RCT Comparing Methadone and Buprenorphine in Pregnant Women
2015年7月30日 更新者：Hendree E. Jones、Johns Hopkins University
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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
175
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Maryland
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Baltimore、Maryland、アメリカ、21224
- Johns Hopkins University School of Medicine
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Michigan
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Detroit、Michigan、アメリカ、48207
- Wayne State University
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19107
- Thomas Jefferson University
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Rhode Island
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Providence、Rhode Island、アメリカ、02912
- Brown University
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Tennessee
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Nashville、Tennessee、アメリカ、37232
- Vanderbilt University
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Vermont
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Burlington、Vermont、アメリカ、05401
- University of Vermont
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Vienna、オーストリア、A1090
- Medical University of Vienna
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Ontario
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Toronto、Ontario、カナダ、M6R 1B5
- St. Joseph's Health Centre
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～41年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：ブプレノルフィン
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sl daily 2-32 mg
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アクティブコンパレータ：Methadone
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daily oral dosing 20-140 mg
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Child's Head Circumference Measurement (Measured at Birth)
時間枠：birth
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birth
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Child's Length of Hospital Stay
時間枠：delivery until hospital discharge (min=2 days, max=79 days)
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delivery until hospital discharge (min=2 days, max=79 days)
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Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS)
時間枠：From birth until hospital discharge (min=4 days, max=10, depending on site)
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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.
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From birth until hospital discharge (min=4 days, max=10, depending on site)
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Child's Peak Daily Total NAS Score
時間枠：minimum twice daily from birth until NAS no longer measured (min=10 days)
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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.
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minimum twice daily from birth until NAS no longer measured (min=10 days)
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Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS
時間枠：Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days)
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Total amount in mg
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Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Mother's Self-report of Drug Use (Measured Monthly by Time Line Follow Back)
時間枠：monthly from study entry until discontinuation or delivery (min=29 days, max=239 days)
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monthly from study entry until discontinuation or delivery (min=29 days, max=239 days)
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Mother's HIV Risk Behaviors (Measured Monthly by Risk Behavior Assessment)
時間枠：monthly from study entry until discontinuation or delivery (min=29 days, max=239 days)
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monthly from study entry until discontinuation or delivery (min=29 days, max=239 days)
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Mother's Measures of Dose Adequacy and Acceptance Over Time (Measured Weekly by Dose Adequacy Measure)
時間枠：from study entry until discontinuation or delivery (min=29 days, max=239 days)
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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.
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from study entry until discontinuation or delivery (min=29 days, max=239 days)
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Mother's Psychosocial Functioning at Delivery as Measured by the Addiction Severity Index Psychosocial Index Score
時間枠：at delivery
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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.
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at delivery
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Hendree E. Jones, PhD、Johns Hopkins University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Jones HE, Kaltenbach K, Heil SH, Stine SM, Coyle MG, Arria AM, O'Grady KE, Selby P, Martin PR. Nonserious adverse events in randomized trials with opioid-dependent pregnant women: direct versus indirect measurement. Am J Addict. 2012 Nov;21 Suppl 1:S1-4. doi: 10.1111/j.1521-0391.2012.00289.x.
- Holbrook AM, Jones HE, Heil SH, Martin PR, Stine SM, Fischer G, Coyle MG, Kaltenbach K. Induction of pregnant women onto opioid-agonist maintenance medication: an analysis of withdrawal symptoms and study retention. Drug Alcohol Depend. 2013 Sep 1;132(1-2):329-34. doi: 10.1016/j.drugalcdep.2013.02.031. Epub 2013 Mar 21.
- Jones HE, Heil SH, Tuten M, Chisolm MS, Foster JM, O'Grady KE, Kaltenbach K. Cigarette smoking in opioid-dependent pregnant women: neonatal and maternal outcomes. Drug Alcohol Depend. 2013 Aug 1;131(3):271-7. doi: 10.1016/j.drugalcdep.2012.11.019. Epub 2012 Dec 29.
- McNicholas LF, Holbrook AM, O'Grady KE, Jones HE, Coyle MG, Martin PR, Heil SH, Stine SM, Kaltenbach K. Effect of hepatitis C virus status on liver enzymes in opioid-dependent pregnant women maintained on opioid-agonist medication. Addiction. 2012 Nov;107 Suppl 1(0 1):91-7. doi: 10.1111/j.1360-0443.2012.04043.x.
- Holbrook AM, Baxter JK, Jones HE, Heil SH, Coyle MG, Martin PR, Stine SM, Kaltenbach K. Infections and obstetric outcomes in opioid-dependent pregnant women maintained on methadone or buprenorphine. Addiction. 2012 Nov;107 Suppl 1(Suppl 1):83-90. doi: 10.1111/j.1360-0443.2012.04042.x.
- Benningfield MM, Dietrich MS, Jones HE, Kaltenbach K, Heil SH, Stine SM, Coyle MG, Arria AM, O'Grady KE, Fischer G, Martin PR. Opioid dependence during pregnancy: relationships of anxiety and depression symptoms to treatment outcomes. Addiction. 2012 Nov;107 Suppl 1(0 1):74-82. doi: 10.1111/j.1360-0443.2012.04041.x.
- Coyle MG, Salisbury AL, Lester BM, Jones HE, Lin H, Graf-Rohrmeister K, Fischer G. Neonatal neurobehavior effects following buprenorphine versus methadone exposure. Addiction. 2012 Nov;107 Suppl 1(0 1):63-73. doi: 10.1111/j.1360-0443.2012.04040.x.
- Gaalema DE, Scott TL, Heil SH, Coyle MG, Kaltenbach K, Badger GJ, Arria AM, Stine SM, Martin PR, Jones HE. Differences in the profile of neonatal abstinence syndrome signs in methadone- versus buprenorphine-exposed neonates. Addiction. 2012 Nov;107 Suppl 1(0 1):53-62. doi: 10.1111/j.1360-0443.2012.04039.x.
- Kaltenbach K, Holbrook AM, Coyle MG, Heil SH, Salisbury AL, Stine SM, Martin PR, Jones HE. Predicting treatment for neonatal abstinence syndrome in infants born to women maintained on opioid agonist medication. Addiction. 2012 Nov;107 Suppl 1(0 1):45-52. doi: 10.1111/j.1360-0443.2012.04038.x.
- Salisbury AL, Coyle MG, O'Grady KE, Heil SH, Martin PR, Stine SM, Kaltenbach K, Weninger M, Jones HE. Fetal assessment before and after dosing with buprenorphine or methadone. Addiction. 2012 Nov;107 Suppl 1(0 1):36-44. doi: 10.1111/j.1360-0443.2012.04037.x.
- Jones HE, Fischer G, Heil SH, Kaltenbach K, Martin PR, Coyle MG, Selby P, Stine SM, O'Grady KE, Arria AM. Maternal Opioid Treatment: Human Experimental Research (MOTHER)--approach, issues and lessons learned. Addiction. 2012 Nov;107 Suppl 1(0 1):28-35. doi: 10.1111/j.1360-0443.2012.04036.x.
- Jones HE, Heil SH, Baewert A, Arria AM, Kaltenbach K, Martin PR, Coyle MG, Selby P, Stine SM, Fischer G. Buprenorphine treatment of opioid-dependent pregnant women: a comprehensive review. Addiction. 2012 Nov;107 Suppl 1(0 1):5-27. doi: 10.1111/j.1360-0443.2012.04035.x.
- Unger A, Jagsch R, Bawert A, Winklbaur B, Rohrmeister K, Martin PR, Coyle M, Fischer G. Are male neonates more vulnerable to neonatal abstinence syndrome than female neonates? Gend Med. 2011 Dec;8(6):355-64. doi: 10.1016/j.genm.2011.10.001. Epub 2011 Nov 15.
- Jones HE, Kaltenbach K, Heil SH, Stine SM, Coyle MG, Arria AM, O'Grady KE, Selby P, Martin PR, Fischer G. Neonatal abstinence syndrome after methadone or buprenorphine exposure. N Engl J Med. 2010 Dec 9;363(24):2320-31. doi: 10.1056/NEJMoa1005359.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2005年7月1日
一次修了 (実際)
2009年8月1日
研究の完了 (実際)
2010年6月1日
試験登録日
最初に提出
2005年12月28日
QC基準を満たした最初の提出物
2005年12月28日
最初の投稿 (見積もり)
2005年12月30日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年8月5日
QC基準を満たした最後の更新が送信されました
2015年7月30日
最終確認日
2015年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。