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Incidence of Precipitated Withdrawal During a Multisite Emergency Department–Initiated Buprenorphine Clinical Trial in the Era of Fentanyl.PDF

Summary/Abstract

Multi-site clinical trial, less than 1% of people with opioid use disorder (OUD) whose drug use included the synthetic opioid fentanyl experienced withdrawal when starting buprenorphine in an emergency department.

Content

In a recent multi-site clinical trial, less than 1% of people with opioid use disorder (OUD) whose drug use included the synthetic opioid fentanyl experienced withdrawal when starting buprenorphine in an emergency department.

Findings from the study, which was backed by the National Institutes of Health and published on Thursday in JAMA Network Open, indicate that OUD treatment with buprenorphine can be safely started in an emergency department without triggering withdrawal, even among individuals who use stronger opioids.

“We are in an overdose crisis, and we need to deploy every tool we have to help address it,” said Nora D. Volkow, MD, director of the National Institute on Drug Abuse (NIDA), said in a news release. “The emergency department is a crucial care setting for people with substance use disorders. This study provides further evidence that all emergency department physicians can and should be using buprenorphine to help individuals take the first steps into treatment and toward recovery.”

Patients experiencing precipitated withdrawal—the term for withdrawal induced by medications to treat OUD—can be plagued by a rapid onset of aches, nausea and vomiting, diarrhea, and abdominal cramps within 2 hours of taking their first dose of buprenorphine. This has been a source of concern among clinicians because of its potential to dissuade individuals from entering medication-assisted treatment (MAT).

Moreover, weary that patients who have used fentanyl could be at a heightened risk for precipitated withdrawal, some clinicians have prescribed buprenorphine at lower doses. This, in turn, has increased the risk of such patients resuming their use of illicit opioids, as lower buprenorphine doses can be less effective in relieving symptoms.

The study released this week by NIDA, however, could help to allay those concerns.

The clinical trial involved about 1200 adult patients with untreated moderate-to-severe OUD, opioid-positive and methadone-negative urine screenings, and a Clinical Opiate Withdrawal Scale score greater than or equal to 4. For the purposes of the study, precipitated withdrawal was defined as when a patient demonstrated an escalation of at least 5 points on the Clinical Opiate Withdrawal Scale within 2 hours of buprenorphine treatment initiation. Despite a high prevalence of fentanyl use among study participants (76%) precipitated withdrawal was observed in just 9 participants (about 0.76% of the study population), including 0.98% of those who had tested positive for fentanyl.

“Clinicians should encourage patients with opioid use disorder to take buprenorphine if they need it,” study lead author Gail D’Onofrio, MD, professor of emergency medicine, Yale University, New Haven, Connecticut, said in the release. “We know that less than 23% of people with opioid use disorder are getting treated for it, and we only have a few medications for opioid use disorder that have been found to be very effective for opioid withdrawal to date. If we take away one of these, we’re going to have an even bigger gap between need and treatment.

“We hope that both clinicians and patients understand that buprenorphine is a safe and effective option.”