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Improved Naloxone Access for Opioid Overdose (SAIA-N Trial)

N/A

Recruiting

Research Sponsored by RTI International

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 21 months

Awards & highlights

SAIA-N Trial Summary

This trial will compare a multi-faceted strategy to regular implementation of naloxone distribution to see if it improves # of doses and equitable distribution of naloxone.

Who is the study for?

This trial is for syringe service programs (SSPs) in California that are authorized by CDPH and have recently distributed naloxone. It's designed to improve how naloxone is given out to prevent opioid overdose deaths, focusing on reaching diverse populations including Black, Indigenous, and People of Color.Check my eligibility

What is being tested?

The study tests a new strategy called SAIA-N against the usual way SSPs give out naloxone. SAIA-N involves regular meetings with a coach to help optimize distribution over 12 months. The effectiveness will be measured by the number of doses and people reached, especially among BIPOC communities.See study design

What are the potential side effects?

Since this trial focuses on improving distribution methods rather than testing a new drug, it does not directly involve side effects related to medications or interventions.

SAIA-N Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~21 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cost (Aim 3) (Substance Abuse Services Cost Analysis Program (SASCAP))

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

Fidelity (Aim 1)

+3 more

SAIA-N Trial Design

2Treatment groups

Experimental Treatment

Group I: SAIA-NaloxoneExperimental Treatment1 Intervention

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.

Group II: Implementation as UsualExperimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

RTI InternationalLead Sponsor

189 Previous Clinical Trials

876,082 Total Patients Enrolled

Heluna HealthOTHER

University of California, San DiegoOTHER

1,122 Previous Clinical Trials

1,521,012 Total Patients Enrolled

Media Library

Naloxone Clinical Trial Eligibility Overview. Trial Name: NCT05886712 — N/A

Overdose Research Study Groups: Implementation as Usual, SAIA-Naloxone

Overdose Clinical Trial 2023: Naloxone Highlights & Side Effects. Trial Name: NCT05886712 — N/A

Naloxone 2023 Treatment Timeline for Medical Study. Trial Name: NCT05886712 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any participants currently being sought for this trial?

"According to clinicaltrials.gov, this particular medical trial is not actively seeking participants at the moment. Initially posted on June 4th of 2023 and last updated in May 23rd, though it may accept applicants again in the future - 30 other trials are presently enrolling patients now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Equitable Access to Naloxone to Prevent Opioid Overdose Deaths Within Syringe Service Programs (SAIA-Naloxone)

2023. "Improving Equitable Access to Naloxone to Prevent Opioid Overdose Deaths Within Syringe Service Programs (SAIA-Naloxone)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05886712.