CDC and New York State Department of Health Publish Study On Effectiveness of 4 Milligram Versus 8 Milligram Naloxone During Opioid Overdose

Study Supports Continued Use of 4 Milligram Naloxone Products

Key Findings Show Lower Dose Naloxone Equally Effective at Aiding Opioid Overdoses, While Higher Naloxone Dose is More than Twice as Likely to Lead to Increased Post-Naloxone Withdrawal Signs and Symptoms

99 Percent of Individuals Who Received Naloxone During the Field Test Survived

ALBANY, N.Y. (February 8, 2024) –The New York State Department of Health, in partnership with the New York State Police, has published a groundbreaking field test study on the effectiveness of 4 milligram/0.1 cubic centimeters versus 8 milligram/0.1 cubic centimeters naloxone administration during an opioid overdose in the Centers for Disease Control and Prevention's CDC Morbidity and Mortality Weekly Report (MMWR).

In the field test study titled, "Comparison of Administration of 8 Milligram and 4 Milligram Intranasal Naloxone by Law Enforcement During Response to Suspected Opioid Overdose – New York, March 2022-August 2023," key findings support State Department of Health recommendations that the 4 mg dose is not only equally effective at aiding opioid overdose, but also resulted in fewer common post-naloxone symptoms (withdrawal symptoms) than the 8 mg dose.

"Opioid overdose is a serious public health concern, especially with the prevalence of potent synthetic opioids like fentanyl," State Health Commissioner Dr. James McDonald said. "This study is about saving lives and is vital to our harm reduction efforts across New York State as we work in pharmacies, in our communities, and with first responders to help everyday New Yorkers who have been impacted by the opioid overdose crisis."

New York State law enforcement are equipped with 4 mg naloxone and often administer two doses, leading to the idea that higher initial doses might be needed. In 2021, an 8 mg intranasal naloxone product was approved by the FDA, producing an opportunity for this first-of-its kind study comparing the products. From March 2022 to August 2023, the State Department of Health supplied some New York State Police troops with 8 mg intranasal naloxone, while other troops continued to receive the 4 mg product to treat suspected overdoses.

During this time, the study observed real-time naloxone administration by NYSP and found that increased concentration (8 mg) did not provide added benefit in reversing an opioid overdose. In fact, researchers involved in the study found opioid withdrawal symptoms, including vomiting, were significantly more prevalent – more than twice as likely – among 8 mg naloxone recipients (37.6 percent) than 4 mg recipients (19.4 percent). Other common post-naloxone signs and symptoms experienced among both groups were disorientation (8 mg recipients: 66.3 percent; 4 mg recipients: 58.5 percent) and lethargy (8 mg recipients: 52.5 percent; 4 mg recipients: 43.5 percent).

This initial study suggests no benefits to law enforcement administration of higher-dose naloxone were identified. Overall, 99 percent of individuals who received either dose of naloxone during the field test survived, further underscoring the Department's efforts to make naloxone available and accessible without a prescription.

"These programs save lives," Sharon Stancliff, MD, study corresponding author and Associate Medical Director of Harm Reduction in Health Care at the NYSDOH AIDS Institute said. "As in all of medicine, we want to avoid causing unnecessary suffering for our patients without adding benefits, whether they be struggling with opioid use disorder or prescribed opioids for pain management."

"The New York State Police is honored to have partnered with the New York State Department of Health on this vital research project," New York State Police Acting Superintendent Steven G. James said. "One of the missions of the New York State Police is to render assistance to victims. We are committed to providing our community with the highest quality of support, and this effort is critical to saving the lives of victims in the event of an overdose."

"The partnership between the Department of Health and the New York State Police has been a key component of New York State's opioid overdose response since 2014," Michael Dailey, MD, Professor of Emergency Medicine, Albany Medical College said. "It is important for the public to know that rapid recognition and activation of 911 are a key part of surviving opioid overdose; the police are coming to help. It is remarkable that in this study, 99% of the people that could have been saved and received either formulation of naloxone from the Troopers survived."

"I commend our partners at the state level for their work on this important study," New York City Department of Health and Mental Hygiene Executive Deputy Commissioner of Mental Hygiene Deepa Avula said. "We look forward to continuing our efforts to make this lifesaving medication available across New York City as we work together to prevent overdose deaths."

Opioid overdose remains a significant public health crisis and putting naloxone into the hands of communities and in proximity to people who use drugs, their family members, friends, and colleagues remains a cornerstone response to reducing overdose deaths.

The Department supports more than 1,000 registered Opioid Overdose Prevention Programs (OOPP) in New York State. This program reaches the most vulnerable members of the community via syringe exchange programs, health care facilities, drug treatment programs, local health departments, and libraries. Moreso, law enforcement, firefighters, and many more make naloxone available to the public as a lifesaving tool to reverse opioid overdose and prevent death.

Currently, naloxone is available at pharmacies either through the Department's standing order or with a prescription. In most cases, New York State covers the co-payment. OOPPs can provide access to other care and can either provide materials, such as fentanyl test strips, or direct people as to where they can be obtained.

More information on the state's Opioid Overdose Prevention Program can be found here.

Overdose awareness information, including addiction and substance use disorder educational resources, can be found here.