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Symptom-triggered methadone improves outcomes in neonatal opioid withdrawal syndrome
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Giving methadone to infants with neonatal opioid withdrawal syndrome based on their symptoms rather than in a fixed schedule significantly reduced their length of stay and resulted in fewer days of opioid treatment, according to findings of a single-center quality improvement study.
“Our study showed that treating symptoms acutely with medication, and not having a fixed schedule with a long taper, not only improves patient outcomes but shortens their hospitalizations and decreases further exposure to opioid medications,” study author Elisha Wachman, MD, a neonatologist at Boston Medical Center, said in a press release. “This novel approach prioritizes the nonpharmacologic care approach for infants experiencing withdrawal symptoms and decreases the risk for unintended dependence that frequently occurs when infants are placed on prolonged methadone or morphine tapers.”
Wachman and colleagues conducted the study at their urban academic medical center, which has a specialized prenatal program for women with substance use disorders. More than 90% of the women in the program are on methadone or buprenorphine for opioid use disorders.
From June 2016 to November 2017, the institution administered methadone to 48 infants with neonatal opioid withdrawal syndrome (NOWS) every 8 hours (0.2-0.8 mg/kg per day) — defined as a fixed-schedule methadone taper, or FSMT. Between July 2016 to November 2017, 28 infants were treated using a symptom-triggered methadone approach (STMA).
Infants treated with STMA had a shorter median length of stay (LOS) compared with infants in the FSMT group (10.5 days vs. 17 days; P = .003). Six infants failed a trial of STMA during the study period and were later switched to FSMT. The 22 infants who were successfully treated with STMA had a median LOS of 10 days compared with 17 days in the baseline FSMT group (P < .0001).
The researchers also said there were fewer methadone treatment days in the STMA group (2.5 days vs. 11.7 days; P = .0001).
Wachman and colleagues wrote that STMA “has the potential to become the new treatment paradigm for NOWS,” but larger and more rigorous studies are needed. – by Katherine Bortz
Disclosures: The authors report no relevant financial disclosures.
Perspective
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Walter K. Kraft, MD
The current paradigm of pharmacologic therapy for neonatal abstinence syndrome (NAS)/NOWS splits infants into two groups: those who can be managed with nonpharmacologic approaches alone and those with more severe disease who also require treatment with an opioid. We know babies exposed to opioids in utero manifest withdrawal symptoms along a spectrum of disease severity. The symptom-triggered approach as a concept is appealing because it may be suited to a middle group — those with intermediate severity of symptoms.
The results of the report using commonly accepted endpoints of LOS and treatment with an opioid are impressive. The retrospective nature and lack of randomization limits the external validity of the findings. The groups were unbalanced regarding exposure to benzodiazepines, a strong driver of NAS/NOWS severity. Adjusted analysis attempted to control for this, but other nondrug improvements in nonpharmacologic care are not easily captured (examples may be changes of staff enthusiasm or maternal clinic dynamics) and may have changed over time from fixed dose to symptom dosed. The manuscript also did not provide data about growth parameters, which would speak to another measure of adequacy of withdrawal symptom control.
These caveats aside, the symptom-based approach is novel and imaginative. These initial quality improvement-driven approaches should be followed up with comparative approaches that include randomization and prospective parallel treatment groups, perhaps in a pragmatic clinical trial.
Methadone has highly variable pharmacokinetics between infants. Future directions may include innovative use drug concentrations to identify infants more likely to respond to a symptom-only approach to methadone dosing.
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