Slow-Release Buprenorphine Safe in Mild OUD Withdrawal

TOPLINE: 

Injectable, extended-release buprenorphine was deemed safe for patients experiencing minimal to mild opioid withdrawal (COWS scores 4-7), making the drug a viable and safe treatment option, according to a study published in JAMA Network.

METHODOLOGY:

The study was conducted in four emergency departments of adult patients with moderate to severe opioid use disorder (OUD) and Clinical Opiate Withdrawal Scale (COWS) scores that were minimal to mild or under 8.The sample size included 100 people, three fourths of whom had COWS scores between 4 and 7, and the remaining with scores less than 4.Patients were given a one-time 24-mg dose of US Food and Drug Administration–approved drug CAM2038, equivalent to 16 mg of buprenorphine, and remained in the hospital facility for four hours after the injection to monitor the severity of withdrawal symptoms.Researchers consulted with patients daily via telephone for 7 days. Site-injection results were available for 93 patients on day 7.The mean age of the participants was 36.5 years (28% women), a little over one third were Black or African American, and half were White.

TAKEAWAY: 

Within 4 hours of injection, 10 patients had COWS scores that increased by 5 points or more, seven experienced withdrawals that were moderate or greater.Ninety-three patients were available for assessment on day 7 of the trial, with about half rating the treatment as “completely effective” and noted its importance in regard to decreasing pharmacy visits (75%) and eliminating the need for daily medication (67%).On day seven, 73 patients included in the study had started treatment for OUD.

IN PRACTICE:

“This finding may have a significant public health impact in light of the continued increase in opioid deaths in 2023 driven primarily from fentanyl and the heightened risk of overdose death without medication treatment. Our findings should provide a valuable, new option for clinicians reticent to offer buprenorphine in patients using fentanyl,” the study authors wrote.

SOURCE:

The study was led by Gail D’Onofrio, MD, of the Department of Emergency Medicine at the Yale School of Medicine in New Haven, Connecticut, and published on July 8, in JAMA Network.

LIMITATIONS:

The study took place in a small number of emergency departments. Eligibility rules were strict and there was no control group. Investigators used their own discretion in the patient selection process, which may have introduced bias. The study provided CAM2038 at no cost.

DISCLOSURES:

Various authors reported receiving grants and fees from the Foundation for Opioid Response Efforts, the Emergency Medicine Foundation, Braeburn Pharmaceuticals, and Berkshire Biomedical, among others. 

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