Active — Not RecruitingNot Applicable

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

United States31 participantsStarted 2023-07-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * SSP is located and operates in California; SSP is authorized by CDPH; and SSP has distributed naloxone to participants in the past 30 days. Exclusion Criteria: * SSPs who participated in the SAIA-Naloxone pilot study (n = 2) or do not distribute naloxone (currently n = 0)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reach (Aim 1)

Timeframe: 21 months

Fidelity (Aim 1)

Timeframe: 21 months

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

Timeframe: 18 months

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

Timeframe: 18 months

Trial details

NCT IDNCT05886712

SponsorRTI International

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

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