NCT04303000

Increasing Naloxone Access for Persons Who Use Opioids

Completed Phase 4 Results posted Last updated 30 October 2023

What this trial tests

Phase 4 trial testing Opioid Overdose Education with Naloxone Distribution in Naloxone in 111 participants. Completed in 13 January 2022.

Timeline

11 July 2021

Primary endpoint
13 January 2022

13 January 2022

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	111
Start date	11 July 2021
Primary completion	13 January 2022
Estimated completion	13 January 2022
Sites	4 locations across United States

Drugs / interventions tested

• Opioid Overdose Education with Naloxone Distribution — full drug profile →
• Opioid Overdose Education — full drug profile →

Conditions studied

• Naloxone — all drugs for Naloxone →

Sponsor

University of Alabama at Birmingham

Who can join

18 and older, any sex, with Naloxone. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Number of Participants That Completed the Training in 6 Months Primary · 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.

Enrolled and Randomized

Group	Value	95% CI
Opioid Overdose Education and Naloxone Distribution	55
Opioid Overdose Education	56

Lost to Follow-up

Group	Value	95% CI
Opioid Overdose Education and Naloxone Distribution	10
Opioid Overdose Education	9

Change in Participant Knowledge of Opioid Overdose Response Procedures Primary · 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.

Group	Value	95% CI
Opioid Overdose Education and Naloxone Distribution	1.48	± 1.83
Opioid Overdose Education	1.34	± 1.51

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Preliminary effectiveness of online opioid overdose and naloxone administration training and impact of naloxone possession on opioid use.
   Sisson ML, Azuero A, Chichester KR, Carpenter MJ, et al · · 2023 · cited 5× · PMID 37336007 · DOI 10.1016/j.drugalcdep.2023.110815
2. Feasibility and acceptability of online opioid overdose education and naloxone distribution: Study protocol and preliminary results from a randomized pilot clinical trial.
   Sisson ML, Azuero A, Chichester KR, Carpenter MJ, et al · · 2023 · cited 4× · PMID 37091508 · DOI 10.1016/j.conctc.2023.101131