This is a non-inferiority, open label, randomized trial of women on buprenorphine Medication Assisted Therapy for opioid use disorder in pregnancy.Patients will be randomized to either the long acting monthly subcutaneous SublocadeTM or to short acting sublingual Suboxone®.
Opioid use disorder increased among pregnant women in recent years, despite an overall decrease in the general population in the same time frame. Given the increased use of buprenorphine for opioid use disorder, it has now become the most commonly misused prescription opioid subtype. Untreated opioid use disorder is associated with worse maternal, fetal, and neonatal outcomes. To improve compliance with medication assisted therapy, decrease relapse and neonatal abstinence syndrome, we propose a randomized control trial of long acting subcutaneous buprenorphine compared to short acting sublingual buprenorphine/naloxone administration in pregnant and lactating women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
To improve compliance with medication assisted therapy, decrease relapse and neonatal abstinence syndrome, we propose a randomized control trial of long acting subcutaneous buprenorphine compared to short acting sublingual buprenorphine/naloxone administration in pregnant and lactating women.
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, United States
Evaluating the compliance with prescribed medication is not inferior in women assigned to SublocadeTM compared with those to Suboxone®.
Compliance will be assessed by urine drug screens during pregnancy and postpartum visits that are positive for buprenorphine, with assessment of the number of drug screens which are negative for illicit drugs out of the total collected during the study period, with a minimum of three drug screens collected.
Time frame: Through study completion, an average of 1.5 years
Evaluating concentration of buprenorphine and metabolites in maternal plasma
o A weekly blood draw will be collected, with evaluation of drug concentrations at approximate trough and peak levels before and after drug administration. The blood draw around the time of delivery will evaluate the association between drug concentration and neonatal opioid withdrawal syndrome outcomes.
Time frame: Enrollment through four weeks postpartum
Evaluating concentration of buprenorphine and metabolites in cord plasma
Cord blood will be collected and used to estimate fetal exposure to buprenorphine
Time frame: Delivery
Evaluating concentration of buprenorphine and metabolites in breast milk
Breast milk will be collected and used to estimate infant exposure to buprenorphine via breast milk
Time frame: 1-6 months postpartum
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