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OverdoseNCT03337100

The Impact of Co-Dispensing Naloxone to Patients Prescribed Chronic Opioid Therapy

A study testing Co-Dispensing in people with Overdose and Risk Behavior, run by Kaiser Permanente at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In the setting of naloxone standing orders, this study will assess if co-dispensing naloxone with opioids to patients prescribed chronic opioid therapy 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
Overdose, Risk Behavior
What is being tested?
Co-Dispensing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
27 Nov 2017to 30 Sep 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

  • Stock naloxone for outpatient dispensing.
  • Pharmacy leadership willing to provide naloxone under a co-dispensing protocol.
  • Pharmacy leadership willing to be randomized to order of implementation.
  • Have or can implement a naloxone standing order.
  • Prescribed chronic opioid therapy and meet criteria for the pharmacy co-dispensing protocol
  • Receive medications at participating pharmacies
  • Have a health plan which covers the formulation of naloxone available at the pharmacy they received their opioid prescriptions from.
  • (for surveys)18 years of age or greater

Who cannot join

  • None
  • (for surveys) Non-English speaking, hospice enrollment, do-not-resuscitate order

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Denver Health

    Denver, Colorado, 80204

Other trials in United States

About this study

In the setting of naloxone standing orders, this study will assess if co-dispensing naloxone with opioids to patients prescribed chronic opioid therapy changes opioid risk behaviors, increases naloxone uptake, and increases knowledge about overdose and naloxone.

Read the detailed description

This is a pragmatic, pharmacy-based, cluster randomized controlled trial of a naloxone co-dispensing program for adults prescribed chronic opioid therapy. Pharmacies (target N=6) will be randomized to the order in which they are encouraged to implement a naloxone co-dispensing program for patients prescribed chronic opioid therapy. The intent of this program is to provide patients prescribed chronic opioid therapy naloxone for potential opioid overdose reversal under the terms of a standing order. Participants prescribed chronic opioid therapy who use randomized pharmacies will be recruited to receive knowledge and risk surveys at baseline and over the follow-up. The primary outcome is opioid risk behaviors (target enrollment is 200 patients). Secondary outcomes include knowledge about overdose and naloxone, substance use, and pain intensity. Patients who use randomized pharmacies (anticipated n=550 patients) will also be followed in the electronic health record for secondary outcomes: naloxone dispensings, changes in opioid dose, aberrant urine toxicology results, and overdose events.

Being tested
Co-Dispensing
Keywords
Opioids, Naloxone, Co-dispensing, Cluster randomized trial, Opioid antagonist
Medical subject headings
Drug Overdose, Risk-Taking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Co-DispensingBehavioural

    Implementation of a naloxone co-dispensing pharmacy program.

    The intent of this program is to provide patients prescribed chronic opioid therapy naloxone under the terms of a standing order for potential opioid overdose reversal. Prior to implementing the program, a naloxone standing order will be implemented and pharmacy operational staff will provide training to pharmacy staff about the standing order and a naloxone co-dispensing protocol. Under a co-dispensing protocol, pharmacy staff members will identify opioid prescriptions meeting criteria for co-dispensing, prepare naloxone fills, offer patients naloxone, and provide counseling on its use.

Study groups in NCT03337100
Study groupRoleWhat they receive
Co-DispensingExperimentalEarly implementation of a naloxone co-dispensing pharmacy program. Pharmacies in the phase 1 (early) naloxone co-dispensing arm will be assigned to implement the pharmacy based naloxone co-dispensing program first relative to the phase 2 arm.
Receives: Behavioral: Co-Dispensing
Usual CareNo interventionUsual care/Phase 2 naloxone co-dispensing: Pharmacies in the usual care/phase 2 naloxone co-dispensing arm will provide usual pharmacy services to patients receiving chronic opioid therapy (no naloxone co-dispensing). After 10 months, they may implement the pharmacy-based naloxone co-dispensing program.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Opioid-Related Risk Behavior

    Among survey participants, risk behavior will be assessed using the Opioid-Related Behaviors in Treatment (ORBIT) scale. The ORBIT is a scale used to identify recent risk behavior among patients receiving chronic opioid therapy. Scores on the single scale range from 0-40, with lower values representing less risk behavior.

    Measured: Change from baseline to 4-6 months and 8-10 months

Secondary outcomes (6)

  1. Overdose and Naloxone Knowledge

    Among survey participants, 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. The investigators have adapted it to be specific to prescription opioids. The modified-OOKS is scored on a scale of 0-28, with higher values representing greater knowledge about overdose and naloxone.

    Measured: Change from baseline to 4-6 months, and 8-10 months

  2. Rate of Naloxone Dispensings

    Among survey participants and participants followed using automated data only, pharmacy and insurance claims databases will be used to identify naloxone dispensings.

    Measured: Baseline up to 2.5 years

  3. Patient reported naloxone pick-up

    Among survey participants, surveys will be used to identify naloxone dispensings in the outpatient setting.

    Measured: Baseline up to 10 months

  4. Changes in opioid dose

    Among survey participants and participants followed using automated data only, changes in the milligrams morphine equivalent dose will be calculated from pharmacy and insurance claims databases.

    Measured: Baseline up to 2.5 years

  5. Change in Drug Use Risk Behavior

    Among survey participants, drug use risk behavior will be assessed using question 2 of the validated National Institutes on Drug Abuse-Modified Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) scale version 2.0. The investigators added an item about tobacco use from the WHO ASSIST V3.0 to the NIDA-modified ASSIST V2.0 instrument, resulting in a scale of 0-66, with lower values representing less drug use risk behavior.

    Measured: Change from baseline to 4-6 months and 8-10 months

  6. Change in Hazardous Drinking or Alcohol Use Disorders

    Among survey participants, alcohol use risk behavior will be assessed using the validated Alcohol Use Disorders Identification Test--Consumption (AUDIT-C) scale. The AUDIT-C is a screener used to identify patients with alcohol use disorders or hazardous drinking behavior. The AUDIT-C is scored on a scale of 0-12. The higher the score, the more likely it is that the patient's drinking is affecting his or her safety.

    Measured: Change from baseline to 4-6 months and 8-10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2017
  2. Study start27 Nov 2017
  3. Primary completion30 Apr 2021
  4. Study completion30 Sep 2022

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03337100
Sponsor's protocol ID
CO-16-2405-02
Other IDs
1R01DA042059
Status last verified
Mar 2023
First submitted
16 Oct 2017
Last updated
3 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Binswanger IA, Rinehart D, Mueller SR, Narwaney KJ, Stowell M, Wagner N, Xu S, Hanratty R, Blum J, McVaney K, Glanz JM. Naloxone Co-Dispensing with Opioids: a Cluster Randomized Pragmatic Trial. J Gen Intern Med. 2022 Aug;37(11):2624-2633. doi: 10.1007/s11606-021-07356-6. Epub 2022 Feb 7.

    PubMed 35132556

Questions about this trial

What is this clinical trial studying?

A study testing Co-Dispensing in people with Overdose and Risk Behavior, 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 8 inclusion and 2 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 3 Mar 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?

Change in Opioid-Related Risk Behavior (time frame: Change from baseline to 4-6 months and 8-10 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03337100, which also lists 1 linked publication.

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 3 Mar 2023.

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