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Online Naloxone Education for Drug Overdose

N/A

Waitlist Available

Led By Jason Glanz, PhD

Research Sponsored by Kaiser Permanente

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 change from baseline to 4-6 months, and 8-12 months

Awards & highlights

Study Summary

This trial will study the effects of an online overdose prevention and naloxone intervention for patients prescribed chronic opioid therapy. Outcomes include changes in opioid risk behaviors, naloxone uptake, and knowledge about overdose and naloxone.

Who is the study for?

This trial is for adults over 18 who are on long-term opioid medication and have a health plan covering naloxone, which can reverse overdoses. They must be able to access the internet and speak English. It's not for those in hospice care or with do-not-resuscitate orders.Check my eligibility

What is being tested?

The study tests a web-based program called Naloxone Navigator (NN) designed to prevent drug overdose among patients taking opioids regularly. It measures if NN changes their risk behaviors, increases naloxone use, and improves knowledge about overdoses.See study design

What are the potential side effects?

Since this trial focuses on an educational web intervention rather than a drug, there are no direct side effects from medications being tested. However, participants may experience distress or anxiety when learning about overdose risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 4-6 months, and 8-12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 4-6 months, and 8-12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 4-6 months, and 8-12 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

Change in Opioid-Related Risk Behavior

Secondary outcome measures

Change in Drug Use Risk Behavior

Change in Hazardous Drinking and Alcohol Use Disorders

Change in opioid dose

+3 more

Other outcome measures

Change in Pain Intensity

Rate of Aberrant Urine Toxicology Screens

Rate of Opioid Overdose

Side effects data

From 2017 Phase 4 trial • 570 Patients • NCT02032433

13%

Gastrointestinal

10%

Psychiatric

10%

Nervous system disorders

Infections and infestations

Injury, poisoning and procedural complications

Injury poisoning and procedural complications

Musculoskeletal and connective tissue disorders

General Disorders and Administration Site Conditions

Investigations

Skin and subcutaneous tissue disorders

Respiratory, thoracic, and mediastinal disorders

Metabolism and nutrition

Eye disorders

Respiratory, thoracic and mediastinal disorders

Renal and urinary disorders

Reproductive system and breast disorders

General disorders and administration site conditions

100%

80%

60%

40%

20%

Study treatment Arm

Extended-Release Naltrexone

Buprenorphine-Naloxone

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Naloxone NavigatorExperimental Treatment1 Intervention

Targeted, web-based animated video (Naloxone Navigator [NN]): This arm is a web-based intervention targeted to patients receiving chronic opioid therapy identified in the electronic health record. Participants in this arm have access to naloxone under standing orders from the pharmacy or with a prescription from their providers.

Group II: Usual CareActive Control1 Intervention

Participants in the usual care arm will receive usual care from their health plan, pharmacy and clinicians. As part of usual care, participants can access naloxone through physician prescription or standing orders.

Do I qualify?Apply below to find out