Amidst the escalating opioid crisis, a new clinical trial is set to launch this year to directly compare the effectiveness of methadone and buprenorphine in treating opioid addiction, particularly in the context of widespread fentanyl use. The study, overseen by David Fiellin at Yale Medical School, will assess patients' ability to remain in treatment when prescribed either buprenorphine or methadone in an office setting, a novel approach in the current fentanyl era.
Many individuals seeking treatment for opioid addiction have found methadone to be the only effective medication for easing cravings and withdrawal symptoms, especially since the proliferation of fentanyl. However, there is limited data comparing methadone to buprenorphine, its main alternative, particularly when prescribed outside specialized opioid treatment programs (OTPs).
Addressing the Unmet Need
The trial aims to address the critical gap in research, as existing studies have primarily focused on patients already in stable recovery. This new study will focus on less stable patients who have not yet entered treatment, representing a more relevant population given the challenges of early addiction treatment.
"While we do have hints from the scientific literature that methadone has better outcomes with respect to retention in treatment and decreases in illicit drug use, we actually don’t have that literature in patients who are primarily using fentanyl," said David Fiellin.
Calls for Expanded Methadone Access
With opioid overdose deaths at an all-time high, there are increasing calls to make methadone more accessible, similar to other medications, through prescriptions from doctors and pharmacies. Currently, methadone treatment is largely restricted to OTPs, requiring daily in-person visits for medication dispensing.
Senators Ed Markey and Rand Paul introduced a bill last year to allow doctors to prescribe methadone directly to patients, who could then pick it up at a pharmacy. The American Medical Association has also indicated support for doctors prescribing methadone in certain circumstances.
International Perspectives
Noa Krawczyk, a professor at the NYU Grossman School of Medicine, noted that countries like Australia, the U.K., and Canada have successfully integrated office-based methadone treatment with specialty programs for many years.
Trial Logistics and Regulatory Considerations
The clinical trial's sponsors anticipate receiving special research exceptions from the Drug Enforcement Administration (DEA) to allow doctors to prescribe and pharmacies to dispense methadone for the study. The trial is expected to take several years to complete, involving site selection, regulatory approvals, patient enrollment, and outcome measurement.
Implications for Patient Care
"We know that a lot of people actually need methadone because they can’t use buprenorphine," Krawczyk said. "Yet methadone is only available through this very restrictive OTP system, so having the option of getting methadone in an office-based setting is going to be really life-changing for a lot of people."
