Following random assignment to methadone or buprenorphine, maternal participants received study medication in a double-blind, double-dummy manner to protect the study blind, and also received voucher-based incentives contingent upon negative urinalysis results to minimize other drug use.
#Disturbed vs undisturbed tremors trial#
The MOTHER study was a multi-site randomized clinical trial (RCT) designed to compare the NAS outcomes of neonates exposed in utero to methadone versus buprenorphine. More recently, the Maternal OpioidTreatment: Human Experimental Research (MOTHER) study was completed. small sample sizes, open label, non-randomized designs, high rates of concomitant other drug use that could confound NAS results) tempered the strength of the conclusions that could be drawn from these studies. Many reported results suggestive of a milder, more limited NAS among neonates prenatally exposed to buprenorphine, but methodological limitations (e.g. The promising observations of a milder withdrawal with buprenorphine in adults prompted a number of studies comparing the NAS of infants exposed in utero to methadone versus buprenorphine.
#Disturbed vs undisturbed tremors full#
For example, it has been suggested that autonomic signs of withdrawal in non-pregnant adults are less pronounced after discontinuation of buprenorphine, and that buprenorphine withdrawal may be delayed in onset relative to withdrawal from a full opioid agonist. In addition to demonstrating its efficacy as a maintenance medication, studies testing the clinical utility of buprenorphine in non-pregnant adults also reported that abrupt discontinuation of this medication resulted in a milder withdrawal syndrome that had a different profile compared to withdrawal from full opioid agonists. īuprenorphine, a partial mu agonist and kappa antagonist, was approved for the treatment for opioid dependence in non-pregnant adults in 2002 in the United States. In many instances, methadone-associated NAS requires extended medical monitoring in the early postnatal period and often necessitates pharmacological treatment with opioid agonist medications and prolonged hospitalization. Untreated NAS can result in significant morbidity and mortality. ANS disturbances include sweating, fever, yawning and sneezing. Respiratory distress is indicated by nasal stuffiness and tachypnea. Signs of GI dysfunction include poor feeding, vomiting and loose stools. High-pitched crying, hyperactive Moro reflex, increased muscle tone, sleep disturbances, tremors, excoriation due to excessive movement, excessive irritability and seizures are signs of CNS hyperirritability. NAS is characterized by central nervous system (CNS) hyperirritability, gastrointestinal (GI) dysfunction, respiratory distress and autonomic nervous system (ANS) signs. However, in utero methadone exposure can result in neonatal abstinence syndrome (NAS). In the context of comprehensive care, maintenance treatment with methadone, a full mu agonist, improves maternal and neonatal outcomes relative to no treatment or medication-assisted withdrawal.
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Opioid dependence during pregnancy is often compounded by multiple risk factors contributing to adverse maternal and neonatal consequences.