RCT Comparing Methadone and Buprenorphine in Pregnant Women

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.

Inclusion Criteria:

- Current opioid dependence

- Current opioid use, as determined by a urine drug test

- Pregnant with a single child with a gestational age of 6 to 30 weeks, as determined
by a sonogram

Exclusion Criteria:

- Current medical condition that would make study participation dangerous, as
determined by study physician

- Diagnosed with an acute, severe psychiatric illness

- Current SCID I-E module diagnosis of benzodiazepine or alcohol abuse

- Use of alcohol or benzodiazepines in the 30 days prior to study entry, as determined
by the Addiction Severity Index

- Pending legal action that may prohibit or interfere with study participation