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Phase 4 Completed N=319 Randomized Other

Increasing Naloxone Access for Persons Who Use Opioids

Naloxone
Source: ClinicalTrials.gov NCT04303000 ↗
Enrolled (actual)
319
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: The Number of Participants That Completed the Training in 6 Months — 55; 56; 10; 9 Participants
◆ Published Evidence
Emerging
6citations · ~2 / year
Preliminary effectiveness of online opioid overdose and naloxone administration training and impact of naloxone possession on opioid use.
Drug and alcohol dependence · 2023 · Likely link

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.

Linked Publications (3)

  • Preliminary effectiveness of online opioid overdose and naloxone administration training and impact of naloxone possession on opioid use.
    Drug and alcohol dependence · 2023 · 6 citations · Likely link
  • Feasibility and acceptability of online opioid overdose education and naloxone distribution: Study protocol and preliminary results from a randomized pilot clinical trial.
    Contemporary clinical trials communications · 2023 · 6 citations · Open access · Likely link
  • Characterizing Individuals Who Elect and Decline Opioid Overdose Education and Naloxone Distribution to Tailor Programs and Expand Impact.
    Journal of addiction medicine · 2025 · 0 citations · Likely link

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04303000) and the linked publication. 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. Informational only — not medical advice.

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