Opioid AbuseNCT03241771
Impact of Direct Outreach to Expand Access to Naloxone in the Context of Standing Orders
A study testing Naloxone Navigator 1.0 in people with Opioid Abuse and Overdose, run by Kaiser Permanente at 1 site in United States.
Trial summary
In the setting of naloxone standing orders, this study will assess if direct outreach with a web-based "Naloxone Navigator 1.0" to patients prescribed chronic opioid therapy (COT) changes opioid risk behaviors, increases naloxone uptake, and increases knowledge about overdose and naloxone Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Abuse, Overdose, Risk Behavior
- What is being tested?
- Naloxone Navigator 1.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2017to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or greater prescribed chronic opioid therapy
Who cannot join
- Non-English speaking, hospice enrollment, do-not-resuscitate order, receipt of naloxone in the last 12 months, no internet access, not planning to continue to receive care in the same setting for the next 4 months.
Trial locations and contacts
1 site in 1 country.
About this study
In the setting of naloxone standing orders, this study will assess if direct outreach with a web-based "Naloxone Navigator 1.0" to patients prescribed chronic opioid therapy (COT) changes opioid risk behaviors, increases naloxone uptake, and increases knowledge about overdose and naloxone
Read the detailed description
This is a randomized study of a web-based naloxone educational resource (Naloxone Navigator 1.0) for adults prescribed chronic opioid therapy. This study will be conducted under new naloxone standing order legislation passed in Colorado. The Naloxone Navigator 1.0 will provide online training on how to recognize an opioid overdose and respond using naloxone. There will be two arms: one will receive a link to the Naloxone Navigator 1.0 and the other will receive usual care (no link). Outcomes will include opioid risk behavior, overdose and naloxone knowledge, naloxone dispensings, and overdose rates.
- Conditions
- Opioid Abuse, Overdose, Risk Behavior
- Being tested
- Naloxone Navigator 1.0
- Medical subject headings
- Opioid-Related Disorders, Drug Overdose, Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naloxone Navigator 1.0Behavioural
Also called Naloxone Navigator (NN)
Patients on chronic opioid therapy will be outreached via email, mail and phone. Within 1 month of enrollment into the trial, intervention participants will receive a link to the web-based resource to view. This is designed to provide overdose education, increase opioid risk awareness, and encourage patients to obtain naloxone.
| Study group | Role | What they receive |
|---|---|---|
| Naloxone Navigator 1.0 | Experimental | 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). Receives: Behavioral: Naloxone Navigator 1.0 |
| Usual Care | No 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk Behavior
Risk behavior will be assessed using the Opioid-Related Behaviors in Treatment (ORBIT) scale. The ORBIT is a brief scale used to identify recent risk behavior among patients receiving chronic opioid therapy.
Measured: 4 months
Secondary outcomes (5)
Patient Knowledge
Patient knowledge of overdose and naloxone will be measured using survey items adapted from the Opioid Overdose Knowledge Scale (OOKS). The OOKS is a scale measuring knowledge of overdose risks, warning signs, steps to address the overdose and appropriate use of naloxone.
Measured: Within 1 month of study enrollment
Naloxone Dispensings
Electronic health records and pharmacy databases will be used to identify naloxone dispensings in the outpatient setting.
Measured: 4 months
Opioid dose
We will calculate changes in the milligrams morphine equivalent dose
Measured: 4 months
Drug Use Risk Behavior
Drug Use Risk Behavior will be assessed using the validated National Institutes on Drug Abuse-Modified (ASSIST) scale.
Measured: 4 months
Alcohol Use Risk Behavior
Alcohol Use Risk Behavior will be assessed using the validated Alcohol Use Disorders Identification Test--Consumption (AUDIT-C Lite) scale. AUDIT-C Lite is a brief screener used to identify patients with alcohol use disorders or hazardous drinking behavior
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start14 Aug 2017
- Primary completion14 Aug 2018
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid AbuseStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Denver Health and Hospital Authority, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Ingrid Binswanger, MD, Principal investigator, Kaiser PermanenteJason Glanz, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241771
- Sponsor's protocol ID
- CO-16-2405
- Other IDs
- 1R01DA042059-01
- Status last verified
- Aug 2023
- First submitted
- 2 Aug 2017
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Direct Outreach to Expand Access to Naloxone in the Context of Standing Orders
- ClinicalTrials.gov ID
- NCT03241771
- Acronym / sponsor ID
- CO-16-2405
- Conditions
- Opioid Abuse, Overdose, Risk Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Denver Health and Hospital Authority, National Institute on Drug Abuse (NIDA)
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 14 Aug 2018 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 7 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the setting of naloxone standing orders, this study will assess if direct outreach with a web-based "Naloxone Navigator 1.0" to patients prescribed chronic opioid therapy (COT) changes opioid risk behaviors, increases naloxone uptake, and increases knowledge about overdose and naloxone
Detailed description
This is a randomized study of a web-based naloxone educational resource (Naloxone Navigator 1.0) for adults prescribed chronic opioid therapy. This study will be conducted under new naloxone standing order legislation passed in Colorado. The Naloxone Navigator 1.0 will provide online training on how to recognize an opioid overdose and respond using naloxone. There will be two arms: one will receive a link to the Naloxone Navigator 1.0 and the other will receive usual care (no link). Outcomes will include opioid risk behavior, overdose and naloxone knowledge, naloxone dispensings, and overdose rates.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naloxone Navigator 1.0 | Experimental | Behavioral: Naloxone Navigator 1.0Participants 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). |
| Usual Care | No 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years of age or greater prescribed chronic opioid therapy
Key exclusion criteria (1 listed)
- Non-English speaking, hospice enrollment, do-not-resuscitate order, receipt of naloxone in the last 12 months, no internet access, not planning to continue to receive care in the same setting for the next 4 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naloxone Navigator 1.0Also: Naloxone Navigator (NN)Patients on chronic opioid therapy will be outreached via email, mail and phone. Within 1 month of enrollment into the trial, intervention participants will receive a link to the web-based resource to view. This is designed to provide overdose education, increase opioid risk awareness, and encourage patients to obtain naloxone. | Behavioural | Naloxone Navigator 1.0 |
Primary outcome
Risk Behavior
Time frame: 4 months
Risk behavior will be assessed using the Opioid-Related Behaviors in Treatment (ORBIT) scale. The ORBIT is a brief scale used to identify recent risk behavior among patients receiving chronic opioid therapy.
5 secondary outcomes
Patient Knowledge
Time frame: Within 1 month of study enrollment
Naloxone Dispensings
Time frame: 4 months
Opioid dose
Time frame: 4 months
Drug Use Risk Behavior
Time frame: 4 months
Alcohol Use Risk Behavior
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Opioid Abuse
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Active, not recruitingObservational study
Cannabis Use and Outcomes in Black and White Patients With Cancer
Cancer
Active, not recruiting
The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care
Opioid Dependence, Substance Abuse Disorders
Recruiting
Improving Jail Response to the Overdose Crisis: A Hybrid Trial of Jail ECHO to Improve MOUD Implementation and Public Health Outcomes
Opioid Abuse (Disorder)
RecruitingPhase 4
Abuse Potential of Gabapentin Taken Orally Concomitantly With Oxycodone Hydrochloride in Healthy, Non-Drug-Dependent, Recreational Opioid Users
Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingrid Binswanger, MD principal investigator
Kaiser Permanente
Jason Glanz, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naloxone Navigator 1.0 in people with Opioid Abuse and Overdose, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk Behavior (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.