Increasing Naloxone Access for Persons Who Use Opioids
1 other identifier
interventional
111
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2021
Shorter than P25 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2020
CompletedFirst Posted
Study publicly available on registry
March 10, 2020
CompletedStudy Start
First participant enrolled
July 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2022
CompletedResults Posted
Study results publicly available
October 30, 2023
CompletedOctober 30, 2023
October 1, 2023
6 months
March 3, 2020
September 25, 2022
October 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The Number of Participants That Completed the Training in 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
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
Study Arms (2)
Opioid Overdose Education and Naloxone Distribution
EXPERIMENTALParticipants 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
ACTIVE COMPARATORParticipants 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.
Interventions
Online audiovisual training focused on recognizing the signs of an opioid overdose and administering naloxone. Participants are provided with a naloxone kit.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Contraindication for naloxone (known severe allergic reaction)
- Cognitive impairment or unstable psychiatric condition that interferes with the informed consent process
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Craigslist
Anniston, Alabama, 36201, United States
Craigslist
Gadsden, Alabama, 35901, United States
Craigslist
Mobile, Alabama, 36695, United States
Craigslist
Montgomery, Alabama, 36117, United States
Related Publications (3)
Sisson ML, Azuero A, Hawes E, Chichester KR, Carpenter MJ, Businelle MS, Shelton RC, Cropsey KL. Characterizing Individuals Who Elect and Decline Opioid Overdose Education and Naloxone Distribution to Tailor Programs and Expand Impact. J Addict Med. 2025 May-Jun 01;19(3):268-273. doi: 10.1097/ADM.0000000000001407. Epub 2024 Nov 8.
PMID: 39514898DERIVEDSisson ML, Azuero A, Chichester KR, Carpenter MJ, Businelle MS, Shelton RC, Cropsey KL. Preliminary effectiveness of online opioid overdose and naloxone administration training and impact of naloxone possession on opioid use. Drug Alcohol Depend. 2023 Aug 1;249:110815. doi: 10.1016/j.drugalcdep.2023.110815. Epub 2023 Jun 7.
PMID: 37336007DERIVEDSisson ML, Azuero A, Chichester KR, Carpenter MJ, Businelle MS, Shelton RC, Cropsey KL. Feasibility and acceptability of online opioid overdose education and naloxone distribution: Study protocol and preliminary results from a randomized pilot clinical trial. Contemp Clin Trials Commun. 2023 Apr 5;33:101131. doi: 10.1016/j.conctc.2023.101131. eCollection 2023 Jun.
PMID: 37091508DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Melinda Clarke
- Organization
- University of Alabama at Birmingham
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle Sisson, MA
University of Alabama at Birmingham
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctoral Student
Study Record Dates
First Submitted
March 3, 2020
First Posted
March 10, 2020
Study Start
July 11, 2021
Primary Completion
January 13, 2022
Study Completion
January 13, 2022
Last Updated
October 30, 2023
Results First Posted
October 30, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share