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Opioid OverdosePROVIDENTNCT05096429

Preventing Overdose Using Information and Data From the Environment

A study testing PROVIDENT in people with Opioid Overdose and Drug Overdose, run by Brown University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objectives of this project are to leverage surveillance data to predict future overdose outbreaks, and to evaluate the impact of a randomized, statewide, community-level intervention trial to target overdose prevention programs to neighborhoods at highest risk of future overdose deaths. Read more about this study

Who is it for?
Any age
Conditions the study is for
Opioid Overdose, Drug Overdose
What is being tested?
PROVIDENT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
15 Nov 2021to 15 Aug 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Cities and towns in Rhode Island

Who cannot join

  • There are no exclusion criteria

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Brown University School of Public Health

    Providence, Rhode Island, 02912

Other trials in United States

About this study

Official title: Reducing Drug-Related Mortality Using Predictive Analytics: A Randomized, Statewide, Community Intervention Trial

The objectives of this project are to leverage surveillance data to predict future overdose outbreaks, and to evaluate the impact of a randomized, statewide, community-level intervention trial to target overdose prevention programs to neighborhoods at highest risk of future overdose deaths. This study develops and tests an opioid overdose forecasting tool, which will allow other states to identify and deploy interventions to communities at highest risk of opioid-related death. The findings from this study have the potential to significantly improve the allocation of resources to curb the opioid overdose epidemic in the United States.

Read the detailed description

Overdose deaths have skyrocketed in the United States since 1999. The epidemic has prompted widespread federal and state actions, yet the number of people who die of an overdose continues to increase. In light of the accelerating and rapidly evolving overdose epidemic, new strategies are needed to identify communities most at risk, and to utilize resources more effectively to curb overdose deaths. To address these public health priorities, we will develop a forecasting tool to predict overdose deaths before they occur, and then conduct a randomized, statewide, community-level intervention to evaluate the impact of resource targeting based on these predictions. The study will take place in Rhode Island, a state with the 10th highest rate of overdose fatality in 2016. The study has two phases. First, we will develop a predictive analytics model that forecasts future overdose mortality at the neighborhood-level, using publicly available information and data from a multicomponent overdose surveillance system. This tool, called PROVIDENT (Preventing Overdose using Information and Data from the Environment) will be used to predict the likelihood of future overdose deaths in every neighborhood across Rhode Island. As all data to be analyzed as part of this study is collected through ongoing public health surveillance activities and the use of protected health information involves no more than a minimal risk to the privacy of individuals, the institutional review board (IRB) of record approved a waiver of research participants' authorization for use/disclosure of information about them for research purposes, in accordance with 45 Code of Federal Regulations (CFR) § 164.512(i)(2)(iv). Next, we will conduct a randomized policy experiment to evaluate whether targeting overdose prevention interventions to neighborhoods at highest risk reduces overdose morbidity and mortality. The state's department of health will receive PROVIDENT model predictions for half of the 39 cities/towns in Rhode Island. Within these cities/towns, the health department will work with stakeholders to target overdose prevention interventions to neighborhoods with the highest predicted probability of future overdose deaths. Interventions include efforts to: (1) prevent high-risk prescribing (through academic detailing and other educational efforts); (2) expand access to opioid agonist therapy, including buprenorphine and methadone; (3) increase naloxone distribution (through community and pharmacy-based efforts); and (4) expand street-based peer recovery coaching and referrals. Control cities/towns will continue to receive these same interventions, but will not receive information about the neighborhoods at the highest predicted risk of overdose. Fatal and non-fatal opioid overdose rates in the control cities/towns will be compared to those that received the PROVIDENT model predictions. To achieve these aims, we will leverage a unique partnership between an academic institution and a state's health department, which allows for unprecedented access to and sharing of population-based overdose surveillance data. Our results will improve public health decision-making and inform resource allocation to communities that should be prioritized for evidence-based prevention, treatment, recovery, and overdose rescue services. If found to be effective, the PROVIDENT forecasting model will be disseminated to other states, which could adapt the tool to guide resource allocation and maximize public health impact. In sum, this project is highly responsive to a top research priority of the National Institute on Drug Abuse, and directly addresses one of the nation's most challenging public health crises.

Being tested
PROVIDENT
Keywords
fentanyl, naloxone, harm reduction, machine learning, predictive analytics, community intervention, drug overdose, opioids
Medical subject headings
Opiate Overdose, Drug Overdose, Harm Reduction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PROVIDENTBehavioural

    Each of the state's 39 municipalities will be randomised to the intervention (PROVIDENT) or comparator condition. An interactive, web-based tool will be developed to visualize the PROVIDENT model predictions. Municipalities assigned to the treatment arm will receive neighborhood risk predictions from the PROVIDENT model, and state agencies and community-based organizations will direct resources to neighborhoods identified as high risk. Municipalities assigned to the control arm will continue to receive surveillance information and overdose prevention resources, but they will not receive neighborhood risk predictions from this study.

Study groups in NCT05096429
Study groupRoleWhat they receive
InterventionExperimentalWithin these cities/towns, the health department will work with stakeholders to prioritize overdose prevention interventions to neighborhoods with the highest probability of future overdose deaths, as predicted by the PROVIDENT model.
Receives: Behavioral: PROVIDENT
ControlNo interventionCities/towns assigned to the control arm will continue to work with the health department and distribute these interventions at existing resource levels, but without receiving information on predicted probability of overdose risk for specific neighborhoods.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative Incidence of Accidental Fatal and Non-Fatal Drug Overdoses

    The primary outcome is the cumulative incidence of fatal and non-fatal drug overdoses per 10,000 residents. Fatal overdoses will be defined as drug-related deaths deemed accidental by a state medical examiner. Non-fatal overdoses will be defined as emergency medical services (EMS) runs for suspected non-fatal opioid overdoses identified and classified by the Rhode Island Emergency Medical Services Information System (RI-EMSIS). Since patient outcomes are recorded, patients who did not survive or who were dead upon arrival will be excluded to avoid double-counting.

    Measured: 0.5 to 2.75 years following intervention, with assessment of primary outcome at 2.75 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2021
  2. Study start15 Nov 2021
  3. Primary completion15 Aug 2024
  4. Study completion15 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
We will conduct a randomized policy experiment to evaluate whether targeting overdose prevention interventions to neighborhoods at highest risk reduces overdose morbidity and mortality. The state's department of health will receive PROVIDENT model predictions for half of the 39 cities/towns in Rhode Island.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05096429
Sponsor's protocol ID
1910002566
Other IDs
R01DA046620
Acronym
PROVIDENT
Status last verified
Nov 2025
First submitted
15 Oct 2021
Last updated
9 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Marshall BDL, Alexander-Scott N, Yedinak JL, Hallowell BD, Goedel WC, Allen B, Schell RC, Li Y, Krieger MS, Pratty C, Ahern J, Neill DB, Cerda M. Preventing Overdose Using Information and Data from the Environment (PROVIDENT): protocol for a randomized, population-based, community intervention trial. Addiction. 2022 Apr;117(4):1152-1162. doi: 10.1111/add.15731. Epub 2021 Nov 29.

    PubMed 34729851

Questions about this trial

What is this clinical trial studying?

A study testing PROVIDENT in people with Opioid Overdose and Drug Overdose, run by Brown 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: finished, as of the sponsor's last update on 9 Apr 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?

Yes. Results are posted in the registry (first posted 9 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Incidence of Accidental Fatal and Non-Fatal Drug Overdoses (time frame: 0.5 to 2.75 years following intervention, with assessment of primary outcome at 2.75 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05096429, which also lists 1 linked publication.

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 9 Apr 2026.

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