Long Acting Subcutaneous vs Short Acting Sublingual Buprenorphine in Pregnant and Lactating Women

Exclusion Criteria

• •Known allergy or adverse reaction to buprenorphine
• •Abnormal obstetrical ultrasound suspicious for major congenital abnormality
• •Known or suspected fetal aneuploidy (by either CVS (Chorionic Villus Sampling), amniocentesis or cell-free DNA)
• •Participation in another trial that may influence the primary outcome, without prior approval
• •Participation in this trial in a prior pregnancy
• •Higher order pregnancy
• •Have a physiological dependence on alcohol or sedatives requiring medical detoxification
• •Have a psychiatric condition that, in the judgment of the site medical clinician (MC), would make study participation unsafe or which would make treatment compliance difficult. Examples include:
• •* Suicidal or homicidal ideation requiring immediate attention
• •* Severe, inadequately-treated mental health disorder (e.g., active psychosis, uncontrolled bipolar disorder)
• •Have a medical condition that, in the judgment of the study MC, would make study participation unsafe or which would make treatment compliance difficult. Medical conditions that may compromise participant safety or study conduct include, but are not limited to, allergy/sensitivity to study medications and the following based on clinical labs:
• •* aspartate aminotransferase (AST) / alanine aminotransferase (ALT) greater than 5X upper limit of normal
• •* serum creatinine greater than 1.5X upper limit of normal
• •* total bilirubin greater than 1.5X upper limit of normal
• •Currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or other situation (e.g., unstable living arrangements) that, in the judgement of the site investigator, could prevent participation in the study or in any study activities;
• •Currently receiving methadone or naltrexone for the treatment of OUD;
• •Enrolled in or planning to enroll in treatment beyond the level of 3.1 (clinically managed low-intensity residential services) of the American Society of Addiction Medicine criteria
• •Enrolled in or planning to enroll in: a) a trial testing medication for managing OUD during pregnancy; b) research testing an intervention for substance use disorder or NAS (Neonatal Abstinence Syndrome) in their infant unless they are willing to provide a release for the research records.