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NCT Number: NCT07232641

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

"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.

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Key information

Conditions

Substance Use Disorders Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid Use Disorder Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

VA Medical Center

Boston, Massachusetts, 02130, United States

Location status: Recruiting

Location contact

Nicholas Livingston, PhD

CONTACT

[email protected]

857-364-6612

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Change in MOUD/MAUD Receipt

    Time frame: 4 years pre/post policy change

    Based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)

  2. Change in MOUD/MAUD Coverage

    Time frame: 4 years pre/post policy change

    Based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)

  3. Change in MOUD/MAUD Retention

    Time frame: 4 years pre/post policy change

    Based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)

  4. Change in Behavioral Therapy Receipt

    Time frame: 4 years pre/post policy change

    Based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)

  5. Change in Behavioral Therapy Count

    Time frame: 4 years pre/post policy change

    Based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)

Secondary outcomes

  1. Change in any emergency department visits

    Time frame: 4 years pre/post policy change

    Receipt of any vs none emergency department visits based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)

  2. Change in the number of emergency department visits

    Time frame: 4 years pre/post policy change

    The count of emergency department visits based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)

  3. Change in any inpatient admissions

    Time frame: 4 years pre/post policy change

    Receipt of any vs none inpatient admissions based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)

  4. Change in the number of inpatient admissions

    Time frame: 4 years pre/post policy change

    The count of inpatient admissions based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)

  5. Change in any non-fatal Overdoses

    Time frame: 4 years pre/post policy change

    Defined as the presence of > International Classification of Diseases (ICD)-10 non-fatal overdose codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)

  6. Change in the count of non-fatal Overdoses

    Time frame: 4 years pre/post policy change

    Based on non-fatal overdose codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)

  7. Change in Fatal Overdoses

    Time frame: 4 years pre/post policy change

    Based on fatal overdose codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)

  8. Change in Substance Use

    Time frame: 4 years pre/post policy change

    Documented in the electronic Health Record (EHR) and natural language processing large language models (NLP/LLM)

  9. Change in Substance Use Relapse

    Time frame: 4 years pre/post policy change

    Documented in the electronic Health Record (EHR) and NLP/LLM

Study contacts

Contact information is provided by the study sponsor or research team.

Nicholas Livingston, PhD

CONTACT

[email protected]

857-364-6612

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Acronym: IMPACT

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Nov 18, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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