Reassessing Buprenorphine Dosing in the Context of the Fentanyl Epidemic

Reassessing Buprenorphine Dosing in the Context of the Fentanyl Epidemic

A study from Rhode Island indicates that patients suffering from opioid use disorder who are on lower dosages of buprenorphine are 20% more likely to cease treatment. This finding calls for an urgent reevaluation of dosing protocols, especially in light of the ongoing fentanyl crisis.

A study sponsored by the National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health, urges a reconsideration of existing guidelines for opioid addiction treatment amid the fentanyl epidemic.

The research, which took place between 2016 and 2020, focused on Rhode Island patients who were prescribed buprenorphine. It was published on September 18 in the medical journal JAMA Network Open and was a collaboration between experts at Brown University, Providence, Rhode Island; NIDA, and the Rhode Island Department of Health.

Dosage Guidelines and Patient Outcomes

In the study, 59% of patients who were newly beginning buprenorphine therapy for opioid use disorder and were given the Food and Drug Administration’s (FDA) recommended daily dose of 16 milligrams ceased treatment within 180 days. Likewise, 53% of those on a higher daily dose of 24 mg also dropped out within the same period. A multi-variable statistical analysis demonstrated that patients on the 16 mg recommended dose had a significantly higher likelihood of abandoning treatment compared to those on a 24 mg dose.

Medicines like buprenorphine can safely and effectively assist in reducing opioid use and overdose, while aiding in recovery by suppressing cravings and mitigating withdrawal symptoms. Additional research supports the efficacy and safety of buprenorphine dosages exceeding 16 mg, particularly for emergency department and outpatient treatment contexts.

The Imperative for Evolving Treatment Protocols Amidst the Fentanyl Crisis

NIDA Director, Nora Volkow, M.D., emphasized that while existing treatments can be life-saving, they need to adapt to challenges presented by the proliferation of fentanyl. If future research affirms that higher buprenorphine dosages lead to improved retention in treatment programs, then it is critical to revise clinical guidelines to enhance treatment effectiveness and promote recovery.

In 2021, over 70,000 of nearly 107,000 reported overdose fatalities were primarily attributed to fentanyl, a synthetic opioid roughly 50 times more potent than heroin. The omnipresence of fentanyl and the corresponding surge in overdose deaths prompt questions about the adequacy of existing buprenorphine dosing guidelines in addressing this potent opioid’s unique challenges. The FDA’s current labeling states that maintenance doses should range between 4 mg and 24 mg per day, with 16 mg as the daily target dose for the majority of patients. However, recommended treatment dosages can also be highly individualized.

Study Design and Findings

The study analyzed retrospective data from 6,499 Rhode Island residents who initiated buprenorphine treatment for opioid use disorder from 2016 to 2020, corresponding with the period of fentanyl’s emergence and dominance. Most patients were male, aged between 25 and 44, and had either private or Medicaid insurance. The aim was to assess the correlation between daily buprenorphine doses and retention in treatment over a period of 180 days, in alignment with the minimum duration established by the U.S. Centers for Medicare and Medicaid Services for assessing treatment continuity.

According to statistical analysis, patients on a 24 mg daily dose of buprenorphine were more likely to remain in treatment than those on the FDA’s recommended target dose of 16 mg. Those on the latter dosage were 20% more likely to cease treatment.

Dr. Rachel Wightman, M.D., Associate Professor of Emergency Medicine and Epidemiology at Alpert Medical School of Brown University, and one of the study’s primary investigators, emphasized the obligation to set patients up for success, particularly considering that the current recommended buprenorphine dosages were formulated before fentanyl became widely available.

Future Directions in Research

Continuing investigations aim to initiate a prospective randomized clinical trial to evaluate the effectiveness of daily buprenorphine doses up to 24 mg in enhancing treatment retention and minimizing overdose and fatality risks. This upcoming trial will also explore other potential factors affecting retention in treatment, including healthcare providers’ prescribing habits and patients’ socio-demographics and life circumstances. Outcomes of this research may eventually contribute to updates in opioid use disorder treatment standards.

Reference: The research was funded by the National Institute on Drug Abuse, part of the National Institutes of Health, under award number UG3DA056880. The findings are solely the authors’ responsibility and do not necessarily reflect the official views of the National Institutes of Health.

Frequently Asked Questions (FAQs) about Buprenorphine Dosing

More about Buprenorphine Dosing

• JAMA Network Open: “Buprenorphine Dose and Time to Discontinuation Among Patients With Opioid Use Disorder in the Era of Fentanyl”
• National Institute on Drug Abuse (NIDA)
• U.S. Food and Drug Administration (FDA) – Buprenorphine Information
• Centers for Medicare & Medicaid Services