UC study examines treatment for opioid use disorder
National clinical trial looks at use of a medicine to help expectant moms with the condition
The number of women with opioid use disorder during labor and delivery has risen over the years, according to the National Institute on Drug Abuse.
However, if a pregnant woman attempts to suddenly stop using drugs and alcohol without medical help, she can put her fetus at risk.
Now, a National Institutes of Health-funded study, led by researchers at the University of Cincinnati, is investigating whether a medication already used to treat these women may be more beneficial in an extended-release form. Extended-release medications are slowly released into the body over a period of time.
This clinical trial is an example of the innovation agenda under President Pinto's Next Lives Here strategic direction.
Theresa Winhusen, PhD, the Donald C. Harrison Endowed Chair in Medicine and vice chair for addiction sciences in the Department of Psychiatry and Behavioral Neurosciences at the University of Cincinnati. She is the director of the Center for Addiction Research and is leading this national clinical trial. Photo credit/Colleen Kelley/UC Creative + Brand
“The growing opioid use epidemic in the U.S. has been associated with a significant increase in the prevalence of pregnant women with opioid use disorder and of infants experiencing opioid withdrawal syndrome after birth, a condition associated with adverse health effects for the infant,” says Theresa Winhusen, PhD, the Donald C. Harrison Endowed Chair in Medicine and vice chair for addiction sciences in the Department of Psychiatry and Behavioral Neurosciences at the University of Cincinnati.
“The American College of Obstetricians and Gynecologists and the American Society of Addiction Medicine recommend that pregnant women with opioid use disorder be treated with medication including buprenorphine, which is used to treat this disorder and can be administered in a number of ways, but in this case is delivered under the tongue,” she said.
Winhusen, who is also director of the UC Center for Addiction Research, says that while this form of medication delivery can be beneficial, there are disadvantages including daily self-administration by the patient and a period of time each day when the dose within the patient’s system may be too low.
“This extended-release formulation will be injected under the skin by a medical provider, and it releases buprenorphine steadily for an extended period of time,” she adds. “By comparing this formulation with the current formulation, this study has the potential to expand available treatment options for pregnant women struggling with opioid use disorder.”
We hope that this study sheds light on a new and effective way to help these women and their babies, creating a better quality of life for them and helping them succeed.
Theresa Winhusen, PhD
The national, multisite trial is the first to study this formulation in pregnant women. In all, 300 participants will be chosen randomly either to receive the extended-release formulation or the current standard of care. About 25 of those will be recruited locally at the UC Health perinatal addictions clinic, led by Christine Wilder, MD, associate professor in the Department of Psychiatry and Behavioral Neurosciences, a UC Health physician and member of the Center for Addiction Research.
“We hope that this study sheds light on a new and effective way to help these women and their babies, creating a better quality of life for them and helping them succeed,” Winhusen adds.
Featured photo of a woman's pregnant stomach courtesy of Unsplash.
How to participate
Participants for the study need to be expectant mothers between the ages of 18 and 41 who struggle with illicit opioid use. Study participants must be willing to engage in prenatal care, treatment for opioid use disorder and be randomized to receive either form of the treatment. If you or someone you know would be interested in this study, please call 513-725-6329.
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