Clonidine monotherapy as effective as morphine in neonatal opioid withdrawal treatment, study finds

Pediatric researchers at the University of Kentucky found that clonidine, an antihypertensive drug typically used to treat high blood pressure, can be as effective as morphine in treating neonatal opioid withdrawal syndromes (NOWS).

Clonidine has previously been used along with morphine to reduce NOWS symptoms. The Kentucky research team investigated the potential of clonidine alone as an alternative to opioid-based treatments, which are commonly used to NOWS but have risk concerns regarding prolonged opioid exposure in neonates.

In a study, “Clonidine as Monotherapy for Neonatal Opioid Withdrawal Syndrome: A Randomized Trial,” published in Pediatrics, 120 infants exposed to opioids in utero were randomly assigned to receive either clonidine or morphine, with doses adjusted based on the severity of withdrawal symptoms.

Both groups had a median treatment duration of approximately two weeks, with 17 days for clonidine and 15 days for morphine, showing no significant difference in treatment time.

A higher proportion of infants in the clonidine group (45%) required adjunct therapy, compared to only 10% in the morphine group. Adjunct therapy consisted of additional medication given to infants who did not adequately respond to the primary treatment of either clonidine or morphine for managing NOWS.

If the initial drug did not control an infant’s withdrawal symptoms, the dose was increased incrementally. If no improvement was seen after several dose increases, a secondary medication, typically phenobarbital, was introduced to help manage the withdrawal symptoms alongside the primary treatment.

Statistical analysis showed that clonidine-treated infants were significantly more likely to need additional medication. The researchers attribute this to clonidine having a delayed onset time, leading to dose escalations and a greater need for adjunct treatment under the trial conditions.

Initially, infants treated with clonidine exhibited worse performance in specific areas, including arousal and signs of stress.

Neurobehavioral outcomes revealed no significant differences between the groups by the end of treatment, indicating that clonidine’s delayed onset time did not lead to long-term differences in outcomes. Both clonidine and morphine were well tolerated, with no significant adverse effects reported during the trial.

While clonidine appears to be a viable non-opioid treatment for NOWS, the study authors suggest further research to optimize dosing strategies. Increasing the initial clonidine dose or adjusting the treatment schedule could reduce the need for adjunct therapies and shorten the time to symptom control.

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