RCT Comparing Methadone and Buprenorphine in Pregnant Women
Condition: Opioid Related Disorders; Pregnancy; Opioid Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Children born to women who abuse drugs have a high risk of being born with birth defects and
      developmental problems. Methadone is a drug that is commonly used for treating opioid
      dependence. However, its use by a pregnant woman can cause severe withdrawal symptoms in a
      newborn because of the prenatal exposure. The purpose of this study is to evaluate the
      effectiveness of buprenorphine, another drug, versus methadone in reducing withdrawal
      symptoms in children born to opioid-dependent women.
    

Detailed description: 
      Women who use drugs during pregnancy place their unborn children at high risk for being born
      addicted to drugs. Such children may also be born with birth defects and may experience
      learning and behavioral problems. Methadone, a synthetic narcotic, is commonly prescribed to
      treat opioid addiction. It may not be an optimal solution for opioid-dependent pregnant
      women, however, because a large percentage of children born to women taking methadone
      experience severe drug withdrawal symptoms at birth that often require medical treatment.
      Common opioid withdrawal symptoms, described as neonatal abstinence syndrome (NAS) in babies,
      include tremors, irritability, sleep problems, seizures, dehydration, and fever.
      Buprenorphine is a medication that has been approved to treat opioid dependence in
      individuals who are not pregnant but has not been approved for pregnant individuals. Past
      research has shown that use of buprenorphine in pregnant women results in improved birth
      outcomes over methadone. The purpose of this study is to evaluate the effectiveness of
      buprenorphine versus methadone at reducing opioid withdrawal symptoms in babies born to
      opioid-dependent women.

      This study will enroll opioid-dependent pregnant women who are 13 to 30 weeks pregnant and
      will follow each woman and her child throughout the pregnancy until 6 weeks postpartum. All
      participants will undergo an initial screening that will last several hours. Participants
      will then be randomly assigned to receive either methadone or buprenorphine on a daily basis,
      and will be required to visit the clinic each day to receive their medication. Outcome
      measurements will be assessed at weekly study visits throughout the pregnancy, and will
      include drug use, HIV risk behaviors, medication dose adequacy and safety, treatment
      retention, and psychosocial functioning. Urine samples will be collected 3 times a week, and
      blood will be drawn throughout the pregnancy for safety monitoring. Outcome measurements
      related to the baby will include head circumference measurement, length of hospital stay,
      severity and frequency of withdrawal symptoms, and amount of medication needed to control
      withdrawal symptoms.
    

Intervention name(s): Methadone; Buprenorphine
Intervention type(s): Drug; Drug
Intervention description(s): daily oral dosing 20-140 mg; sl daily 2-32 mg
Intervention MeSH terms: Buprenorphine; Methadone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: opiate addiction; opiate dependence; substance abuse; addiction; substance addiction; pregnancy; buprenorphine; methadone; fetal; neonatal; post-partum