← Back to Search

Naloxone Navigator 1.0 for Opioid Addiction

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
18 years of age or greater prescribed chronic opioid therapy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights

Study Summary

This trial will test if a web-based "Naloxone Navigator 1.0" can help patients prescribed chronic opioid therapy (COT) to change their opioid risk behaviors and increase their knowledge about overdose and naloxone.

Eligible Conditions
  • Opioid Addiction
  • Overdose
  • Risky Behaviors

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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
Risk Behavior
Secondary outcome measures
Alcohol Use Risk Behavior
Drug Use Risk Behavior
Naloxone Dispensings
+2 more
Other outcome measures
Overdose
Pain Intensity

Side effects data

From 2017 Phase 4 trial • 570 Patients • NCT02032433
13%
Gastrointestinal
10%
Psychiatric
10%
Nervous system disorders
8%
Infections and infestations
6%
Injury, poisoning and procedural complications
6%
Injury poisoning and procedural complications
6%
Musculoskeletal and connective tissue disorders
4%
General Disorders and Administration Site Conditions
4%
Investigations
3%
Skin and subcutaneous tissue disorders
2%
Respiratory, thoracic, and mediastinal disorders
2%
Metabolism and nutrition
2%
Eye disorders
2%
Respiratory, thoracic and mediastinal disorders
1%
Renal and urinary disorders
1%
Reproductive system and breast disorders
1%
General disorders and administration site conditions
100%
80%
60%
40%
20%
0%
Study treatment Arm
Extended-Release Naltrexone
Buprenorphine-Naloxone

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Naloxone Navigator 1.0Experimental Treatment1 Intervention
Participants randomized to the Naloxone Navigator 1.0 arm will receive a link to the web-based resource. They will also receive usual care from their health plan, pharmacy and physicians. As part of usual care, participants will have access to naloxone through standing orders (i.e., they can request it without a prescription under their usual pharmacy benefit).
Group II: Usual CareActive Control1 Intervention
Participants in the usual care arm will receive usual care from their health plan, pharmacy and physicians. As part of usual care, participants will have access to naloxone through standing orders (i.e., they can request it without a prescription under their usual pharmacy benefit).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naloxone Navigator 1.0
2017
N/A
~330

Find a Location

Who is running the clinical trial?

Kaiser PermanenteLead Sponsor
538 Previous Clinical Trials
24,112,768 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,406 Total Patients Enrolled
5 Trials studying Opioid Addiction
648 Patients Enrolled for Opioid Addiction
Denver Health and Hospital AuthorityOTHER
101 Previous Clinical Trials
400,072 Total Patients Enrolled

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
Kentucky
North Carolina
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Impact of Direct Outreach to Expand Access to Naloxone in the Context of Standing Orders
2017. "Impact of Direct Outreach to Expand Access to Naloxone in the Context of Standing Orders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03241771.
~42 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top