Development of opioid rapid response system: Protocol for a randomized controlled trial

Contemp Clin Trials. 2022 Apr;115:106727. doi: 10.1016/j.cct.2022.106727. Epub 2022 Mar 13.


Background: Opioid overdoses require a rapid response, but emergency responders are limited in how quickly they can arrive at the scene for administering naloxone. If laypersons are trained to administer naloxone and are notified of overdoses, more lives can be saved.

Objective: This study aimed to examine the feasibility of the Opioid Rapid Response System (ORRS) that recruits, trains, and links citizen responders to overdose events in their community in real-time to administer naloxone. Aim of this paper is to present the protocols for recruiting participants through multiple communication channels; developing and evaluating the online training which has both interactive and asynchronous modules; randomly assigning laypersons to either online naloxone training or waitlist control group; measuring participants' knowledge, skills, and attitudes before and after the training; and distributing intranasal naloxone kits to participants for use in events of overdose in their community.

Methods: Sampling: Utilizing a combination of purposive sampling methods, laypersons from across five Indiana counties who did not self-identify as current first responders were invited to participate.

Design: In this two-arm randomized waitlist-controlled study (N = 220), individuals were assigned into either online training or waitlist control that received the training two weeks later.

Analysis: A linear mixed model will be used for determining the changes in targeted outcomes in the training group and accommodate for fixed and random effects.

Implications: While ORRS can become a community-engaged, cost-effective model for technology-based emergency response for opioid overdoses, study protocols can be useful for other emergency response programs that involve laypersons.

Clinicaltrials: gov Registration Number: NCT04589676.

Publication types

  • Clinical Trial Protocol
  • Research Support, N.I.H., Extramural

MeSH terms

  • Analgesics, Opioid / therapeutic use
  • Drug Overdose*
  • Humans
  • Naloxone / therapeutic use
  • Narcotic Antagonists / therapeutic use
  • Opiate Overdose*
  • Randomized Controlled Trials as Topic


  • Analgesics, Opioid
  • Narcotic Antagonists
  • Naloxone

Associated data