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Online Naloxone Education for Drug Overdose
N/A
Waitlist Available
Led By Ingrid Binswanger, MD
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
No Placebo-Only Group
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.
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.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Opioid-Related Risk Behavior
Secondary study objectives
Change in Drug Use Risk Behavior
Change in Hazardous Drinking and Alcohol Use Disorders
Change in opioid dose
+3 moreOther study objectives
Change in Pain Intensity
Rate of Aberrant Urine Toxicology Screens
Rate of Opioid Overdose
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Who is running the clinical trial?
Kaiser PermanenteLead Sponsor
552 Previous Clinical Trials
27,730,618 Total Patients Enrolled
3 Trials studying Overdose
346 Patients Enrolled for Overdose
National Institute on Drug Abuse (NIDA)NIH
2,586 Previous Clinical Trials
3,327,526 Total Patients Enrolled
5 Trials studying Overdose
1,991 Patients Enrolled for Overdose
Ingrid Binswanger, MDPrincipal InvestigatorKaiser Permanente
2 Previous Clinical Trials
332 Total Patients Enrolled
2 Trials studying Overdose
332 Patients Enrolled for Overdose
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking chronic opioid medication as part of your treatment plan.You have an order that says you do not want to be resuscitated in case of a medical emergency.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: Naloxone Navigator
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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