NCT05096429: PROVIDENT

Preventing Overdose Using Information and Data From the Environment

Completed NA Results posted Last updated 9 April 2026

What this trial tests

NA trial testing PROVIDENT in Opioid Overdose in 39 participants. Completed in 15 August 2024.

Timeline

15 November 2021

Primary endpoint
15 August 2024

15 August 2024

Quick facts

Lead sponsor	Brown University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	39
Start date	15 November 2021
Primary completion	15 August 2024
Estimated completion	15 August 2024
Sites	1 location across United States

Drugs / interventions tested

• PROVIDENT

Conditions studied

• Opioid Overdose — all drugs for Opioid Overdose →
• Drug Overdose — all drugs for Drug Overdose →

Sponsor

Brown University

Who can join

Eligibility, any sex, with Opioid Overdose or Drug Overdose. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cumulative Incidence of Accidental Fatal and Non-Fatal Drug Overdoses Primary · 0.5 to 2.75 years following intervention, with assessment of primary outcome at 2.75 years

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.

Group	Value	95% CI
Intervention	43.5
Control	37.1

Number of Participants Engaged in Implementation Activities Secondary · At the time of participation in implementation evaluation activities (surveys, focus groups, or interviews)

Number of staff from participating community-based harm reduction organizations who engaged in implementation evaluation activities, including technical assistance surveys, focus groups, and key informant interviews conducted during the implementation substudy. This outcome reflects participation in implementation evaluation activities conducted as a substudy within the PROVIDENT trial; results are reported as aggregated counts of participants engaged in each activity. Participants may have contributed to more than one implementation activity.

Participants completing implementation surveys

Group	Value	95% CI
Implementation Substudy: Staff at Community-Based Organizations	39

Participants participating in focus groups

Group	Value	95% CI
Implementation Substudy: Staff at Community-Based Organizations	12

Participants participating in key informant interviews

Group	Value	95% CI
Implementation Substudy: Staff at Community-Based Organizations	7

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Preventing Overdose Using Information and Data from the Environment (PROVIDENT): protocol for a randomized, population-based, community intervention trial.
   Marshall BDL, Alexander-Scott N, Yedinak JL, Hallowell BD, et al · · 2022 · cited 19× · PMID 34729851 · DOI 10.1111/add.15731
2. PROVIDENT: Development and Validation of a Machine Learning Model to Predict Neighborhood-level Overdose Risk in Rhode Island.
   Allen B, Schell RC, Jent VA, Krieger M, et al · · 2024 · cited 10× · PMID 38180881 · DOI 10.1097/ede.0000000000001695
3. An Overdose Forecasting Dashboard for Local Harm-Reduction Response.
   Krieger M, Yedinak J, Duong E, Macmadu A, et al · · 2025 · cited 4× · PMID 40325596 · DOI 10.1177/15248399251335620
4. "Sometimes I'm interested in seeing a fuller story to tell with numbers" Implementing a forecasting dashboard for harm reduction and overdose prevention: a qualitative assessment.
   Gray JY, Krieger M, Skinner A, Parker S, et al · · 2025 · cited 4× · PMID 40055691 · DOI 10.1186/s12889-025-22004-y
5. Assessing User Engagement With an Interactive Mapping Dashboard for Overdose Prevention Informed by Predictive Modeling in Rhode Island.
   Skinner A, Neill DB, Allen B, Krieger M, et al · · 2025 · cited 1× · PMID 40694437 · DOI 10.1097/phh.0000000000002200