A new study led by researchers at Columbia University indicates that patients who receive methadone take-home doses—a protocol expanded during the COVID pandemic—are no more likely to overdose or drop out of care than those whose methadone is delivered at government‐approved opioid treatment programs.
The findings, published Dec. 4 in Lancet Regional Health Americas, could eventually result in improving access to this proven, life-saving treatment and help close the gap in care.
There are currently 1,800 opioid treatment programs in the United States dispensing methadone to about 400,000 people annually, a fraction of those who report developing opioid use disorder (OUD) in a given year.
“The vast majority of people living with opioid use disorder are not receiving methadone, considered the gold standard of treatment,” said lead study author Arthur Robin Williams, MD, MBE, assistant professor of clinical psychiatry at Columbia and a research scientist at New York State Psychiatric Institute. “Increasing take-home doses is one way to help reduce overdoses and deaths.”
Restrictive regulations
More than 107,000 Americans died of drug overdoses in 2021, a 15% increase from 2020, with deaths led by opioids, such as heroin and fentanyl. Despite the worsening of the opioid epidemic, patients in need of treatment must travel to government-approved opioid treatment programs (OTPs), where staff is required to observe them taking the medication.
In March 2020, to reduce contact at clinics, the Substance Abuse and Mental Health Services Administration (SAMHSA) permitted OTPs, with state approval, to dispense a larger supply of methadone take-homes. Patients deemed stable could take home a 28-day supply, akin to monthly pharmacy prescriptions; other patients received up to a 14-day supply.
To assess the impact of these reforms, the research team, which included investigators from the NYU Grossman School of Medicine, recruited 1,200 patients with OUD entering methadone maintenance programs. The cohort comprised two study groups (n=600 each) based upon their methadone treatment periods: prior and post COVID pandemic.
The investigators tracked electronic health records for patients newly entering treatment in 2020 and compared their clinical outcomes to control groups admitted in 2019.
“We primarily looked at retention in treatment; adverse events, such as overdose; and rates of drug use,” said senior investigator Edward V. Nunes, MD, professor of psychiatry at Columbia and a research scientist at the New York State Psychiatric Institute.
First empirical study
Over a six-month period, the researchers found that adherence to methadone maintenance and adverse events were equivalent across groups despite higher rates of opioid and methamphetamine use in the 2020 cohort following regulatory reforms.
They also discovered that more half of the sites barely increased their take-home schedules despite wide latitude to do so.
“There is currently a seismic debate at the federal level between health and law enforcement agencies about how to reform access to opioid use disorder treatment,” Dr. Williams said. “This is the first empirical study with electronic health records data in the U.S. that also has a control group. We hope that policymakers will take these findings into consideration when determining which reforms to keep in place versus rescind.”
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