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

NCT05886712 | Active Not Recruiting

• 1 other identifier: 00021706
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overdose; Implementation as Usual

Outcome Measures

Primary Outcomes (4)

• Reach (Aim 1)

  Number of participants screened for naloxone engagement, while accounting for the total number of participants who present for services

  21 months

• Fidelity (Aim 1)

  Number of people who receive naloxone, while accounting for the total number of SSP participants screened for naloxone distribution

  21 months

• Cost (Aim 2) (Substance Abuse Services Cost Analysis Program (SASCAP))

  Dollar amount of cost estimates associated with SAIA-N at the SSP level

  18 months

• Cost-effectiveness (Incremental Cost-effectiveness Ratio (ICER))

  The ratio of the difference in costs to the difference in outcomes between study groups

  18 months

Study Arms (2)

SAIA-Naloxone

EXPERIMENTAL

SAIA-Naloxone is an intervention that facilitates an organizational SSP level analysis of naloxone delivery by assigning a trained SAIA-Naloxone coach to apply tools and techniques and engage staff to define barriers, identify solutions, and evaluate their success in cycles until achieving desired change regarding naloxone distribution. Coaches will meet with SSPs twice per month for the first 3 months and once per month for the remaining 9 months during the 12-month intervention period.

Other: Naloxone

Implementation as Usual

OTHER

SSPs randomized to the IAU arm will not receive support to improve naloxone distribution. SSPs in California have already adopted naloxone distribution. The investigators are therefore testing the ability of SAIA-Naloxone to optimize naloxone distribution within SSPs. Accordingly, IAU is characterized by the absence of SAIA-Naloxone with the goal of comparing whether SAIA-Naloxone improves SSPs' Naloxone distribution.

Other: Usual intervention

Interventions

Naloxone OTHER

Naloxone

SAIA-Naloxone

Usual intervention OTHER

usual administered drug for overdose

Implementation as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SSP is located and operates in California; SSP is authorized by CDPH; and SSP has distributed naloxone to participants in the past 30 days.

You may not qualify if:

• SSPs who participated in the SAIA-Naloxone pilot study (n = 2) or do not distribute naloxone (currently n = 0)

Sponsors & Collaborators

• RTI International: lead
• University of California, San Diego: collaborator
• Heluna Health: collaborator

Study Sites (1)

RTI International

Berkeley, California, 94704, United States

Location

MeSH Terms

Conditions

Drug Overdose

Interventions

Naloxone

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: June 2, 2023
• Study Start: July 1, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)