Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Reducing Tobacco use among Opioid Addicted Women

Each year, 225,000 infants in the United States are exposed prenatally to illicit drugs. Women with substance use disorders, particularly those with opioid dependence, are highly vulnerable to cigarette smoking during the perinatal period. Pregnant opioid dependent patients seeking medication-assisted treatment (MAT) have high rates of smoking, ranging from 88% to 95%. Smoking during pregnancy is an independent risk factor (outside of illicit drug use) for several adverse outcomes including ectopic pregnancy, premature birth, orofacial clefts,3 and sudden infant death syndrome. Illicit opioid use magnifies these risks; there is a 6-fold greater risk for intrauterine growth restriction, third trimester vaginal bleeding, preterm delivery, and a majority also will experience neonatal abstinence syndrome (NAS). Prenatal tobacco use significantly increases the severity and duration of NAS, yet is not commonly treated among opioid dependent pregnant women receiving MAT.4 On average, the healthcare cost per discharged infant with NAS ranges from $39,400 to $53,400; and 77.6% is paid for by Medicaid.5 MAT has been shown to decrease the severity of NAS 4,6 compared to no treatment; yet, most opioid dependent women in MAT still continue to smoke cigarettes throughout pregnancy, clearly suggesting that there is a significant need for a comprehensive, evidence-based tobacco treatment intervention. To date, there is no specific pharmacologic or non-pharmacologic tobacco-treatment standard for opioid dependent pregnant women in MAT. More research is needed to develop and test tailored tobacco treatment interventions for pregnant, opioid dependent women. The purpose of this trial is to test a novel intervention for tobacco cessation, Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC), in an established community MAT clinic. B-EPIC is designed to reduce tobacco-associated morbidity (e.g., preterm birth, NAS) and healthcare expenditures in pregnant women who are tobacco users receiving buprenorphine for opioid dependence. This two-group randomized and controlled clinical trial (n =100) will provide critical preliminary data to test larger-scale trials. As nearly all B-EPIC services are billable services via public and private insurers; there is high likelihood for sustainability in community clinics. Aim 1. To determine the impact of the B-EPIC intervention on maternal tobacco use during and after pregnancy compared to the tobacco treatment as usual (TAU) control group among women withopioid dependence receiving MAT. Hypothesis1: The B-EPIC group will have a greater percentage of women who quit smoking (determined by urine cotinine) and/or decrease the number of cigarettes smoked per day during pregnancy than TAU. Aim 2. To determine the impact of B-EPIC on tobacco-related adverse health outcomes including: gestational age at birth, birthweight; NAS diagnosis and severity; and number of infant ear and respiratory infections during the first 5-6 months. Hypothesis2: Women in the B-EPIC intervention will have longer gestational periods and their infants will experience less severe NAS (e.g., # days in the neonatal intensive care unit [NICU], total mg of morphine needed to treat NAS) and associated childhood illnesses (e.g., frequency of ear and respiratory infections) compared to TAU. Aim 3. To compare health care utilization and costs incurred by patients that receive the BEPIC intervention versus TAU, including length in days of maternal hospitalization, # days in NICU, and # of sick infant outpatient or emergency department (ED) visits with estimates of the incremental cost-effectiveness of the B-EPIC intervention. Hypothesis3: Participants in B-EPIC will have lower NICU use, shorter lengths of stay and fewer readmissions, and ED/ill-child outpatient visits than the TAU group, resulting in a beneficial cost-effectiveness ratio.