Developing and Testing the Opioid Rapid Response System

NCT04589676 | Completed DMC

• 1 other identifier: 1R41DA053078-01
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

This Phase I SBIR will develop and demonstrate the usability/feasibility of the Opioid Rapid Response System (OSSR) in order to reduce deaths and strain on emergency response systems from opioid overdoses.

Conditions

Opioid Overdose

Keywords

Naloxone

Outcome Measures

Primary Outcomes (1)

• Scale to measure perceptions of training program

  Self report survey scale to measure perceptions of training using agree-disagree scale that yields a composite score of rating that the training is worth the investment of their time and they would recommend it to others in their community.

  3 months

Secondary Outcomes (3)

• Scales to measure knowledge gained from training

  3 months

• Scale to measure perceptions of efficacy in delivering naloxone.

  3 months

• Scale to measure exposure to recruitment campaign

  3 months

Study Arms (2)

Personal recruitment

ACTIVE COMPARATOR

Participants in this training condition will receive recruitment messages that appeal to their personal sense of identity (e.g., you could be a hero if you get trained with naloxone).

Behavioral: Naloxone training

Online training

EXPERIMENTAL

Participants in this training condition will receive recruitment messages that appeal to their communal sense of identity (e.g., your family and friends will thank you for getting trained with naloxone).

Behavioral: Naloxone training

Interventions

Naloxone training BEHAVIORAL

The naloxone training will teach participants about how to appropriately use naloxone in the event of an opioid overdose.

Online training; Personal recruitment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overtly healthy citizen volunteers, aged 18 and over, living in Boone and Hancock Counties of Indiana.
• Able to understand/complete questionnaires, recruitment messages, and training procedures in English.

You may not qualify if:

• Those who have a Boone or Hancock County residential address, but temporarily live in another county or State, so are unable to attend training if assigned to face-to-face naloxone training.
• Those who participate in other research studies which require activities that interfere with the measurements of the current study.

Sponsors & Collaborators

• Real Prevention, LLC: lead
• Indiana University: collaborator

Study Sites (2)

Indiana University

Bloomington, Indiana, 47404, United States

Location

REAL Prevention LLC

Clifton, New Jersey, 07013, United States

Location

Related Publications (14)

• Boslett AJ, Denham A, Hill EL. Using contributing causes of death improves prediction of opioid involvement in unclassified drug overdoses in US death records. Addiction. 2020 Jul;115(7):1308-1317. doi: 10.1111/add.14943. Epub 2020 Feb 27.

  PMID: 32106355 BACKGROUND

• Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016. JAMA. 2016 Apr 19;315(15):1624-45. doi: 10.1001/jama.2016.1464.

  PMID: 26977696 BACKGROUND

• Joudrey PJ, Edelman EJ, Wang EA. Drive Times to Opioid Treatment Programs in Urban and Rural Counties in 5 US States. JAMA. 2019 Oct 1;322(13):1310-1312. doi: 10.1001/jama.2019.12562.

  PMID: 31573628 BACKGROUND

• Cosby AG, McDoom-Echebiri MM, James W, Khandekar H, Brown W, Hanna HL. Growth and Persistence of Place-Based Mortality in the United States: The Rural Mortality Penalty. Am J Public Health. 2019 Jan;109(1):155-162. doi: 10.2105/AJPH.2018.304787. Epub 2018 Nov 29.

  PMID: 30496008 BACKGROUND

• Compton WM, Jones CM, Baldwin GT. Relationship between Nonmedical Prescription-Opioid Use and Heroin Use. N Engl J Med. 2016 Jan 14;374(2):154-63. doi: 10.1056/NEJMra1508490. No abstract available.

  PMID: 26760086 BACKGROUND

• Chen Q, Larochelle MR, Weaver DT, Lietz AP, Mueller PP, Mercaldo S, Wakeman SE, Freedberg KA, Raphel TJ, Knudsen AB, Pandharipande PV, Chhatwal J. Prevention of Prescription Opioid Misuse and Projected Overdose Deaths in the United States. JAMA Netw Open. 2019 Feb 1;2(2):e187621. doi: 10.1001/jamanetworkopen.2018.7621.

  PMID: 30707224 BACKGROUND

• Flood-Grady E, Clark VC, Bauer A, Morelli L, Horne P, Krieger JL, Nelson DR. Evaluating the Efficacy of a Registry linked to a Consent to Re-Contact Program and Communication Strategies for Recruiting and Enrolling Participants into Clinical Trials. Contemp Clin Trials Commun. 2017 Dec;8:62-66. doi: 10.1016/j.conctc.2017.08.005. Epub 2017 Aug 24.

  PMID: 29503877 BACKGROUND

• Lewis CR, Vo HT, Fishman M. Intranasal naloxone and related strategies for opioid overdose intervention by nonmedical personnel: a review. Subst Abuse Rehabil. 2017 Oct 11;8:79-95. doi: 10.2147/SAR.S101700. eCollection 2017.

  PMID: 29066940 BACKGROUND

• Krieger JL, Palmer-Wackerly A, Dailey PM, Krok-Schoen JL, Schoenberg NE, Paskett ED. Comprehension of Randomization and Uncertainty in Cancer Clinical Trials Decision Making Among Rural, Appalachian Patients. J Cancer Educ. 2015 Dec;30(4):743-8. doi: 10.1007/s13187-015-0789-0.

  PMID: 25608719 BACKGROUND

• Ray AE, Greene K, Hecht ML, Barriage SC, Miller-Day M, Glenn SD, Banerjee SC. An E-Learning Adaptation of an Evidence-Based Media Literacy Curriculum to Prevent Youth Substance Use in Community Groups: Development and Feasibility of REAL Media. JMIR Form Res. 2019 May 9;3(2):e12132. doi: 10.2196/12132.

  PMID: 31094328 BACKGROUND

• Hecht ML, Marsiglia FF, Elek E, Wagstaff DA, Kulis S, Dustman P, Miller-Day M. Culturally grounded substance use prevention: an evaluation of the keepin' it R.E.A.L. curriculum. Prev Sci. 2003 Dec;4(4):233-48. doi: 10.1023/a:1026016131401.

  PMID: 14598996 BACKGROUND

• Choi HJ, Krieger JL, Hecht ML. Reconceptualizing efficacy in substance use prevention research: refusal response efficacy and drug resistance self-efficacy in adolescent substance use. Health Commun. 2013;28(1):40-52. doi: 10.1080/10410236.2012.720245.

  PMID: 23330857 BACKGROUND

• Hecht ML, Jayawardene W, Henderson C, Pezalla A, Flood-Grady E, Krieger JL, Frederick A, Parker M, Ables E. Developing the Opioid Rapid Response System for Lay Citizen Response to the Opioid Overdose Crisis: a Randomized Controlled Trial. Prev Sci. 2023 Oct;24(7):1386-1397. doi: 10.1007/s11121-023-01588-0. Epub 2023 Sep 22.

  PMID: 37737966 DERIVED

• Jayawardene W, Pezalla A, Henderson C, Hecht M. 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.

  PMID: 35296414 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Opiate Overdose

Condition Hierarchy (Ancestors)

Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders

Study Officials

• Michael Hecht, PhD

  REAL Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Model Details: An unblinded, two-arm, parallel group cluster-randomized trial with non-random cluster sampling will be conducted in two Indiana counties to establish the usability and feasibility of ORRS and its recruitment and training components.

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 19, 2020
• Study Start: December 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 7, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)