Clinical Trials
Treatment of Withdrawal from Opiates in Newborn Infants
Heroine addicted pregnant women are often treated with methadone, a synthetic opiate that crosses the placenta and the fetus becomes addicted. Following delivery these babies undergo severe withdrawal (Neonatal Abstinence Syndrome or NAS). The two most common drugs used to treat these babies are methadone and morphine, gradually titrating the dose in the hospital until the baby is asymptomatic. This is a randomized, multi-site clinical trial comparing the efficacy and long term (2 year) effects of these drugs on medical, neurobehavioral (NNNS), genetic and epigenetic measures. Primary Investigator: Barry Lester PhD.
Walking Reduces Stress in Pregnant Women with Depression
Depressive symptoms are prevalent among pregnant women and consistently linked with adverse outcomes for both women and infants. Few interventions have been developed to reduce prenatal depressive symptoms. Because pregnant women are often reluctant to take antidepressants, a pressing need exists to evaluate interventions that are efficacious in reducing symptoms and more acceptable and accessible to pregnant women. The American College of Obstetricians and Gynecologists strongly recommends regular physical activity throughout pregnancy, yet, in practice, many pregnant women are unsure of how to safely adhere to this recommendation. Findings from our research indicate that a tailored, supported physical activity intervention would be acceptable to depressed pregnant women and would be preferable over pharmacotherapy. No study to date, however, has evaluated physical activity as an intervention for depressed pregnant women. Our team recently developed a gentle, 10-week, pedometer-based walking intervention designed for pregnant women, the Prenatal Walking Program (PWP), including detailed intervention manuals, interventionist training programs, and adherence scales. The current study is a RCT to evaluate PWP in comparison with a perinatal-focused Health Education Control (HEC) condition. The primary aim is to examine whether the PWP group has greater reductions in depressive symptoms relative to healthy controls. In addition, infant neurobehavioral exams (NNNS) will evaluate possible benefits from the intervention. Potential mechanisms will also be tested, including behavioral factors (behavioral activation, decreased avoidance), psychological factors (increased self-efficacy), and physiological factors (decreased inflammation, improved sleep). Primary Investigators: Cynthia Battle PhD, Amy Salisbury PhD.