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RCT Comparing Methadone and Buprenorphine in Pregnant Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hendree E. Jones, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00271219
First received: December 28, 2005
Last updated: October 19, 2012
Last verified: October 2012
History of Changes

December 28, 2005
October 19, 2012
July 2005
August 2009   (final data collection date for primary outcome measure)
  • Child's head circumference measurement (measured at birth) [ Time Frame: birth ] [ Designated as safety issue: Yes ]
  • Child's length of hospital stay [ Time Frame: delivery until hospital d/c ] [ Designated as safety issue: Yes ]
  • Number of children requiring treatment for Neonatal Abstinence Signs (NAS) [ Time Frame: from birth until no treatment ] [ Designated as safety issue: Yes ]
  • Child's peak daily total NAS score [ Time Frame: from birth until NS no longer measured ] [ Designated as safety issue: Yes ]
  • Total amount of withdrawal medication child receives [ Time Frame: from start of NAS treatment until discontinuation of NAS treatment ] [ Designated as safety issue: Yes ]
  • Child's head circumference measurement (measured at birth)
  • Child's length of hospital stay
  • Number of children requiring treament for Neonatal Abstinence Signs (NAS)
  • Child's peak daily total NAS score
  • Total amount of withdrawal medication child receives
Complete list of historical versions of study NCT00271219 on ClinicalTrials.gov Archive Site
  • Mother's self-report of drug use (measured monthly by Time Line Follow Back) [ Time Frame: course of study participations ] [ Designated as safety issue: No ]
  • Mother's HIV risk behaviors (measured monthly by Risk Behavior Assessment) [ Time Frame: from start to end of study participation ] [ Designated as safety issue: Yes ]
  • Mother's measures of dose adequacy and acceptance over time (measured weekly by Dose Adequacy Questionnaire) [ Time Frame: from start to end of study participation ] [ Designated as safety issue: No ]
  • Mother's psychosocial functioning (measured monthly by Addiction Severity Index and SCID) [ Time Frame: measured at intake and monthly during study participation ] [ Designated as safety issue: No ]
  • 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)
Not Provided
Not Provided
 
RCT Comparing Methadone and Buprenorphine in Pregnant Women
Maternal Opioid Treatment: Human Experimental Research

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Opioid Related Disorders
  • Pregnancy
  • Opioid Dependence
  • Drug: Methadone
    daily oral dosing 20-140 mg
  • Drug: Buprenorphine
    sl daily 2-32 mg
  • Experimental: B
    Buprenorphine
    Intervention: Drug: Buprenorphine
  • Active Comparator: A
    Methadone
    Intervention: Drug: Methadone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
175
June 2010
August 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 41 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Canada
 
NCT00271219
R01DA15764-1, R01DA15764-1, DPMC
Yes
Hendree E. Jones, National Institute on Drug Abuse (NIDA)
National Institute on Drug Abuse (NIDA)
Not Provided
Principal Investigator: Hendree E. Jones, PhD Johns Hopkins University
National Institute on Drug Abuse (NIDA)
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP