Nalox-Comm: 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

48 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if training pharmacists on how to talk about naloxone can help them dispense it more effectively and improve patient understanding. The study involves 120 pharmacists and measures their performance over time.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Nalox-comm Training Module, Prescribe to Prevent: Overdose Prevention and Naloxone Rescue Kits for Prescribers and Pharmacists?

Research shows that programs providing naloxone (a medication that can reverse opioid overdoses) and training healthcare professionals in its use can reduce overdose deaths. Studies have found that distributing naloxone and educating both healthcare providers and patients about its use are effective strategies in preventing fatalities from opioid overdoses. ^{1 2 3 4 5}

Is naloxone safe for human use?

Naloxone has a long history of safe use in treating opioid overdoses by healthcare professionals. While its safety in non-medical settings hasn't been formally established, it is expected to be similar to medically supervised experiences. Serious adverse reactions are rare, but higher doses can cause withdrawal symptoms in opioid-dependent individuals. ^{6 7 8 9 10}

How is the Nalox-comm Training Module unique compared to other overdose prevention treatments?

The Nalox-comm Training Module is unique because it focuses on educating prescribers and pharmacists about overdose prevention and the use of naloxone rescue kits, which can help save lives during opioid overdoses. This approach emphasizes training healthcare professionals to better support patients at risk, rather than just providing the medication itself. ^{2 4 5 11 12}

Research Team

Delesha Carpenter, PhD, MSPH

Principal Investigator

UNC Eshelman School of Pharmacy

Eligibility Criteria

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

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

Treatment Details

Interventions

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

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

The role of increasing pharmacy and community distributed naloxone in the opioid overdose epidemic in Massachusetts, Rhode Island, and New York City. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Implementing an overdose education and naloxone distribution program in a health system. [2022]

3. Netherlands 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. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Facilitators, barriers and lessons learnt from the first state-wide naloxone distribution conducted in West Virginia. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Implementation and assessment of a naloxone-training program for first-year student pharmacists. [2019]

6. England pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Opioid Overdose Prevention Programs Providing Naloxone to Laypersons - United States, 2014. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

An Opioid Education Program for Baccalaureate Nursing Students. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

A Review of Opioid Overdose Prevention and Naloxone Prescribing: Implications for Translating Community Programming Into Clinical Practice. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Addressing the opioid epidemic through community pharmacy engagement: Study protocol for a randomized controlled trial. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Development and implementation of intranasal naloxone opioid overdose response protocol at a homeless health clinic. [2022]

12. Netherlands 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. [2021]