Phase 4
N=319
Increasing Naloxone Access for Persons Who Use Opioids
Naloxone
Bottom Line
View on ClinicalTrials.gov: NCT04303000 ↗Enrolled (actual)
319
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: The Number of Participants That Completed the Training in 6 Months — 55; 56; 10; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Opioid Overdose Education with Naloxone Distribution (Drug); Opioid Overdose Education (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants That Completed the Training in 6 Months |
55; 56; 10; 9 | — |
| PRIMARY Change in Participant Knowledge of Opioid Overdose Response Procedures |
1.48; 1.34 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04303000). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.