Impact of Federal and State Medications for Opioid Use Disorder (MOUD) Policy Changes During the Pandemic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBoston University
About this trial
"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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Substance use disorder (alcohol and/or opioid) documented in the Veteran's Health Administration Corporate Data Warehouse (CDW)
Disqualifiers
None
Trial 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).
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
185,810 Participants
are grouped into 1 trial groupGroup A: VA Patients with substance use disorder
Trial outcomes
Primary outcomes
1
Change in MOUD/MAUD Receipt
Based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)
Time frame
4 years pre/post policy change2
Change in MOUD/MAUD Coverage
Based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)
Time frame
4 years pre/post policy change3
Change in MOUD/MAUD Retention
Based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)
Time frame
4 years pre/post policy change4
Change in Behavioral Therapy Receipt
Based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)
Time frame
4 years pre/post policy changeSecondary outcomes
1
Change in any emergency department visits
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)
Time frame
4 years pre/post policy change2
Change in the number of emergency department visits
The count of emergency department visits based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)
Time frame
4 years pre/post policy change3
Change in any inpatient admissions
Receipt of any vs none inpatient admissions based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)
Time frame
4 years pre/post policy change4
Change in the number of inpatient admissions
The count of inpatient admissions based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)
Time frame
4 years pre/post policy changeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Boston University
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov