Substance Use DisordersIMPACTNCT07232641
Impact of Federal and State Medications for Opioid Use Disorder (MOUD) Policy Changes During the Pandemic
An observational study of Substance Use Disorders and Alcohol Use Disorder, run by Boston University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders, Alcohol Use Disorder, Opioid Use Disorder
- How many people
- 185,810 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2026to Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Substance use disorder (alcohol and/or opioid) documented in the Veteran's Health Administration Corporate Data Warehouse (CDW)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Medical Center
Boston, Massachusetts, 02130
Nicholas Livingston, PhD, 857-364-6612, livingn@bu.ed
About this study
Official 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
"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.
Read the 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.
- Keywords
- Medications for opioid use disorder (MOUD)
- Medical subject headings
- Substance-Related Disorders, Alcoholism, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in MOUD/MAUD Receipt
Based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 4 years pre/post policy change
Secondary outcomes (9)
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)
Measured: 4 years pre/post policy change
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)
Measured: 4 years pre/post policy change
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)
Measured: 4 years pre/post policy change
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)
Measured: 4 years pre/post policy change
Change in any non-fatal Overdoses
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)
Measured: 4 years pre/post policy change
Change in the count of non-fatal Overdoses
Based on non-fatal overdose codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)
Measured: 4 years pre/post policy change
Change in Fatal Overdoses
Based on fatal overdose codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)
Measured: 4 years pre/post policy change
Change in Substance Use
Documented in the electronic Health Record (EHR) and natural language processing large language models (NLP/LLM)
Measured: 4 years pre/post policy change
Change in Substance Use Relapse
Documented in the electronic Health Record (EHR) and NLP/LLM
Measured: 4 years pre/post policy change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start30 Jun 2026
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 185,810 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Nicholas Livingston, PhD, Principal investigator, BUCA School of Medicine, Psychiatry and VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232641
- Sponsor's protocol ID
- H-46327
- Other IDs
- LTF-2024C2-39670
- Acronym
- IMPACT
- Status last verified
- Jul 2026
- First submitted
- 14 Nov 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07232641
- Acronym / sponsor ID
- IMPACT / H-46327
- Keywords
- Medications for opioid use disorder (MOUD)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 185,810 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Substance use disorder (alcohol and/or opioid) documented in the Veteran's Health Administration Corporate Data Warehouse (CDW)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
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)
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)
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)
9 secondary outcomes
Change in any emergency department visits
Time frame: 4 years pre/post policy change
Change in the number of emergency department visits
Time frame: 4 years pre/post policy change
Change in any inpatient admissions
Time frame: 4 years pre/post policy change
Change in the number of inpatient admissions
Time frame: 4 years pre/post policy change
Change in any non-fatal Overdoses
Time frame: 4 years pre/post policy change
Change in the count of non-fatal Overdoses
Time frame: 4 years pre/post policy change
Change in Fatal Overdoses
Time frame: 4 years pre/post policy change
Change in Substance Use
Time frame: 4 years pre/post policy change
Change in Substance Use Relapse
Time frame: 4 years pre/post policy change
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Related parent grant.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicholas Livingston, PhD principal investigator
BUCA School of Medicine, Psychiatry and VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use Disorders and Alcohol Use Disorder, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicholas Livingston, PhD (857-364-6612, livingn@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MOUD/MAUD Receipt (time frame: 4 years pre/post policy change). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.