An observational study in Opioid Use Disorder, Opioid Overdose and Death, sponsored by Kaiser Permanente. Active, not recruiting at 1 site in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-10-17.
Sponsored by Kaiser Permanente · Observational
Among 56 studies in Opiate Overdose with a site in United States — 8 open to participants now, 15 under way, none of them phase 3. Opiate Overdose · United States.
Among the 56 studies in Opiate Overdose with a site in United States, this one is the 3rd largest by enrollment of the 12 observational ones, is one of 5 that started in 2023, is one of 12 observational ones, reaches primary completion later than 0 of the 14 other live ones, and was the 38th registered.
70 studies on the registry are indexed under Opiate Overdose; 11 are open to participants now.
This study's enrollment of 27,257 is above the median of 284 across 16 observational studies indexed under Opiate Overdose.
Browse Opiate Overdose studies →8 of the 56 studies in Opiate Overdose with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 8 Opiate Overdose studies recruiting now, 6 (75%) set no upper age limit and 2 (25%) stop at 75 or younger; 1 take children under 18; 3 take healthy volunteers.
This study: 16 Years and older · all sexes · no healthy volunteers.
The full table on the hub →56 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 5 started in 2023.
Median enrollment 184 across the 44 interventional studies, 106 across the 12 observational. Of the 35 that completed or were terminated, 15 (43%) have results posted.
8 of 56 have an industry lead sponsor. The 10 most frequent:
Kaiser Permanente is the lead sponsor of 393 studies on the registry; 43 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Kaiser Permanente has 2 studies filed under Opiate Overdose — fewer than ten, so there is no comparison to draw.
1 of the studies in Opiate Overdose with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05713695University of Massachusetts, WorcesterSupporting Treatment Access and Recovery Through Linkage and Support | 2026-12 |
Among the 56 studies in Opiate Overdose with a site in United States, from their registry updates:
The goal of this multi-site observational cohort study is to link electronic health records (EHR) with novel data sources to examine insurance instability and its association with all-cause and overdose mortality in adult patients who received medications for opioid use disorder (MOUD). The main objectives of the study are:
Amidst the current opioid epidemic, the incidence of opioid use disorder (OUD) has increased and medication-based treatments for opioid use disorder (MOUD) remain underutilized. While long-term MOUD is generally associated with improved health and mortality outcomes, maintaining continuous health insurance coverage is a significant challenge to sustained treatment access. Patients with OUD are likely susceptible to experiencing insurance instability due to volatile employment and variable eligibility for public insurance, which results in frequent plan changes and critical coverage gaps. The economic crisis associated with the current COVID-19 pandemic may result in greater insurance coverage instability and losses, which would leave patients with OUD even more vulnerable. High-risk care transitions and significant disruption of treatment, including discontinuation of OUD treatment, increases risk of relapse, overdose, and mortality. Further, heightened vulnerability to insurance instability among racial/ethnic minorities may contribute to observed disparities in addiction treatment access and retention. Despite the potential for insurance instability to create significant barriers to OUD treatment continuity, current knowledge regarding its health and mortality impacts is limited due to the challenge of capturing and evaluating patient outcomes after disenrollment from health systems.
To address this knowledge gap, this research study will examine the association of health insurance instability and mortality risk among patients receiving buprenorphine treatment for opioid use disorder in a multi-site cohort study, leveraging data across four diverse health systems in the US.
Findings from the study can inform strategies to ensure treatment continuity and promote well-being for patients vulnerable to insurance instability, from utilizing insurance navigators to establishing standards for bridge prescriptions of MOUD during enrollment transitions, and developing policies to address coverage gaps, such as insurance subsidies for people with OUD using opioid settlement funds. Additionally, as EHR data are increasingly important for pragmatic trials, this study will also advance intervention research by identifying data sources and methods to address bias from loss to follow-up, a common concern across clinical trials.
70 studies on the registry are indexed under Opiate Overdose; 11 are open to participants now.
This study's enrollment of 27,257 is above the median of 284 across 16 observational studies indexed under Opiate Overdose.
Browse Opiate Overdose studies →Kaiser Permanente is the lead sponsor of 393 studies on the registry; 43 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Compared within Opiate Overdose, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Opioid-Related Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
We anticipate a study population of >20,000 patients based on preliminary data. There will be no study exclusion criteria based on gender, race, or ethnicity.
The retrospective cohort study will consist of patients 16 years and older who received MOUD between January 1, 2012, through December 31, 2021, with follow-up through December 31, 2022. Evidence of MOUD will be determined by (1) buprenorphine with or without an OUD diagnosis and (2) naltrexone (injectable extended-release (XR) or oral; oral naltrexone is included because it may be prescribed prior to the transition to XR naltrexone) with an OUD diagnosis from pharmacy dispensing or orders data.
Patients who are enrolled on health plans during active MOUD treatment.
Other: No intervention, observational retrospective study
Patients who disenrolled from health plans during active MOUD treatment.
Other: No intervention, observational retrospective study
No intervention
All-cause mortality
Death and cause-of-death data from the National Death Index (NDI) will serve as the primary data source for outcomes. Outcome will be identified across follow-up from start of treatment and up to one year after disenrollment from the health system.
Time frame: January 1, 2012 - December 31, 2022
Drug and alcohol-related overdose mortality
Death and cause-of-death data from the National Death Index (NDI) will serve as the primary data source for outcomes. Outcome will be identified across follow-up from start of treatment and up to one year after disenrollment from the health system.
Time frame: January 1, 2012 - December 31, 2022
Started Mar 2023 (actual). Primary completion is estimated for Feb 2025, 22 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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