NCT04372238: RAPIDS

The Rhode Island Prescription and Illicit Drug Study

Completed NA Results posted Last updated 24 August 2025

What this trial tests

NA trial testing RAPIDS Intervention in Opioid Overdose in 509 participants. Completed in 29 February 2024.

Timeline

31 August 2020

Primary endpoint
29 February 2024

29 February 2024

Quick facts

Lead sponsor	Brown University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	509
Start date	31 August 2020
Primary completion	29 February 2024
Estimated completion	29 February 2024
Sites	1 location across United States

Drugs / interventions tested

• RAPIDS Intervention
• Standard OEND

Conditions studied

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

Sponsor

Brown University

Who can join

Adults 18 to 65, 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.

Number of People Identified Has Having One or More Overdose Among RAPIDS Trial Participants Primary · 12 months post-randomization

A composite measure was created in order to be able to create a count of overdoses experienced at 6 or 12 months post baseline. This was from a combination of sefl-reported data, and administrative data.

Group	Value	95% CI
RAPIDS Intervention	48
Standard OEND	36

Accidental Non-fatal Overdose in the Past Month Primary · 12 months post-randomization

At each visit, we asked participants a yes or no question as to whether they experienced an overdose in the last month. This self-reported outcome was creating by taking the number of people who reported an overdose at a given time increment and dividing it by the total number of visits completed at that time increment. We did this for each arm. So for example, at month 1, the calculation would have been \[number of intervention participants reporting an overdose at baseline\]/\[total visits completed by intervention participants at month 1\]

Month 1

Group	Value	95% CI
RAPIDS Intervention	5.4
Standard OEND	2.7

Month 2

Group	Value	95% CI
RAPIDS Intervention	5.6
Standard OEND	4.6

Month 3

Group	Value	95% CI
RAPIDS Intervention	3.4
Standard OEND	4.0

Month 6

Group	Value	95% CI
RAPIDS Intervention	10.6
Standard OEND	4.3

Month 12

Group	Value	95% CI
RAPIDS Intervention	5.3
Standard OEND	11.7

The Number of Fatal Overdose Events Secondary · 12 months post-randomization

The number of fatal overdoses experienced throughout 12 month enrollment in the study, measured using Rhode Island Department of Health data

Group	Value	95% CI
RAPIDS Intervention	9
Standard OEND	7

Number of Participants With Positive Dry Blood Spot Samples Secondary · 12 months post randomization

As part of the dry blood spot supplement, we gathered dry blood spots from participants at baseline and 6 and 12 months post randomization. This outcome assess how many participants in each arm had a positive fentanyl sample. Because of protocols at Brown University related to biosafety, we were only able to collect dry blood spots from participants who we met with at our study offices. We could not get samples from those who we recruited from SSPs

Group	Value	95% CI
RAPIDS Intervention	34
Standard OEND	35
RAPIDS Intervention	86
Standard OEND	79
RAPIDS Intervention	125
Standard OEND	128

Adverse events — posted to ClinicalTrials.gov

Time frame: Each participant was assessed for all adverse events at an on-going basis for up to 15 months following enrollment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

RAPIDS Intervention

Serious: 15/245 (6%)

Deaths: 9/245

Standard OEND

Serious: 12/242 (5%)

Deaths: 7/242

Serious adverse events (1 terms)

Reaction	System	RAPIDS Intervention	Standard OEND
Non-fatal overdose	Injury, poisoning and procedural complications	—	—

Most-reported serious reactions: Non-fatal overdose.

Data from ClinicalTrials.gov NCT04372238 adverse events section.

Sponsor's own description

This study will test the efficacy of a novel drug-checking intervention to prevent fatal and non-fatal overdose among people who use drugs (PWUD), who are 18-65 years old at the time of enrollment. The investigators will evaluate whether the incorporation of rapid fentanyl testing into a theory-driven overdose education and prevention intervention reduces rates of overdose compared to standard overdose education and naloxone distribution. Results from this study will significantly improve public health efforts to address the fentanyl overdose epidemic and reduce harms associated with exposure to drugs contaminated with fentanyl. This is a full clinical trial, building on the previously approved fentanyl-test-strip pilot study (2016-2017), the results of which have recently been published.(Krieger et al., 2018)

Publications & conference data

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

1. A randomized clinical trial of a theory-based fentanyl overdose education and fentanyl test strip distribution intervention to reduce rates of opioid overdose: study protocol for a randomized controlled trial.
   Jacka BP, Goldman JE, Yedinak JL, Bernstein E, et al · · 2020 · cited 19× · PMID 33243291 · DOI 10.1186/s13063-020-04898-8
2. Correlates of fentanyl preference among people who use drugs in Rhode Island.
   Napoleon SC, Park CJ, Goldman J, Li Y, et al · · 2024 · cited 2× · PMID 39272059 · DOI 10.1186/s12954-024-01089-5
3. A Randomised Clinical Trial of a Theory-Based Fentanyl Overdose Education and Fentanyl Test Strip Distribution Intervention to Reduce Rates of Opioid Overdose: Study Protocol for A Randomized Controlled Trial
   Jacka B, Goldman JE, Yedinak J, Bernstein E, et al · · 2020 · DOI 10.21203/rs.3.rs-45321/v1