Study protocol for the Respond to Prevent Study: a multi-state randomized controlled trial to improve provision of naloxone, buprenorphine and nonprescription syringes in community pharmacies

Abstract

Access to the opioid antidote naloxone is a critical component of addressing the opioid crisis. Naloxone is a population-level prevention intervention associated with substantial reductions in overdose mortality and reduction of nonfatal overdose. Pharmacies’ pivotal role in dispensing medications like buprenorphine for the treatment of opioid use disorder and selling nonprescription syringes places them at the crossroads of opioid access and risk mitigation methods like naloxone provision. Testing ways to optimize pharmacy-based naloxone provision will be key as the country expands the implementation of naloxone through the medical system. In the Respond to Prevent Study, we conducted a large, practical study of a pharmacy-focused intervention in a sample of Washington, Oregon, Massachusetts and New Hampshire community chain pharmacies to increase naloxone dispensing and improve opioid safety. The intervention integrated two evidence-based educational toolkits and streamlined materials to enhance the focus on naloxone policy, stigma reduction, and patient communications around naloxone, nonprescription syringes and buprenorphine access. The real-world study implemented a stepped wedge, clustered randomized trial design across 175 community chain pharmacies to evaluate the effectiveness of the Respond to Prevent intervention in increasing: (a) pharmacy based naloxone distribution rates, naloxone-related patient engagement, and pharmacist and technicians’ attitudes, knowledge, perceived behavioral control and self-efficacy toward naloxone; and (b) pharmacy nonprescription syringe sales, and pharmacist and technicians’ attitudes, knowledge, perceived behavioral control and self-efficacy toward dispensing buprenorphine for opioid use disorder (secondary outcomes). This commentary provides a brief narrative about the study and presents insights on the design and adaptations to our study protocol, including those adopted during the unprecedented COVID-19 pandemic further compounded by Western wildfires in 2020.

Keywords:

• Overdose
• pharmacy
• naloxone
• stepped-wedge design
• buprenorphine
• stigma

Acknowledgements

We are grateful for the administrative supports of Gail Hall and manuscript submission support from Diana Paola Flores.

Disclosure statement

None of the authors report a conflict of interest. The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the funder or their academic institutions.

Author contributions

TCG conceived of the protocol, acquired the funding, oversaw the implementation, and prepared the initial draft. JDB and DH contributed to conceptualization of the protocol and acquiring the funding, as well as to writing and review of the manuscript. ANI, MG, JB, AF, DB, ZA, and RH contributed to conceptualization and adaptations of the protocol, analysis for the narrative, and writing and review of the manuscript. GL and JA supported adaptations to the protocol, project administration, and reviewed the manuscript.

Additional information

Funding

Funding from the National Institutes of Health, National Institute of Drug Abuse [NIDA R01DA045745 PI: Green] supported this research. The funder had no further role in the study design; in the collection, analysis and interpretation of data; in the writing of the manuscript; or in the decision to submit the paper for publication.