Increasing Naloxone Access for Persons Who Use Opioids

October 27, 2023 updated by: Michelle Sisson, M.A., University of Alabama at Birmingham

Increasing Naloxone Access for Persons Who Use Opioids: An Online Recruitment and Training Approach to Opioid Overdose Education and Naloxone Distribution

Deaths relating to opioid overdose have rapidly increased over the past two decades. Due to the serious public health concern of the opioid epidemic, federal agencies recommend employing various harm reduction interventions. The implementation of Opioid Overdose Education and Naloxone Distribution (OEND) programs is effective in reducing opioid overdose mortality, yet these programs do not reach many high-risk individuals. Traditionally, OEND program venues are found in large, urban medical centers, drug treatment facilities, and needle exchange programs. Identifying unreached, high-risk individuals and providing training and naloxone kits through online recruitment could significantly expand access to this life-saving intervention. The primary goal of the current proposed project is to examine the acceptability and feasibility of online recruitment, online opioid overdose and naloxone administration education, and postal distribution of naloxone kits.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Drug overdose is the leading cause of accidental death in the United States, with over 65% of drug related fatalities resulting from the use of opioids. The continually increasing rates of opioid overdose deaths in the last two decades have led to the declaration of an opioid epidemic. Over a brief 15-year period, from 1999-2014, drug overdose related deaths tripled and rates have continued to sharply escalate since then. Federal agencies have responded to this crisis with various recommendations including enhancing harm reduction approaches such as naloxone distribution. Naloxone is an opioid antagonist that can be used to reverse opioid overdose. Though it is typically administered in Emergency Departments, laypersons have recently been successfully trained through Opioid Overdose Education and Naloxone Distribution (OEND) programs to recognize signs of opioid overdose and perform timely administration of naloxone in homes and community settings while awaiting medical services. Several studies have demonstrated that OEND programs effectively reduce opioid overdose mortality and are safe and cost-effective. However, OEND programs are typically implemented in urban areas as part of large medical center research programs, needle exchanges, or drug treatment programs. Individuals living in areas without these programs or services lack access to critical and life-saving OEND. The current proposal will examine the acceptability and feasibility of online recruitment, online opioid overdose education, and postal distribution of naloxone kits (N=80). Opioid users at risk for overdose will be recruited online through Craigslist. If eligible, participants will complete an opioid use questionnaire and will indicate if they are interested in receiving opioid overdose and naloxone administration training. If interested, they will complete pre- and post-intervention knowledge questionnaires, engage in audiovisual training, and half will be randomized to receive a naloxone kit in the mail while the other half will be given information on where they can receive a naloxone kit. All participants will complete remote follow-up assessments at 1, 2, and 3 months post study to evaluate naloxone kit use and outcomes. This study will evaluate a novel approach to providing OEND to individuals with otherwise limited access to this type of intervention. Successful implementation of remote OEND through this project would support future employment of similar remote programs to expand this critical harm reduction strategy to high-risk individuals in areas lacking traditional OEND programs.

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36201
        • Craigslist
      • Gadsden, Alabama, United States, 35901
        • Craigslist
      • Mobile, Alabama, United States, 36695
        • Craigslist
      • Montgomery, Alabama, United States, 36117
        • Craigslist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years of age or older
  • Current or past six months illicit use of opioids
  • Electronic device access for online survey completion
  • Willing to provide email address to receive survey link and compensation
  • Able to read and speak English
  • Willing to provide their contact information and that of two friends/family members
  • Permanent address for mailing of naloxone kit
  • Does not currently have a naloxone kit in possession

Exclusion Criteria:

  • Contraindication for naloxone (known severe allergic reaction)
  • Cognitive impairment or unstable psychiatric condition that interferes with the informed consent process

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Opioid Overdose Education and Naloxone Distribution
Participants will engage in online audiovisual training focused on recognizing the signs of an opioid overdose and the procedural steps for how to administer naloxone. Participants randomized to this arm will be provided with a naloxone nasal spray kit (4mg).
Drug: Opioid Overdose Education with Naloxone Distribution
Online audiovisual training focused on recognizing the signs of an opioid overdose and administering naloxone. Participants are provided with a naloxone kit.
Other Names:
  • Narcan
Active Comparator: Opioid Overdose Education
Participants will engage in online audiovisual training focused on recognizing the signs of an opioid overdose and the procedural steps for how to administer naloxone. Participants randomized to this arm will receive information about pharmacies in their area where they can purchase a naloxone kit.
Drug: Opioid Overdose Education
Online audiovisual training focused on recognizing the signs of an opioid overdose and administering naloxone. Participants are provided with information on where they can obtain a naloxone kit.
Other Names:
  • Narcan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Participants That Completed the Training in 6 Months
Time Frame: 6 months
Feasibility of online opioid overdose education and remote naloxone distribution as indicated by recruitment of at least 80 total participants in 6 months. There was not a calculated measure, and this aspect of feasibility was based on ability to recruit a set number of participants in a predetermined amount of time.
6 months
Change in Participant Knowledge of Opioid Overdose Response Procedures
Time Frame: 6 months
Mean change in participant knowledge as indicated by difference in scores on pre- and post-training knowledge questionnaires on a scale of 1 to 9 where 9 indicates greater knowledge.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Michelle Sisson, MA, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2021

Primary Completion (Actual)

January 13, 2022

Study Completion (Actual)

January 13, 2022

Study Registration Dates

First Submitted

March 3, 2020

First Submitted That Met QC Criteria

March 6, 2020

First Posted (Actual)

March 10, 2020

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300004762

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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