Prescription opioids (PO) are prescribed to an astonishingly high number of pregnant women: 14-21% of women living in the U.S. receive these medications during pregnancy. Our preliminary data further demonstrate that an alarmingly high number of women use and misuse these medications throughout pregnancy. The overall benefit of these medications is questionable when considering the maternal risks associated with PO misuse (e.g., PO abuse, unintentional overdose, death) as well as fetal risks associated with in-utero PO exposure (e.g., fetal malformations, low birth weight, prematurity, neonatal abstinence syndrome). Despite the tragic consequences and costly effects of PO exposure in pregnancy, no evidence- based non-pharmacological interventions are available to reduce pain, PO use and misuse in pregnancy. The candidate will fill this critical gap and address this unmet clinical need by pursing the following training and research activities. The proposed Mentored Patient-Oriented Career Development Award (K23) is specifically designed to provide state-of-the science addictions research training, and hands-on-experience and mentorship in addictions research (Primary Mentor: Kathleen Brady, MD, PhD), addictions in pregnancy (Hendree Jones, PhD) treatment development and evaluation (Sudie Back, PhD), pain management (Jeffery Borckardt, PhD; John Otis, PhD) and obstetrics research (Roger Newman, MD). The candidate's long-term training goal is to achieve independence as a patient-oriented addictions researcher. The candidate's long- term research goal is to develop addictions-focused interventions for pregnant women. The research objectives of the current application are to: 1) Develop a behavioral intervention to reduce pain, PO use and misuse during pregnancy; and 2) Evaluate the feasibility and preliminary effects of the intervention. The central hypotheses are that pregnant women using POs will be willing to take part in Cognitive Behavioral Therapy (CBT) for the reduction of pain, PO use and misuse in pregnancy and, those receiving CBT will have less pain, PO use and misuse. Guided by preliminary data, these hypotheses will be tested by pursuing two-specific aims: 1) Conduct an open label pilot study of CBT for Chronic Pain, in pregnant women using PO medications and obtain key-informant feedback that will guide modifications of the CBT program; and 2) Conduct a pilot randomized controlled trial to evaluate the feasibility and preliminary effects of the modified CBT program, compared to an attention control condition, Women's Health Education (WHE), in reducing pain, functional impairment and PO use and misuse during pregnancy. The proposed research will result in a critical advance in knowledge about the management of PO use during pregnancy. The contribution of this research is significant because it has the potential to improve the lives f women and their children by: 1) improving maternal pain and functioning; 2) decreasing opioid exposure in pregnancy and associated adverse outcomes; and 3) preventing long-term risks associated with PO use including opioid misuse, abuse, overdose and death.
Prescription opioid use during pregnancy has increased by 5-fold over the past decade and has become a major public health problem due to its impact on maternal and fetal health and overutilization of healthcare resources. Evidence-based non-pharmacological interventions are greatly needed to address this important public health problem. Directly in line with the research priorities set forth by the National Institute on Drug Abuse, this proposal will provide the necessary training and mentorship to facilitate the transition of the candidate into a federally- funded researcher leading addictions-focused treatment studies that will address the public health burden of prescription opioid use in pregnancy and ultimately improve the lives of women, their children and families.
