A faster approach to starting extended-release injectable naltrexone proves effective

For people with opioid use disorder, it is standard practice to begin extended-release naltrexone injection (XR-naltrexone) within 5 to 7 days of receiving treatment, starting within 10 to 15 days. more effective than conventional therapy, but requires close medical supervision.according to the results of a clinical trial led by researchers at the New York State Psychiatric Institute and Columbia University Irving Medical Center.

the study, Published on May 8th JAMA network open Supported by the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH)., This rapid treatment step suggests that XR-naltrexne may become a more viable treatment option for opioid use disorder, which continues to claim lives at an alarming rate.

“Historically, time has been a barrier to the use of extended-release naltrexone for opioid use disorder among both individuals and treatment providers,” said Matisyahu Shulman, MD, lead study author and clinical researcher. Stated. New York State Psychiatric Institute and Columbia University Irving Medical Center. “We hope these findings will help further the practice of offering extended-release naltrexone to patients as a safe and effective option to prevent overdose and support recovery.”

More than 107,000 people will die from drug overdose in 2022, and 75% of those deaths will be due to opioids. The overall increase in overdose deaths is largely due to a surge in the drug supply of illicit fentanyl, a highly potent synthetic opioid. Decades of research have shown the overwhelming benefits of three existing drugs for opioid use disorder: methadone, buprenorphine, and XR naltrexone.

Addressing barriers to XR-naltrexone

XR-Naltrexone One of three Food and Drug Administration-approved Drugs to treat opioid use disorder. It works by binding to and blocking opioid receptors in the brain, reducing cravings for opioids and preventing the euphoric and sedative effects of opioids.

However, to begin treatment with XR-naltrexone, patients have traditionally required a seven to 10-day opioid-free period to avoid painful withdrawal symptoms. It is caused by naltrexone suddenly stopping the effects of opioids in the brain. During this waiting period, patients are at increased risk of returning to opioid use or discontinuing treatment. This is a major barrier to the introduction of XR-naltrexone.

To address this challenge, researchers tested the effectiveness of a faster procedure for starting people on XR-naltrexone. The study enrolled and followed 415 opioid use disorder patients admitted to six community-based addiction inpatient facilities across the United States from March 2021 to September 2022 who chose treatment with XR-naltrexone. . Every 14 weeks, sites were randomized to offer either the standard her-XR-naltrexone procedure or the more rapid procedure.

In this study, a standard XR-naltrexone regimen included a 3-5 day treatment period with buprenorphine to alleviate withdrawal symptoms, followed by a 7-10 day opioid-free period. . This rapid procedure consisted of 1 day of buprenorphine (up to 10 mg), a 24-hour opioid-free period, and his titration of low-dose oral naltrexone for 3 to 4 days before injection of XR-naltrexone. . Doctors also used drugs such as clonidine and clonazepam throughout the process to manage withdrawal symptoms.

Rapid protocols require extreme caution

In this study, patients who received a 5- to 7-day rapid treatment procedure were significantly more likely to receive their first injection of XR-naltrexone compared to patients who received a standard 7- to 15-day treatment procedure. (62.7% vs. 35.8%). The severity of withdrawal symptoms was generally low and comparable between the two groups. Although the safety events and serious adverse events of interest (such as falls and overdose) were less frequent overall, they were more common with prompt treatment (5.3% and 6.7%) than with standard treatment (2.1% and 1.6%). This occurred more often, and more staff were needed to quickly treat it. Note. This indicates that close monitoring and more advanced clinical expertise may be required if patients start treatment with prompt treatment.

Although the shorter wait times have improved the proportion of people starting XR-naltrexone overall, these findings suggest that patients should not start XR-naltrexone or remain on treatment long-term. It emphasizes that there are still challenges to overcome. In both standard and expedited procedures, the most commonly reported reason for a participant not receiving her first dose of XR-naltrexone was because she chose to leave the treatment unit early.

The authors also noted that of all patients who started treatment, only about 10% chose XR-naltrexone. These findings demonstrate that a small but significant proportion of people with opioid use disorder choose treatment with XR-naltrexone when offered all three drug treatments, and that, based on this scientific evidence, We reaffirm the importance of supporting research that makes treatment options more viable for patients. those who choose it.

THis research paves the way for more timely care with one of the three treatments for opioid use disorder available to us, and the ability of people to choose the treatment option that is most effective for them. “We're going to better support them,” Dr. Schulman said.

The authors note that future studies should investigate the sustainability, feasibility, and health economic aspects of this more rapid treatment protocol of XR-naltrexone. Although rapid procedures save days and reduce costs, the resources required for intensive monitoring must also be considered.

of studyis known as Overcoming Withdrawal Symptoms and Initiating Rapid Treatment with Naltrexone (SWIFT) StudyIt was carried out at six sites within. NIDA Clinical Trials NetworkFunded through the NIH Long-Term Initiatives to Help End Addiction (or NIH HEAL Initiative)).

Co-authors of the study include Miranda G. Greiner, MD, MPH; Hiwot M. Tafes, Mississippi. Onumara Opara, MPH; Caitlin Ortman, MA; Kenzie Potter, Bachelor of Science; Dr. Kathryn Hefner. Eve Gelstrom, MBA, CRNA. Richard N. Rosenthal, MD. Dr. Kevin Wenzel; Mark Fishman, MD; John Rotrosen, MD. Dr. Woody E. Gitza; Dr. Edward V. Nunes; and Dr. Adam Bisaga.