Toward the Use of Buprenorphine in Infants: Scientific and Practical Considerations: Virtual Workshop

Executive Meeting Summary pdf  1.54 MB

Workshop Description

Buprenorphine is a potential treatment for newborns with neonatal opioid withdrawal syndrome (NOWS). This workshop brings together experts in maternal-fetal medicine, maternal treatment of opioid use disorder, and neonatal outcomes. The attendees will discuss both scientific and practical opportunities and issues conducting trials regarding the use of buprenorphine in newborns with NOWS and other pediatric conditions requiring opioid therapy. This meeting is part of the Helping to End Addiction Long-term Initiative^SM, or NIH HEAL Initiative^SM, research efforts to enhance outcomes for infants and children exposed to opioids.

Objectives

• Review the state of the science, knowledge gaps, and practical considerations regarding use of buprenorphine in infants for treatment of neonatal opioid withdrawal syndrome (NOWS)
• Propose next steps to test the safety and efficacy of buprenorphine for treating NOWS

Agenda: August 24, 2020

10:30 AM - Welcome and Outline of the Day
Dr. Andrew Bremer, MD, PhD, NICHD

10:35 AM - Introductory Remarks
Dr. Diana Bianchi, MD, NICHD
Dr. Nora Volkow, MD, NIDA

SESSION 1: State of the Science and Practice - What Has Been Done So Far?

11:00 AM - What Does Practice Currently Look Like?
Dr. Leslie Young, MD, University of Vermont
Dr. Lori Devlin, DO, MHA, University of Louisville

11:30 AM - History of the Use of Buprenorphine in NOWS
Presenter
TBD

11:50 AM - State of the Science of Buprenorphine in NOWS
Dr. Walter Kraft, MD, Thomas Jefferson University

12:10 PM - State of the Science of Methadone and Morphine for NOWS
Dr. Elisha Wachman, MD, Boston University

12:30 PM – Lunch and CONTINUED DISCUSSION

1:00 PM - SESSION 1: State of the Science Discussion
Speaker panel and audience discussion
Drs. Leslie Young, Lori Devlin, Walter Kraft, and Elisha Wachman
Moderated by Dr. Andrew Bremer, MD, PhD, NICHD

Session 2: Ongoing/Upcoming Trials - Where Are We Going?

1:20 PM - ACT NOW Trials
Weaning, Dr. Adam Czynski, DO, Brown University
Eat/Sleep/Console, Dr. Leslie Young, MD, University of Vermont
OBOE, Dr. Stephanie Merhar, MD, MS, Cincinnati Children's Medical Center

1:40 PM - MOMs Study - Trial Structure and Associated CTN Trials
Dr. Theresa Winhusen, PhD, University of Cincinnati

2:00 PM - Networks Available for Participation
Dr. Betty Tai, PhD, Director CCTN

2:20 PM - SESSION 2: Ongoing Trials Discussion
Speaker panel and audience discussion
Drs. Adam Czynski, Leslie Young, Stephanie Merhar, Theresa Winhusen, Betty Tai
Moderated by Dr. Robert Lindblad, MD, Emmes

Session 3: Feasibility - Operational Lessons From Known Studies

2:40 PM - Identifying the Research Questions
Dr. Andrew Bremer, MD, PhD, NICHD

3:00 PM - SUMMARY OF DAY

Agenda: August 25, 2020

10:30 AM - Outline of the Day
Dr. Andrew Bremer, MD, PhD, NICHD

Session 3: Feasibility - Operational Lessons From Known Studies

10:40 AM - Gaps in Knowledge - Known Operational Challenges
Dr. Jonathan Davis, MD, Tufts University

11:00 AM - Do the Outcomes for the Baby Differ with the Medication to Treat Opioid Disorder in the Mother?
Dr. Hendrée Jones, PhD, University of North Carolina

11:20 AM - Feasibility for Buprenorphine in Neonates
Dr. Stephanie Merhar, University of Cincinnati
Dr. Brenda Poindexter, MD, MS, Emory University

11:40 - Regulatory Considerations
Dr. Gioia Guerrieri, MD, FDA

12:00 PM - Where do we need to go?
Dr. Alan Simon, MD, NIH ECHO

12:20 PM - SESSION 3: Feasibility
Panel and audience discussion
Drs. Jonathan Davis, Hendrée Jones, Stephanie Merhar, Brenda Poindexter, Gioia Guerrieri, and Alan Simon
Moderated by Dr. Andrew Bremer, MD, PhD, NICHD

12:40 PM - Lunch and CONTINUED Discussion

Session 4: Next Step - How Do We Get There

1:10 PM - What Are Clinically Meaningful Neurodevelopmental Outcomes to Measure in Infancy?
Dr. Lauren S. Wakschlag, PhD, Northwestern University

1:30 PM - Non-Neurodevelopmental Outcomes in the Care of NOWS Infants
Dr. Amy Salisbury, PhD, Virginia Commonwealth University

1:50 PM - Treatment Groups and Subgroups - What Should We Be Testing?
Dr. Jonathan Davis, MD, Tufts University

2:10 PM - Statistical Considerations
Dr. Abby Matthews, PhD, Emmes

2:30 - SESSION 4: Next Steps Discussion
Speaker panel and audience discussion
Drs. Lauren S. Wakschlag, Amy Salisbury, Jonathan Davis, Abby Matthews 
Moderated by Dr. Andrew Bremer, MD, PhD, NICHD

2:50 PM - MEETING SUMMARY
Dr. Andrew Bremer, MD, PhD, NICHD

3:00 PM - Comments from Attendees

3:45 PM - ADJOURN