Increasing Naloxone Access for Persons Who Use Opioids

Phase 4

Completed

• Conditions: Naloxone
• Interventions: Drug: Opioid Overdose Education with Naloxone Distribution; Drug: Opioid Overdose Education

• Registration Number: NCT04303000
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-06
• Study First Posted: 2020-03-10
• Study Start: 2021-07-11
• Primary Completion: 2022-01-13
• Study Completion: 2022-01-13
• Results First Submitted: 2022-09-25
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-27
• Last Update Submitted: 2023-10-27
• Results First Posted: 2023-10-30
• Last Update Posted: 2023-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid Overdose Education and Naloxone Distribution	Opioid Overdose Education with 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).
Opioid Overdose Education	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.

Primary Outcome Measures

Name	Time	Method
The Number of Participants That Completed the Training in 6 Months	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.
Change in Participant Knowledge of Opioid Overdose Response Procedures	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.

Trial Locations

Locations (1)

Craigslist; 🇺🇸 Montgomery, Alabama, United States