MedTrace Logo

RESPOND TO PREVENT: Stepwise Pharmacy Naloxone Study

NCT03545321 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2022-03-02

No results posted yet for this study

Summary

This multi-site study will test the efficacy of an intervention to train and equip pharmacists to provide naloxone, an overdose antidote, to patients using prescribed and illicit opioids, to improve opioid safety and prevent opioid-involved adverse events. The study will carry out a stepped-wedge, cluster randomized trial implemented over five waves, within two chain community pharmacies across four states with varying pharmacy-based naloxone distribution laws: Oregon, Washington, Massachusetts, and New Hampshire. Our specific study aims are to: 1) integrate two successful demonstration research projects into one cohesive educational program (MOON+), 2) evaluate the effectiveness of MOON + on naloxone-related outcomes, and 3) use mixed methods to further explore the impact and implementation of MOON+ and associated factors (e.g., state policy, store policy, region).

Conditions

  • Pharmacies
  • Opioid Use
  • Patient Safety

Interventions

BEHAVIORAL

MOON+

MOON+ is an intervention to support the pharmacy and pharmacist to improve opioid safety and naloxone provision. Materials include educational trainings, materials for use with pharmacists, information for patients, and materials for standardizing overdose safety at the pharmacy

Sponsors & Collaborators

  • Comagine Health

    collaborator OTHER

  • Oregon Health and Science University

    collaborator OTHER

  • University of Rhode Island

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Brandeis University

    lead OTHER

Principal Investigators

  • Traci C Green, PhD, MSc · Brandeis University

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-09
Primary Completion
2022-11-30
Completion
2022-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03545321 on ClinicalTrials.gov