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RCT Comparing Methadone and Buprenorphine in Pregnant Women

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ClinicalTrials.gov Identifier: NCT00271219
Recruitment Status : Completed
First Posted : December 30, 2005
Results First Posted : August 5, 2015
Last Update Posted : August 5, 2015
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Hendree E. Jones, Johns Hopkins University

Brief 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.

Condition or disease Intervention/treatment Phase
Opioid Related Disorders Pregnancy Opioid Dependence Drug: Methadone Drug: Buprenorphine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Maternal Opioid Treatment: Human Experimental Research
Study Start Date : July 2005
Actual Primary Completion Date : August 2009
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Arm Intervention/treatment
Experimental: Buprenorphine
Drug: Buprenorphine
sl daily 2-32 mg

Active Comparator: Methadone
Drug: Methadone
daily oral dosing 20-140 mg

Primary Outcome Measures :
  1. Child's Head Circumference Measurement (Measured at Birth) [ Time Frame: birth ]
  2. Child's Length of Hospital Stay [ Time Frame: delivery until hospital discharge (min=2 days, max=79 days) ]
  3. Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS) [ Time Frame: From birth until hospital discharge (min=4 days, max=10, depending on site) ]
    Neonatal abstinence syndrome (NAS) characterized by hyperirritability of the central nervous system and dysfunction in the autonomic nervous system, gastrointestinal tract, and respiratory system.11 When left untreated, NAS can result in serious illness (e.g., diarrhea, feeding difficulties, weight loss, and seizures) and death.

  4. Child's Peak Daily Total NAS Score [ Time Frame: minimum twice daily from birth until NAS no longer measured (min=10 days) ]
    NAS was measured with the MOTHER NAS scale, which includes 28 items, 19 of which are used for scoring and medication decisions. Scores can range from 0 to 42, with higher scores indicating more severe withdrawal.

  5. Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS [ Time Frame: Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days) ]
    Total amount in mg

Secondary Outcome Measures :
  1. Mother's Self-report of Drug Use (Measured Monthly by Time Line Follow Back) [ Time Frame: monthly from study entry until discontinuation or delivery (min=29 days, max=239 days) ]
  2. Mother's HIV Risk Behaviors (Measured Monthly by Risk Behavior Assessment) [ Time Frame: monthly from study entry until discontinuation or delivery (min=29 days, max=239 days) ]
  3. Mother's Measures of Dose Adequacy and Acceptance Over Time (Measured Weekly by Dose Adequacy Measure) [ Time Frame: from study entry until discontinuation or delivery (min=29 days, max=239 days) ]
    Pregnant women maintained on an opioid agonist medication may require upward adjustment to their medication during the course of pregnant. The Dose Adequacy Measure represented a recordation of dosing adjustments during the course of the study.

  4. Mother's Psychosocial Functioning at Delivery as Measured by the Addiction Severity Index Psychosocial Index Score [ Time Frame: at delivery ]
    The Addiction Severity Index is a structured clinical interview that assesses problem severity in 7 areas of functioning: alcohol use, drug use, medical, legal, employment, psychosocial, and psychiatric status. Each area of functioning yields a composite scale score between 0 and 1, with higher scores indicating greater problem severity in that area. Only the psychosocial index was examined in this study.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00271219

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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
Medical University of Vienna
Vienna, Austria, A1090
Canada, Ontario
St. Joseph's Health Centre
Toronto, Ontario, Canada, M6R 1B5
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Hendree E. Jones, PhD Johns Hopkins University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hendree E. Jones, Professor, Dept of Psychiatry and Behavioral Sciences, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00271219    
Other Study ID Numbers: R01DA15764-1
R01DA015764 ( U.S. NIH Grant/Contract )
First Posted: December 30, 2005    Key Record Dates
Results First Posted: August 5, 2015
Last Update Posted: August 5, 2015
Last Verified: July 2015
Keywords provided by Hendree E. Jones, Johns Hopkins University:
opiate addiction
opiate dependence
substance abuse
substance addiction
Additional relevant MeSH terms:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Antitussive Agents
Respiratory System Agents