorphine-naloxone and extended-release naltrexone. Using the PHD, we will examine additional
outcomes, including fatal and nonfatal opioid overdose. We will leverage the emulated trial framework
developed to study additional high priority comparative effectiveness questions. We will compare outcomes
from initiation of sublingual buprenorphine-naloxone versus buprenorphine extended-release formulations
following opioid detoxification. Finally, while long-term MOUD treatment is the standard of care, many patients
prefer to stop treatment. We will assess the impact of tapering sublingual buprenorphine-naloxone after 3 or 6
months of treatment compared with continued use. The findings of these comparative effectiveness analyses
will inform policy and practice on the coverage and use of an expanding array of MOUD formulations.

## Key facts

- **NIH application ID:** 10279437
- **Project number:** 1R01DA054268-01
- **Recipient organization:** BOSTON MEDICAL CENTER
- **Principal Investigator:** Marc Larochelle
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $602,367
- **Award type:** 1
- **Project period:** 2021-07-01 → 2026-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10279437

## Citation

> US National Institutes of Health, RePORTER application 10279437, MOUD Comparative Effectiveness Study (1R01DA054268-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10279437. Licensed CC0.

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