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

NCT03337100 | Completed DMC

• 2 other identifiers: CO-16-2405-021R01DA042059
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overdose; Risk Behavior

Keywords

Opioids; Naloxone; Co-dispensing; Cluster randomized trial; Opioid antagonist

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (6)

• Overdose and Naloxone Knowledge

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

• Rate of Naloxone Dispensings

  Baseline up to 2.5 years

• Patient reported naloxone pick-up

  Baseline up to 10 months

• Changes in opioid dose

  Baseline up to 2.5 years

• Change in Drug Use Risk Behavior

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

Other Outcomes (3)

• Change in Pain Intensity

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

• Rate of Opioid Overdose

  Baseline up to 2.5 years

• Rate of Aberrant Urine Toxicology Screens

  Baseline up to 2.5 years

Study Arms (2)

Co-Dispensing

EXPERIMENTAL

Early 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.

Behavioral: Co-Dispensing

Usual Care

NO INTERVENTION

Usual 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.

Interventions

Co-Dispensing BEHAVIORAL

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.

Co-Dispensing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Kaiser Permanente: lead
• Denver Health and Hospital Authority: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Denver Health

Denver, Colorado, 80204, United States

Location

Related Publications (1)

• 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.

  PMID: 35132556 DERIVED

MeSH Terms

Conditions

Drug Overdose; Risk-Taking

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Jason Glanz, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

• Ingrid Binswanger, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: November 8, 2017
• Study Start: November 27, 2017
• Primary Completion: April 30, 2021
• Study Completion: September 30, 2022
• Last Updated: March 3, 2023

Record last verified: 2023-03

Locations

US (1)