Pharmacotherapy Research for the Treatment of In Utero Substance Exposed Neonates: Advances and Future Directions

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Meeting Summary

NIDA Organizer: Steve Oversby, Psy.D., R.N. under Medication Research Grants Branch, Division of Pharmacotherapies and Medical Consequences of Drug Abuse

Meeting Purpose and Intent:

The consequences of substance abuse on the unborn child is a major public health concern. In the Sixth Triennial Report to Congress, NIDA estimated that 5.5 percent of women use some illicit drug during pregnancy, translating into approximately 221,000 babies who have the potential to be born drug exposed. Substance abuse during pregnancy often occurs in the context of complex environmental, poly-drug exposure and medical factors which are associated with adverse neonatal consequences including premature delivery, low birth weights and smaller head circumferences, and shorter body lengths, than infants not exposed in utero to drugs. Clinical research has focused on effective pharmacotherapy and non-pharmacotherapy treatments for the effects of alcohol and drugs on the unborn child. The advances in knowledge, especially in the areas of identification, assessment and treatment of Neonatal Abstinence Syndrome and Fetal Alcohol Spectrum Disorders, have laid the foundation for the next generation of research in the area of In Utero Substance Exposed Neonates. The purpose of this NIDA workshop is to develop ideas, concepts, and research questions addressing new pharmacotherapy research for the treatment of in utero substance exposed neonates. To this end, the workshop will review the current research on this topic through presentations by leading researchers in the field on the areas of a) In utero opiate exposure including the Neonatal Abstinence Syndrome, b) In utero stimulant exposed neonates, and c) In utero exposure to other drugs of abuse (including alcohol and tobacco exposure). Discussion sessions followed with the workshop goal of developing a future direction for clinical research in the area of treatment of in utero substance exposed neonates through collaboration.

Meeting Outcome:

Seventeen (17) of the preeminent experts in the field of In-Utero Substance Exposure convened to discuss current research and future directions, for this two-day workshop. The meeting was divided into several segments. In each segment there were research presentations by several speakers followed by discussion led by the session chair, then general discussion and recommendations for future research. After the final session there was a workshop "wrap up".

Day 1 Session 1, Overview:

The first session included an introduction by Frank Vocci, Ph.D., Director DPMC, NIDA, and four presentations laying out the scope of the public health concern. Ivan Montoya, M.D., M.P.H. (NIDA), gave an in depth presentation on The Public Health Scope of In Utero Substance Exposure. Vince Smeriglio, Ph.D.(NIDA), discussed NIDA's Longitudinal Cohort Studies of Prenatal Drug Exposure. Jamie Biswas, Ph.D. gave an overview on the types of projects funded by DPMC. Loretta Finnegan, M.D., (Finnegan Consulting Inc.) as the keynote speaker, provided an overview of this area of research.

Day 1 Session 2; Pharmacotherapy of In-Utero Opioid Exposed Infants, Advances and Future Directions:

The second session, chaired by Karol Kaltenbach, Ph.D. (Thomas Jefferson U.), involved seven presentations on pharmacotherapy for In Utero Opioid Exposed Infants followed by a discussion period on the advances and future directions of this research area. Lauren Jansson, M.D. (Johns Hopkins U.) discussed Maternal and Fetal Neurophysiology and Opioid Exposure. . Karol Kaltenbach, Ph.D. reviewed the topic of Opioid Agonists for the Treatment of NAS. Gabriele Fischer, M.D. ( Medical University of Vienna, Austria), discussed Morphine/Barbiturate Treatment in Neonates. Mara Coyle, M.D. (Brown Medical School) discussed the use of DTO and Phenobarbital for the Treatment of Neonatal Opiate Withdrawal in the Term Infant. Estelle Gauda, M.D. (Johns Hopkins U.), presented a talk entitled "Clonidine: An Adjunct Therapy for the Treatment of NAS". Michelle Ehrlich, M.D., and Walter Kraft, M.D. (Thomas Jefferson U.), reviewed an ongoing trial of sublingual buprenorphine for the treatment of NAS. Hendree Jones, Ph.D. (Johns Hopkins U.) discussed the Multi-Site "M.O.T.H.E.R." study and the treatment of NAS.

Day 1 Session 3: In Utero Exposure to Alcohol

The second session, chaired by Laurie Foudin, Ph.D. (NIAAA) included two presentations on In Utero Exposure to Alcohol and a discussion period. Michael E. Charness, M.D. (Chief of Staff VA, Boston Health Care System, and Harvard U.) gave an overview of Fetal Alcohol Spectrum Disorders. Cathy Spong, M.D. (NICHD, NIH) discussed Prevention of Alcohol-Induced Damage in FAS. Laurie Foudin, Ph.D. lead a discussion on the future directions of research in this area.

Day 2 Session 1, Primary Care and In-Utero Drug Exposure:

In this session, chaired by Cora Lee Wetherington, Ph.D. (NIDA), three presentations were given and afterwards Dr. Wetherington lead a discussion period. Firstly Martha Velez, M.D. (Johns Hopkins U.) presented on the topic of Non-pharmacological care of In-Utero Exposed Neonates. The second talk by Martha Wunsch, M.D. (VA College of Osteopathic Medicine) focused on Women with Chronic Pain: the New Face of Addiction. Finally, Peter Selby, MMMBS, CCFP, MHSc (St. Joseph's Health Center, Toronto, Canada), presented on Diagnosis and Treatment of Prenatal Benzodiazepine Exposure.

Day 2 , Session 2, In-Utero Stimulant Exposed Neonates:

In this session, chaired by Hendree Jones, Ph.D., three presentations were given on the topic of In-Utero Stimulant Exposed Neonates, Progress and Future Directions and then a discussion followed. Marylou Behnke, M.D. (U. of Florida) presented on Diffusion Tensor Imaging of Frontal White Matter and Executive Functioning in Cocaine-Exposed Children. Lynne T. Smith, M.D. (UCLA) followed with a presentation on Neurodevelopmental Findings in Children Exposed to Methamphetamine. Lastly Cheryl Oncken, M.D. (U. of Connecticut) presented results of research on the Role of Pharmacotherapies to Reduce Prenatal Tobacco Exposure.

Expected Follow Up:

  • NIDA Web Site Summary and participant list
  • CPDD Follow up at the Perinatal Research Workgroup Meeting
  • Create a Secure Google Group as a forum for the presenters to collaborateProgram collaborations among NIAAA, NIDA, NICHD and SAMHSA