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

May 26, 2026 updated by: Boston University

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

"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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

185810

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nicholas Livingston, PhD
  • Phone Number: 857-364-6612
  • Email: livingn@bu.edu

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02130
        • Recruiting
        • VA Medical Center
        • Contact:
          • Nicholas Livingston, PhD
          • Phone Number: 857-364-6612
          • Email: livingn@bu.ed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A quasi-experimental and comparative interrupted time-series observational cohort study design will be used to compare trends across the pre- and post-MOUD policy change years, between mutually exclusive groups of patients with OUD and AUD (and no co-occurring OUD), who will be matched 1:1 on age, gender, race, rural/urban residence, and state for the pre (03/2016-02/2020) and post periods (03/2020-02/2024).

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
VA Patients with substance use disorder
Mutually exclusive groups of patients with OUD and AUD (and no co-occurring OUD), who will be matched 1:1 on age, gender, race, rural/urban residence, and state for the the pre (03/2016-02/2020) and post periods (03/2020-02/2024).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
4 years pre/post policy change
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)
4 years pre/post policy change
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 years pre/post policy change
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)
4 years pre/post policy change
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)
4 years pre/post policy change

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
4 years pre/post policy change
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)
4 years pre/post policy change
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 years pre/post policy change
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)
4 years pre/post policy change
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)
4 years pre/post policy change
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)
4 years pre/post policy change
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)
4 years pre/post policy change
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)
4 years pre/post policy change
Change in Substance Use Relapse
Time Frame: 4 years pre/post policy change
Documented in the electronic Health Record (EHR) and NLP/LLM
4 years pre/post policy change

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University

Collaborators

Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Nicholas Livingston, PhD, BUCA School of Medicine, Psychiatry and VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 18, 2025

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-46327
  • LTF-2024C2-39670 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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