Naloxone Communication Training for Pharmacists

(Nalox-Comm Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Non-staff pharmacists

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to help pharmacists communicate more effectively about naloxone, a medication that can reverse opioid overdoses. It compares two online training modules: the Nalox-comm Training Module, which covers basic naloxone information, and Prescribe to Prevent: Overdose Prevention and Naloxone Rescue Kits for Prescribers and Pharmacists, which teaches how to overcome communication barriers. Pharmacists working in rural community pharmacies that stock naloxone and speak English might be suitable for this trial. The goal is to improve how naloxone is dispensed and used, ultimately helping to prevent overdoses. As an unphased trial, this study offers pharmacists the chance to enhance their communication skills and contribute to overdose prevention efforts.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that naloxone communication training, such as the Nalox-Comm module, is generally safe. Although formal safety studies in non-medical settings are lacking, it is expected to be as safe as in medical environments. No reports of serious side effects have emerged from this type of training. The module is an online course designed to help pharmacists communicate about naloxone, a drug used to reverse opioid overdoses. Since it focuses on communication skills, it poses no direct health risks to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nalox-Comm training module because it addresses communication barriers that pharmacists face when discussing naloxone with patients. Unlike standard training, which often just provides basic information about naloxone, Nalox-Comm is specifically designed to empower pharmacists with the skills to effectively communicate the importance of naloxone in preventing overdoses. This targeted approach could lead to better patient outcomes by increasing the accessibility and acceptance of naloxone rescue kits, ultimately helping to save more lives.

What evidence suggests that this trial's treatments could be effective for naloxone dispensing?

Research has shown that teaching people how to use naloxone can greatly improve outcomes for those experiencing opioid overdoses. For instance, one study found that a community naloxone program saved 172 lives, even as opioids became stronger. Another study with over 74,000 participants demonstrated that distributing naloxone effectively prevented deaths from overdoses. Short training sessions have increased people's knowledge and confidence in using naloxone, suggesting that training pharmacists could have a similar effect.

In this trial, participants will engage with one of two educational programs: the "Prescribe to Prevent Naloxone Training Module," which covers basic information about naloxone for community pharmacists, or the "Nalox-Comm" module, which focuses on overcoming communication barriers related to naloxone. These findings suggest that training pharmacists to communicate about naloxone could enhance their ability to provide it, potentially saving more lives. ^{1 6 7 8 9}

Who Is on the Research Team?

Delesha Carpenter, PhD, MSPH

Principal Investigator

UNC Eshelman School of Pharmacy

Are You a Good Fit for This Trial?

Inclusion Criteria

All Ingles pharmacist stock naloxone

Exclusion Criteria

Non-staff pharmacists such as pharmacy "floaters" or fill-in pharmacists will not be eligible to participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Pharmacists undergo naloxone communication training through online modules

1 week

Online module

Data Collection

Data on naloxone dispensing and secondary outcomes are collected

3 months

Follow-up

Participants are monitored for changes in naloxone dispensing rates and willingness to dispense naloxone

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Nalox-comm Training Module
• Prescribe to Prevent: Overdose Prevention and Naloxone Rescue Kits for Prescribers and Pharmacists

How Is the Trial Designed?

Group I: Nalox-Comm Experimental Treatment 1 Intervention

This is a newly developed 30-60 minute online module focused on teaching pharmacists how to overcome naloxone communication barriers.

Group II: Prescribe to Prevent Naloxone Training Module Placebo Group 1 Intervention

This a 55-minute online module that covers basic information about naloxone that is relevant to community pharmacists.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Naloxone is a safe and effective antidote for opioid overdose, with a long history of use by healthcare professionals, and expanding access to it for high-risk individuals and their families is a key public health initiative.

While naloxone is generally safe, its administration can lead to varying levels of adverse reactions, especially with higher doses or intravenous use, highlighting the importance of training for non-healthcare professionals in recognizing overdoses and administering naloxone correctly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of naloxone safety for opioid overdose: practical considerations for new technology and expanded public access. Wermeling, DP.[2020]

A state-wide naloxone distribution program in West Virginia successfully distributed 8,250 rescue kits, highlighting the importance of collaborative partnerships and community demand for naloxone as key facilitators in reducing opioid overdose deaths.

Despite facing barriers such as organizational bureaucracy and stigma, the overall positive impact of the program suggests that effective implementation strategies can overcome these challenges, providing valuable insights for future large-scale naloxone distribution efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitators, barriers and lessons learnt from the first state-wide naloxone distribution conducted in West Virginia. Rudisill, TM., Ashraf, AJ., Linn, HI., et al.[2022]

In a survey of 458 people who inject drugs in San Francisco, 62.9% reported receiving overdose response training, and 68.8% owned a naloxone kit, indicating a significant level of preparedness to respond to opioid overdoses.

However, there are disparities in training access, as non-white individuals were less likely to receive overdose response training compared to white individuals, highlighting the need for targeted outreach to improve naloxone use among diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and disparities in opioid overdose response training among people who inject drugs, San Francisco: Naloxone training among injectors in San Francisco. Kim, K., Oh, H., Miller, D., et al.[2021]

From 1996 to June 2014, organizations distributed naloxone kits to over 152,000 laypersons, leading to 26,463 reported overdose reversals, highlighting the effectiveness of community-based opioid overdose prevention programs.

The training and provision of naloxone to bystanders can significantly reduce opioid overdose deaths, addressing a critical public health issue as drug overdose deaths have more than doubled since 1999.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid Overdose Prevention Programs Providing Naloxone to Laypersons - United States, 2014. Wheeler, E., Jones, TS., Gilbert, MK., et al.[2022]

Community-based overdose education and naloxone distribution (OEND) programs have shown effectiveness in training individuals to prevent opioid overdoses and administer naloxone, which is crucial for saving lives.

Translating OEND into conventional medical settings, where physicians can counsel patients on opioid overdose risks and prescribe naloxone, is an emerging practice that may significantly reduce overdose fatalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Opioid Overdose Prevention and Naloxone Prescribing: Implications for Translating Community Programming Into Clinical Practice. Mueller, SR., Walley, AY., Calcaterra, SL., et al.[2018]

Training baccalaureate nursing students on opioids and naloxone significantly improved their knowledge, skills, and confidence in responding to opioid overdoses, as shown by data from 284 students.

The positive impact of the training was sustained over time, with slight enhancements in knowledge and skills observed one week after the training, indicating its effectiveness across different semesters of the nursing program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Opioid Education Program for Baccalaureate Nursing Students. Hines, CB., Cody, SL., Eyer, JC., et al.[2021]

Training healthcare professionals in managing opioid overdoses and administering naloxone significantly improved their knowledge and confidence, with scores increasing from an average of 18.3 to 21.2 out of 26 after training.

While the 'cascade method' of training was somewhat effective, challenges such as clinician time constraints and resource availability hindered broader implementation, highlighting the need for policy changes and enhanced educational programs in drug services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of training for healthcare professionals on how to manage an opioid overdose with naloxone: effective, but dissemination is challenging. Mayet, S., Manning, V., Williams, A., et al.[2015]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12140937/

Reported outcomes from a community naloxone training ...

Even as opioids were becoming more potent with fentanyl, we know that 172 lives were saved by naloxone distributed from our program. Further, ...

2.

bmcpublichealth.biomedcentral.com

bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-025-22210-8

Effectiveness of naloxone distribution in community settings to ...

The 41 studies reported individual-level data on 74,114 study participants, who reported outcomes (survival or death) after 10,328 naloxone ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04677387

Study Details | NCT04677387 | Nalox-Comm: Naloxone ...

Data will be collected at baseline, immediately after training is completed, and at 3-month follow up. Data sources include pharmacy records (for naloxone ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2772628223000766

Exploring the impact of brief training on student ...

Brief written or video-based naloxone training improved students' knowledge, self-efficacy, and communication. Given the small sample, results ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8697700/

A Study on the Efficacy of a Naloxone Training Program

Conclusion: The educational training on opioids, opioid overdose, and the use of naloxone was an effective adjunct to naloxone kit distribution ...

6.

overdoselifeline.org

overdoselifeline.org/opioid-training-and-courses/layperson-naloxone-administration/

Naloxone (NARCAN) Training Course and Trainer Program

Layperson Naloxone (NARCAN) training course. Learn to recognize the signs of an opioid overdose and administer the opioid overdose reversal drug Naloxone.

7.

withpower.com

withpower.com/trial/phase-6-2021-ec5be

Naloxone Communication Training for Pharmacists (Nalox- ...

While its safety in non-medical settings hasn't been formally established, it is expected to be similar to medically supervised experiences. Serious adverse ...

8.

cdc.gov

cdc.gov/overdose-prevention/hcp/toolkits/naloxone.html

Naloxone Toolkit | Overdose Prevention

Full module: Talking about Naloxone. This module includes an optional risk factors assessment for opioid-related harms and provides ...

9.

health.maryland.gov

health.maryland.gov/pha/NALOXONE/Pages/Core-Curriculum.aspx

Core Naloxone Training Curriculum

Core Naloxone Training Curriculum. COMAR 10.47.0 8.04 outlines the minimum requirement for training third parties to carry and administer naloxone.