NCT05028998

Brief Summary

Our nation is facing the COVID-19 pandemic during an ongoing opioid epidemic. Effective treatment for patients with opioid use problems involves a treatment method called Medication-Assisted Treatment, or MAT. In MAT, patients receive a medication that reduces cravings and withdrawal symptoms and can prevent overdose. Patients also receive counseling. Because the medications that are used in MAT are controlled substances, this treatment is subject to a number of federal regulations. The need for social-distancing during the pandemic would have made following these regulations very difficult for patients and their providers. Because of these difficulties, the federal government eased regulations in March 2020, making it easier for patients to receive MAT with fewer (if any) in-person visits for medication and counseling. Our team is studying the effects of these policy changes on the treatment that patients with opioid use disorder receive and on their outcomes. We are using both quantitative analyses of large, existing databases and qualitative analyses of interviews with patients, providers, and policy-makers to study these effects.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 27, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 31, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

1.9 years

First QC Date

August 27, 2021

Last Update Submit

July 27, 2023

Conditions

Opioid-use DisorderAlcohol Use Disorder

Keywords

opioid use disorder, methadone, buprenorphine

Outcome Measures

Primary Outcomes (5)

  • Aim 1: Prescription medication access

    Medication prescription fills, In-person prescribing, Telehealth prescribing for OUD and AUD (clinical comparator)

    January 2019-December 2019; April 2020-March 2021

  • Aim 1: Patient-provider encounter

    In-person counseling / psychotherapy, Telehealth counseling/ psychotherapy for OUD and AUD (clinical comparator)

    January 2019-December 2019; April 2020-March 2021

  • Aim 2: Treatment retention/discontinuation

    Medication treatment retention, as measured by continuous and treatment, for patients with OUD and AUD (comparator)

    January 2019-December 2019; April 2020-March 2021

  • Aim 2: Adverse outcomes

    Emergency Department visits, Detoxification treatment utilization, Overdose, Death, OUD/AUD Relapse for OUD and AUD (clinical comparator)

    January 2019-December 2019; April 2020-March 2021

  • Aim 3: Semi-structured qualitative interview data from patients, providers, policy makers

    \[Qualitative\] Patient, provider, and policy-maker perspectives regarding OUD treatment and OUD treatment policies, practices, and implementation during COVID-19

    January 2019-December 2019; April 2020-March 2021

Study Arms (10)

Veterans with Opioid Use Disorder receiving care through the Veterans Health Administration

Pre-existing medical records data for these individuals will be part of our Aim 1 and Aim 2 large quantitative database. Additionally, we will be recruiting 30 of these individuals to participate in our Aim 3 qualitative interviews.

Veterans with Alcohol Use Disorder receiving care through the Veterans Health Administration

Pre-existing medical records data for these individuals will be part of our Aim 1 and Aim 2 large quantitative database. We will not be recruiting any of these individuals for Aim 3 qualitative interviews.

Patients with Opioid Use Disorder for whom Market Scan Medicaid Claims data is available

Pre-existing medical records data for these individuals will be part of our Aim 1 and Aim 2 large quantitative database. We will not be recruiting any of these individuals for Aim 3 qualitative interviews.

Patients with Alcohol Use Disorder for whom Market Scan Medicaid Claims data is available

Pre-existing medical records data for these individuals will be part of our Aim 1 and Aim 2 large quantitative database. We will not be recruiting any of these individuals for Aim 3 qualitative interviews.

Patients with Opioid Use Disorder for whom Market Scan Commercial Insurance Claims data is available

Pre-existing medical records data for these individuals will be part of our Aim 1 and Aim 2 large quantitative database. We will not be recruiting any of these individuals for Aim 3 qualitative interviews.

Patients with Alcohol Use Disorder for whom Market Scan Commercial Claims data is available

Pre-existing medical records data for these individuals will be part of our Aim 1 and Aim 2 large quantitative database. We will not be recruiting any of these individuals for Aim 3 qualitative interviews.

Patients with Opioid Use Disorder receiving care outside of Veterans Health Administration

We will be recruiting 30 of these individuals to participate in our Aim 3 qualitative interviews.

Opioid Use Disorder Treatment Providers who provide treatment in the Veterans Health Administration

We will be recruiting 15 of these individuals to participate in our Aim 3 qualitative interviews.

Opioid Use Disorder Providers who treat outside the Veterans Health Administration

We will be recruiting 15 of these individuals to participate in our Aim 3 qualitative interviews.

Opioid Use Disorder Treatment and Policy Decision Makers

We will be recruiting 20 of these individuals to participate in our Aim 3 qualitative interviews.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Veterans Health Administration and non-Veterans Health Administration (commercially and Medicaid-covered individuals) patients with OUD and their matched AUD comparators will be included in Aim 1 and 2 analyses. These represent archival claims (non-Veterans Health Administration data) and electronic health record data (Veterans Health Administration). The population for Aim 3 will include veterans who are current or recent patients of Veterans Health Administration, seeking/having received treatment for OUD at Veterans Health Administration; non-veterans seeking/having received treatment for OUD outside Veterans Health Administration; clinicians who treat patients with OUD within or outside Veterans Health Administration; and policy/decision-makers with expertise in opioid and OUD treatment policy.

You may qualify if:

  • VA patients with OUD who currently, or recently (within the past 6 months) receive(d) treatment for OUD from providers within Veterans Health Administration in the states of Massachusetts, Rhode Island, or New Hampshire.
  • Non-Veteran patients with OUD (N=30) who currently, or recently (within the past 6 months) receive(d) treatment for OUD from providers outside Veterans Health Administration in the states of Massachusetts, Rhode Island, or New Hampshire.
  • VA - OUD treatment providers who currently provide treatment for OUD within Veterans Health Administration, and have been a Veterans Health Administration provider of OUD treatment for at least one year in Massachusetts, Rhode Island, or New Hampshire.
  • Non-VA OUD treatment providers who currently provide treatment for OUD outside of Veterans Health Administration, and have been a provider of OUD treatment for at least one year in Massachusetts, Rhode Island, or New Hampshire.
  • OUD treatment and policy decision-makers who currently or recently (within past 6 months) hold/held positions within federal, state, or private organizations (e.g., Veterans Health Administration, SAMHSA) in which they are responsible for making and/or influencing significant decisions regarding the OUD treatment policy and/or the manner in which these are implemented.

You may not qualify if:

  • Under 18
  • Inability to speak fluent English
  • Inability to provide a clear reporting of their experiences due to current influence of substances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related DisordersAlcoholism

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersAlcohol-Related Disorders

Central Study Contacts

Risa Weisberg, PhD

CONTACT

857-364-4035risa.weisberghawkins@va.gov

Nicholas Livingston, PhD

CONTACT

857-364-6612nicholas.livingston@va.gov

Study Design

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

Study Record Dates

First Submitted

August 27, 2021

First Posted

August 31, 2021

Study Start

September 15, 2021

Primary Completion

July 27, 2023

Study Completion

August 31, 2023

Last Updated

August 1, 2023

Record last verified: 2023-07

Locations

US(1)