Overdose Risk Management and Naloxone

NCT03933345 | Unknown DMC

• 1 other identifier: 660
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

Brief Summary

A growing body of research underscores the life- and cost-saving advantages of equipping people who use opioids with naloxone, but very little is known about: 1) barriers to naloxone awareness and access, and 2) the potential psychosocial and behavioral impacts of being "protected" by naloxone while engaging in overdose risk behaviors, of using naloxone on someone else, and of surviving an overdose in which naloxone is used. This research will provide insight into both of these domains to yield a richly contextualized understanding of the processes and mechanisms underlying changes in overdose risk behaviors related to naloxone access and use and will illuminate the disparities that may limit access to naloxone for some or result in compensatory behavior following naloxone exposure for others. Findings from this study will provide an empirical basis to strengthen and refine existing overdose prevention efforts and to design tailored interventions to engage opioid users who have recently survived or reversed an overdose.

Conditions

Opioid Use

Keywords

Overdose Risk Behaviors; Opioids; Naloxone; Overdose

Outcome Measures

Primary Outcomes (6)

• Naloxone access

  Number of times offered naloxone

  Lifetime (at baseline)

• Naloxone uptake

  Number of times accepted naloxone when offered

  Lifetime (at baseline)

• Naloxone use

  Number of times used naloxone

  Lifetime (at baseline)

• Naloxone access

  Number of times offered naloxone

  24 months

• Naloxone use

  Number of times used naloxone

  24 months

• Overdose risk behaviors

  Overdose Risk Behavior Scale - a 22 item validated scale that measures past 30-day overdose risk behaviors. See (Development of an Overdose Risk Behavioral Scale: ORBS; Pouget et al., 2017).

  24 months

Study Arms (1)

People who use illicit opioids

The study will recruit an adult-age (18+) sample of 600 people who use illicit opioids (either heroin or prescription opioid analgesics without a doctor's prescription) in New York City using Respondent Driven Sampling.

Other: Study provides naloxone to participants who wish to have it. Not required to accept naloxone and no control.

Interventions

Study provides naloxone to participants who wish to have it. Not required to accept naloxone and no control. OTHER

At enrollment, participants will complete a detailed survey instrument establishing histories of substance use, naloxone exposure, and other potential barriers to the uptake of naloxone training. Because extant research establishes a clear public health and ethical imperative to provide PWUIO with naloxone, we will also offer all participants training to become naloxone-equipped OD responders at enrollment. We will follow the sample for two years using a mixed-methods approach involving text-message-based exposure tracking, monthly surveys using a state-of-the-art online data collection portal, and a qualitative subsample to ensure that naloxone exposures and changes in OD risk behavior are carefully tracked and contextualized by ethnographic data about the psychosocial and sociocultural mechanisms underlying participant experiences.

People who use illicit opioids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population will consist of 600 people who use illicit opioids in New York City.

You may qualify if:

• Adult-age (18+)
• Current illicit opioid use (verified by rapid urine screen)
• Speak English
• Willing to participate

You may not qualify if:

• Unable to comprehend informed consent and/or study procedures.

Sponsors & Collaborators

• National Development and Research Institutes, Inc.: lead
• Brandeis University: collaborator
• Drexel University: collaborator
• New York University: collaborator
• Rhode Island Hospital: collaborator

Study Sites (2)

270 West 25th Street

New York, New York, 10001, United States

RECRUITING

National Development and Research Institutes, Inc.

New York, New York, 10010, United States

RECRUITING

Related Publications (1)

• Pouget ER, Bennett AS, Elliott L, Wolfson-Stofko B, Almenana R, Britton PC, Rosenblum A. Development of an opioid-related Overdose Risk Behavior Scale (ORBS). Subst Abus. 2017 Jul-Sep;38(3):239-244. doi: 10.1080/08897077.2017.1282914. Epub 2017 Jan 23.

  PMID: 28113004 RESULT

MeSH Terms

Conditions

Drug Overdose

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Andrew Rosenblum

  National Development & Research Institutes (NDRI)

  STUDY DIRECTOR

Central Study Contacts

Alexander Bennett, PhD

CONTACT

19174707000; bennett@ndri.org

Luther Elliott, PhD

CONTACT

3473266757; elliott@ndri.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Deputy Director

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: May 1, 2019
• Study Start: April 5, 2019
• Primary Completion: August 1, 2022
• Study Completion: August 31, 2023
• Last Updated: May 1, 2019

Record last verified: 2019-04

Locations

US (2)