RCT Comparing Methadone and Buprenorphine in Pregnant Women

Condition(s) targeted: Opioid Related Disorders; Pregnancy; Opioid Dependence

Intervention: Methadone (Drug); Buprenorphine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: National Institute on Drug Abuse (NIDA)

Official(s) and/or principal investigator(s):
Hendree E. Jones, PhD, Principal Investigator, Affiliation: Johns Hopkins University

Overall contact:
Hendree E. Jones, PhD, Phone: 410-917-9084, Email: hejones@jhmi.edu

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.

Official title: Maternal Opioid Treatment: Human Experimental Research

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Child's head circumference measurement (measured at birth)

Child's length of hospital stay

Number of children requiring treatment for Neonatal Abstinence Signs (NAS)

Child's peak daily total NAS score

Total amount of withdrawal medication child receives

Secondary outcome:

Mother's self-report of drug use (measured monthly by Time Line Follow Back)

Mother's HIV risk behaviors (measured monthly by Risk Behavior Assessment)

Mother's measures of dose adequacy and acceptance over time (measured weekly by Dose Adequacy Questionnaire)

Mother's psychosocial functioning (measured monthly by Addiction Severity Index and SCID)

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.

Minimum age: 18 Years. Maximum age: 41 Years. Gender(s): Female.

Criteria:

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

Hendree E. Jones, PhD, Phone: 410-917-9084, Email: hejones@jhmi.edu

Medical University of Vienna, Vienna A1090, Austria; Recruiting
Gabriele Fischer, Phone: 9.011.431.40400.3600, Email: gabriele.fischer@meduniwien.ac.at
Bernadette Winklbaur, Phone: 9.011.431.40400.3576, Email: bernadette.winklbaur@meduniwien.ac.at

Johns Hopkins University School of Medicine, Baltimore, Maryland 21224, United States; Recruiting
Hendree E. Jones, PhD, Phone: 410-917-9084, Email: hejones@jhmi.edu

Wayne State University, Detroit, Michigan 48207, United States; Recruiting
Susan Stine, Phone: 313-993-9879, Email: sstine@med.wayne.edu

St. Joseph's Health Centre, Toronto, Ontario M6R 1B5, Canada; Recruiting
Alice Ordean, Phone: 416-535-8501, Ext: 6787, Email: ORDEAA@stjoe.on.ca
Alla Osadchy, Phone: 416.530.6000, Ext: x4434, Email: osadca@stjoe.on.ca

Thomas Jefferson University, Philadelphia, Pennsylvania 19107, United States; Recruiting
Karol Kaltenbach, PhD, Phone: 215-955-4068, Email: Karol.Kaltenbach@jefferson.edu
Amber Holbrook, Phone: 215.955.3792, Email: Amber.Holbrook@jefferson.edu

Brown University, Providence, Rhode Island 02912, United States; Recruiting
Barry M. Lester, Phone: 401-453-7640, Email: barry_lester@brown.edu

Vanderbilt University, Nashville, Tennessee 37232, United States; Recruiting
Peter R. Martin, Phone: 615-322-3527, Email: peter.martin@vanderbilt.edu

University of Vermont, Burlington, Vermont 05401, United States; Recruiting
Sarah H. Heil, PhD, Phone: 802-656-8712, Email: sarah.heil@uvm.edu
Teresa Scott, Ph.D., Phone: 802.656.8718, Email: Teresa.Scott@uvm.edu

Starting date: July 2005
Ending date: December 2010
Last updated: August 7, 2008