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Improving Access to Naloxone to Prevent Opioid Overdose Deaths (SAIA-Naloxone)

Study acronym: SAIA-N
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later Apr 30, 2026 → Jun 30, 2027
See other at-risk trials from RTI International

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Apr 30, 2026 to Jun 30, 2027
    • Study completion pushed from Jun 30, 2026 to Jun 30, 2027
    v6
  2. Primary endpoints: 6 to 4v5 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 32 to confirmed 31
    • Study description shortened, about 112 words
    • Site details revised
    • Study title shortened, about 5 words
  3. Primary completion date: Dec 31, 2023 to Apr 30, 2026v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study completion date: Dec 31, 2025 to Jun 30, 2026
    • Start date changed from estimate of Jun 4, 2023 to Jul 1, 2023
    • Site details revised
    v3
  5. Eligibility criteria revisedv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to compare the effectiveness of a multi-faceted implementation strategy, the Systems Analysis and Improvement Approach for Naloxone (SAIA-N), in syringe service programs (SSPs). The main questions it aims to answer are: * Does SAIA-N improve naloxone distribution (number of doses, number of people receiving naloxone) compared to implementation as usual (IAU)? * What are the costs associated with SAIA-N and how cost-effective is the strategy? SSPs randomized to the SAIA-N arm will participate in the strategy for a period of 12-months during which they will meet 1-2 times each month with a SAIA coach who will assist the SSP in optimizing their naloxone distribution. Researchers will compare SAIA-N to IAU to see if naloxone distribution and costs and cost-effectiveness differ by group.
Trial Details
NCT Number NCT05886712
Lead Sponsor RTI International
Collaborators: University of California, San Diego, Heluna Health
Conditions
(from sponsor)		 Overdose, Implementation as Usual
Related terms Drug Overdose
Enrollment 31 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov