Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04303000 |
| Other study ID # |
IRB-300004762 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
July 11, 2021 |
| Est. completion date |
January 13, 2022 |
Study information
| Verified date |
October 2023 |
| Source |
University of Alabama at Birmingham |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
