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
  Purpose

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.


Condition Intervention Phase
Opioid Related Disorders
Pregnancy
Opioid Dependence
Drug: Methadone
Drug: Buprenorphine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Maternal Opioid Treatment: Human Experimental Research

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 175
Study Start Date: July 2005
Study Completion Date: June 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: B
Buprenorphine
Drug: Buprenorphine
sl daily 2-32 mg
Active Comparator: A
Methadone
Drug: Methadone
daily oral dosing 20-140 mg

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.

  Eligibility

Ages Eligible for Study:   18 Years to 41 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271219

Locations
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21224
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48207
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02912
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
Austria
Medical University of Vienna
Vienna, Austria, A1090
Canada, Ontario
St. Joseph's Health Centre
Toronto, Ontario, Canada, M6R 1B5
Sponsors and Collaborators
Investigators
Principal Investigator: Hendree E. Jones, PhD Johns Hopkins University
  More Information

No publications provided by National Institute on Drug Abuse (NIDA)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hendree E. Jones, Professor, Dept of Psychiatry and Behavioral Sciences, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00271219     History of Changes
Other Study ID Numbers: R01DA15764-1, R01DA15764-1, DPMC
Study First Received: December 28, 2005
Last Updated: October 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):
opiate addiction
opiate dependence
substance abuse
addiction
substance addiction
pregnancy
buprenorphine
methadone
fetal
neonatal
post-partum

Additional relevant MeSH terms:
Opioid-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Buprenorphine
Methadone
Analgesics
Analgesics, Opioid
Antitussive Agents
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014