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Impact of Federal and State Medications for Opioid Use Disorder (MOUD) Policy Changes During the Pandemic

Comparing Treatment Use, Retention, and Patient Outcomes Pre- and Post-implementation of Federal Policy Changes Regulating Buprenorphine and Methadone Treatment for Opioid Use Disorder

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07232641
Acronym
IMPACT
Enrollment
185810
Registered
2025-11-18
Start date
2026-06-30
Completion date
2029-09-01
Last updated
2026-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder, Opioid Use Disorder, Substance Use Disorders

Keywords

Medications for opioid use disorder (MOUD)

Brief summary

"Gold-standard" medications for opioid use disorder (MOUD) treatment combines FDA-approved medications, primarily methadone and buprenorphine, with behavioral therapies to provide "whole-patient" treatment. Prior to the pandemic, methadone and buprenorphine were subject to greater federal regulations than medications for other substance use disorders, including medication for alcohol use disorder (MAUD), which created barriers to MOUD initiation and retention. These barriers were exacerbated by physical distancing and diminished clinic capacities during the COVID-19 pandemic. To prevent healthcare disruption and expand access to MOUD treatment during the public health emergency, federal and state authorities implemented several MOUD policy changes during the pandemic to reduce barriers to MOUD initiation and retention, which subsequently became permanent. This study is an evaluation of the impacts of these policies on treatment use, retention, and patient outcomes pre- and post-MOUD policy implementation.

Detailed description

A mixed method study design will be implemented for this research study which has 3 specific aims. Aim 1. Examine the long-term effects of MOUD policy changes on MOUD receipt, coverage, retention, and receipt of behavioral therapy, relative to commensurate measures among patients with AUD. Aim 2. Examine the long-term effects of MOUD policy changes on outcomes for patients with OUD, including emergency department (ED) visits, inpatient hospitalization, substance use, relapse, and fatal and non-fatal overdoses, in contrast to pre-/post-period trends among our AUD comparison group. Aim 3. Contextualize longitudinal results using qualitative methods to examine the impacts of MOUD policy changes from the perspectives of veteran patients with OUD, MOUD providers, and the Veteran's Health Administration Substance Use Disorder (VHA SUD) treatment leadership, and actors influencing the reach, effectiveness, adoption, implementation, and maintenance of MOUD policy changes. For Aims 1 and 2, an observational cohort study will be conducted, using an interrupted time-series or difference-in-difference design to evaluate pre/post changes in treatment utilization and patient outcomes related to the nationwide MOUD policy changes introduced in 2020 expanding on access to MOUD treatment. The comparator for these analyses are patients with alcohol use disorder (AUD) for whom COVID-19 treatment disruptions applied but MOUD policies did not. Data will be sourced from the Veteran's Health Administration Corporate Data Warehouse (CDW), including notes and Veteran's Administrations (VA) Mortality Data Repository and Community Care (CC) data. Aim 3 is a qualitative aim for which we will interview VA MOUD providers, VA substance use disorder treatment leadership, and VA patients with OUD.

Interventions

None listed

Sponsors

Boston University
Lead SponsorOTHER
Patient-Centered Outcomes Research Institute
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Substance use disorder (alcohol and/or opioid) documented in the Veteran's Health Administration Corporate Data Warehouse (CDW)

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Change in MOUD/MAUD Retention4 years pre/post policy changeBased on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)
Change in Behavioral Therapy Receipt4 years pre/post policy changeBased on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)
Change in Behavioral Therapy Count4 years pre/post policy changeBased on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)
Change in MOUD/MAUD Receipt4 years pre/post policy changeBased on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)
Change in MOUD/MAUD Coverage4 years pre/post policy changeBased on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)

Secondary

MeasureTime frameDescription
Change in the number of inpatient admissions4 years pre/post policy changeThe count of inpatient admissions based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)
Change in any non-fatal Overdoses4 years pre/post policy changeDefined as the presence of \> International Classification of Diseases (ICD)-10 non-fatal overdose codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)
Change in the count of non-fatal Overdoses4 years pre/post policy changeBased on non-fatal overdose codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)
Change in Substance Use4 years pre/post policy changeDocumented in the electronic Health Record (EHR) and natural language processing large language models (NLP/LLM)
Change in Fatal Overdoses4 years pre/post policy changeBased on fatal overdose codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)
Change in Substance Use Relapse4 years pre/post policy changeDocumented in the electronic Health Record (EHR) and NLP/LLM
Change in any emergency department visits4 years pre/post policy changeReceipt of any vs none emergency department visits based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)
Change in the number of emergency department visits4 years pre/post policy changeThe count of emergency department visits based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)
Change in any inpatient admissions4 years pre/post policy changeReceipt of any vs none inpatient admissions based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)

Countries

United States

Contacts

CONTACTNicholas Livingston, PhD
livingn@bu.edu857-364-6612
PRINCIPAL_INVESTIGATORNicholas Livingston, PhD

BUCA School of Medicine, Psychiatry and VA Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026