Improving Access to Naloxone to Prevent Opioid Overdose Deaths (SAIA-Naloxone)
NCT05886712 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2025-05-18
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
Interventions
- OTHER
-
Naloxone
Naloxone
- OTHER
-
Usual intervention
usual administered drug for overdose
Sponsors & Collaborators
-
University of California, San Diego
collaborator OTHER -
Heluna Health
collaborator OTHER -
RTI International
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-07-01
- Primary Completion
- 2026-04-30
- Completion
- 2026-06-30
Countries
- United States
Study Locations
More Related Trials
-
Naloxone Treatment in Skåne County - Effect on Drug-related Mortality and Overdose-related Complications
NCT03570099 ·Status: UNKNOWN
-
Pharmacokinetic Evaluation of a New Naloxone Nasal Swab, Naloxone Nasal Spray, and Intramuscular Naloxone Injection in Healthy Volunteers
NCT05363501 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Compare Bioavailability of Naloxone Nasal Spray and Naloxone Hydrochloride (HCl) Intramuscular Injection (IM) in Healthy Volunteers
NCT03827629 ·Status: COMPLETED ·Phase: PHASE1
-
A Usability Assessment of Naloxone by Community Members
NCT03309449 ·Status: COMPLETED ·Phase: NA
-
The Impact of a Web-Based Naloxone Intervention Under Standing Orders to Patients Prescribed Chronic Opioid Therapy
NCT03337009 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Nalmefene vs Naloxone for the Treatment of Recurrent Respiratory Depression After Opioid Overdose
NCT06408714 ·Status: WITHDRAWN ·Phase: PHASE3
-
Overdose Risk Management and Naloxone
NCT03933345 ·Status: UNKNOWN
-
A Study to Compare Bioavailability of Naloxone Nasal Spray, Naloxone Hydrochloride (HCl) Intravenous (IV) and Intramuscular Injection (IM) in Healthy Volunteers
NCT03827642 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Outcomes From Nalmefene
NCT05808881 ·Status: WITHDRAWN ·Phase: PHASE4
-
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1 - 1
NCT00000326 ·Status: WITHDRAWN ·Phase: PHASE2
-
Randomized Trial of Intranasal Versus Intravenous Naloxone in Level of Consciousness in Suspected Opioid Overdose
NCT01293058 ·Status: COMPLETED ·Phase: PHASE2
-
Increasing Patient Knowledge of the Signs of Opioid Overdose and Naloxone in a Suburban Treatment Program
NCT02120612 ·Status: COMPLETED
-
Increasing Naloxone Access for Persons Who Use Opioids
NCT04303000 ·Status: COMPLETED ·Phase: PHASE4
-
Long-Acting Injectable Naltrexone Treatment of Alcohol Dependence in Primary Care vs. in Specialized Chemical Dependence Treatment: A Pilot Trial
NCT00461890 ·Status: TERMINATED ·Phase: PHASE4
-
Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers
NCT02572089 ·Status: COMPLETED ·Phase: PHASE1
-
Blood Naloxone Levels Following Intradermal Injection in Humans
NCT05876572 ·Status: WITHDRAWN ·Phase: PHASE4
-
Blockade Efficacy of Buprenorphine/Naloxone For Opioid Dependence
NCT00134888 ·Status: COMPLETED ·Phase: NA
-
Assessing Abuse Potential of Parenteral Buprenorphine/Naloxone in Non-Dependent Opioid Abusers
NCT00134875 ·Status: TERMINATED ·Phase: NA
-
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2) - 2
NCT00000327 ·Status: WITHDRAWN ·Phase: PHASE2
-
Buprenorphine Naltrexone-P1 A-Cocaine
NCT00733720 ·Status: COMPLETED ·Phase: PHASE1
-
Naloxone SR Capsules in Patients With Opioid Induced Constipation
NCT00984334 ·Status: COMPLETED ·Phase: PHASE2
-
Comparison of Naloxone Pharmacokinetics
NCT03386591 ·Status: COMPLETED ·Phase: PHASE1
-
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-3 - 6
NCT00000331 ·Status: WITHDRAWN ·Phase: PHASE2
-
Evaluation of Intranasal Naltrexone and Naloxone
NCT03851731 ·Status: COMPLETED ·Phase: PHASE1
-
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment III) - 3
NCT00000328 ·Status: WITHDRAWN ·Phase: PHASE2