NCT07232641

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185,810

participants targeted

Target at P75+ for all trials

Timeline
41mo left

Started May 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Sep 2029

First Submitted

Initial submission to the registry

November 14, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

November 14, 2025

Last Update Submit

April 27, 2026

Conditions

Substance Use DisordersAlcohol Use DisorderOpioid Use Disorder

Keywords

Medications for opioid use disorder (MOUD)

Outcome Measures

Primary Outcomes (5)

  • Change in MOUD/MAUD Receipt

    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

    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

    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

    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

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

    4 years pre/post policy change

Secondary Outcomes (9)

  • Change in any emergency department visits

    4 years pre/post policy change

  • Change in the number of emergency department visits

    4 years pre/post policy change

  • Change in any inpatient admissions

    4 years pre/post policy change

  • Change in the number of inpatient admissions

    4 years pre/post policy change

  • Change in any non-fatal Overdoses

    4 years pre/post policy change

  • +4 more secondary outcomes

Study Arms (1)

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).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Substance-Related DisordersAlcoholismOpioid-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersAlcohol-Related DisordersNarcotic-Related Disorders

Study Officials

  • Nicholas Livingston, PhD

    BUCA School of Medicine, Psychiatry and VA Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicholas Livingston, PhD

CONTACT

(857)364-6612livingn@bu.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 18, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share