Evaluating changes in opioid treatment policies during COVID-19
The Impact of COVID-19-related Medication Assisted Treatment Policy Changes on Care and Outcomes for Patients With Opioid Use Disorder
This study looks at how changes in opioid treatment rules during COVID-19 affected people with opioid use disorder and their care experiences.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston VA Research Institute, Inc. Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05028998 on ClinicalTrials.gov |
What this trial studies
This study examines the impact of relaxed federal regulations on Medication-Assisted Treatment (MAT) for opioid use disorder (OUD) during the COVID-19 pandemic. By utilizing a mixed-methods approach, researchers will analyze large datasets to assess how these policy changes affected patient care and outcomes. The study also includes qualitative interviews with patients and providers to gather insights on their experiences with the modified treatment protocols. The goal is to understand the effectiveness of these policy interventions in maintaining access to treatment while ensuring patient safety.
Who should consider this trial
Good fit: Ideal candidates include veterans and non-veterans with opioid use disorder who have received treatment within the past six months in Massachusetts, Rhode Island, or New Hampshire.
Not a fit: Patients who do not have opioid use disorder or those who have not received treatment in the specified regions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with opioid use disorder, particularly in crisis situations.
How similar studies have performed: Other studies have shown success in evaluating policy changes in substance use treatment, indicating that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Data for Aims 1 and 2 will be archival. Patients with OUD and their propensity score-matched AUD comparators will be included for Aims 1 and 2. No other patients from these larger datasets will be included. In/exclusion below pertain to Aim 3 qualitative interviews: Inclusion Criteria: * 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. Exclusion Criteria: * Under 18 * Inability to speak fluent English * Inability to provide a clear reporting of their experiences due to current influence of substances
Where this trial is running
Boston, Massachusetts
- VA Boston Healthcare System — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Risa Weisberg, PhD
- Email: risa.weisberghawkins@va.gov
- Phone: 857-364-4035
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.