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Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology

Primary Purpose

Opioid-use Disorder

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Buprenorphine/naloxone
Buprenorphine
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-use Disorder focused on measuring opioid use disorder, Buprenorphine/naloxone, Buprenorphine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years of age and older
  • With a confirmed viable intrauterine pregnancy
  • Opioid Use Disorder
  • Care in a Stony Brook Medicine OBGYN clinical office sites
  • Medication-assisted treatment through Stony Brook Medicine OBGYN office sites

Exclusion Criteria:

  • Known or suspected allergy to buprenorphine or buprenorphine/naloxone
  • Carrying a fetus with known aneuploidy or anomaly

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    buprenorphine

    buprenorphine/naloxone

    Arm Description

    Buprenorphine 2 mg to 8 mg daily: Light to moderate history of opioid use (heroin, oxycodone, etc.) and/or Clinical Opioid Withdraw Scale (COWS) scores 5-24 Buprenorphine 8 mg to 16 mg daily: Heavy history of opioid use (heroin, oxycodone, etc.) and/or Clinical Opioid Withdraw Scale (COWS) scores 25-36+

    Buprenorphine/naloxone 4 mg/1 mg daily once daily or twice daily (BID): Light to moderate history of opioid use (heroin, oxycodone, etc.) and/or Clinical Opioid Withdraw Scale (COWS) scores 5-24 Buprenorphine/naloxone 8 mg/2 mg daily once daily or twice daily (BID): Heavy history of opioid use (heroin, oxycodone, etc.) and/or Clinical Opioid Withdraw Scale (COWS) scores 25-36+

    Outcomes

    Primary Outcome Measures

    Compliance antepartum
    To compare compliance with buprenorphine versus buprenorphine/naloxone medication-assisted treatment (MAT) in pregnant women. Compliance will include the incidence of urine toxicology testing positive for illicit substances during prenatal care and at the time of admission for delivery.
    Compliance postpartum
    To compare compliance with buprenorphine versus buprenorphine/naloxone medication-assisted treatment (MAT) in the postpartum period. Compliance will include the incidence of urine toxicology testing positive for illicit substances from the time of discharge from the hospital following the delivery over a 2 month period postpartum (postpartum period).
    Dosing antepartum
    Evaluate all women for the need a significant dosing change in buprenorphine or buprenorphine/naloxone (>50% increase or decrease) during pregnancy.
    Dosing postpartum
    Evaluate all women for the need a significant dosing change in buprenorphine or buprenorphine/naloxone (>50% increase or decrease) from the hospital following the delivery over a 2 month period postpartum (postpartum period).

    Secondary Outcome Measures

    Maternal Outcomes Withdraw Scoring
    Prenatal Clinical Opioid Withdraw Scale (COWS) score and drug cravings score (0 to 48 score) Score interpretation: 5-12 = Mild 13-24 = Moderate 25-36 = Moderately Severe More than 36 = Severe Withdrawal
    Maternal Outcome Metabolites
    Umbilical cord blood levels of metabolites of buprenorphine (norbuprenorphine, buprenorphine glucuronide, and norbuprenorphine glucuronide) which are obtained from the umbilical cord after delivery of the baby (one time specimen for evaluation)
    Placental dysmaturity
    Placental histology (obtained at delivery - pathology specimen)
    Neonatal Outcomes
    Neonatal Abstinence Syndrome (NAS) rate
    Neonatal stay
    Duration of newborn inpatient hospital stay
    Newborn
    Gestational age at birth (range 23 to 43 weeks)

    Full Information

    First Posted
    October 15, 2018
    Last Updated
    March 22, 2020
    Sponsor
    Stony Brook University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03740243
    Brief Title
    Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology
    Official Title
    Comparison of Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No enrollment
    Study Start Date
    November 30, 2018 (Actual)
    Primary Completion Date
    March 22, 2020 (Actual)
    Study Completion Date
    March 22, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stony Brook University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study will assesses the efficacy of buprenorphine/naloxone vs buprenorphine on maternal withdrawal symptoms and drug cravings. This is a randomized controlled trial to a cohort of pregnant women seeking medication-assisted treatment for opioid use disorders. Half of participants will receive buprenorphine, while the other half of participants receive a combination of buprenorphine/naloxone
    Detailed Description
    Buprenorphine and Buprenorphine/naloxone each are used to treat opioid use disorders in pregnancy. Buprenorphine has many preferential characteristics over methadone including decreased risk of maternal overdose, lower incidence of preterm labor, less frequent clinical visits, shorter duration of neonatal hospital stay and treatment for neonatal abstinence syndrome. Recent studies have found that increasing the dosing frequencies of buprenorphine is more efficacious to prevent maternal withdrawal symptoms, improve compliance, and theoretically produce better pregnancy outcomes. Buprenorphine/naloxone, a combination opioid of buprenorphine and naloxone, has also been investigated as an alternative to treatment and maintenance for opioid use disorder. The advantage of the combination of buprenorphine with naloxone is that it reduces the potential for abuse. As a partial mu opioid agonist, buprenorphine alone has the capacity to induce typical opioid effects such as euphoria, which are enhanced when the drug is taken intravenously. By combining buprenorphine with naloxone, an opioid antagonist, the capacity for buprenorphine to be abused is reduced.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Opioid-use Disorder
    Keywords
    opioid use disorder, Buprenorphine/naloxone, Buprenorphine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    buprenorphine
    Arm Type
    Active Comparator
    Arm Description
    Buprenorphine 2 mg to 8 mg daily: Light to moderate history of opioid use (heroin, oxycodone, etc.) and/or Clinical Opioid Withdraw Scale (COWS) scores 5-24 Buprenorphine 8 mg to 16 mg daily: Heavy history of opioid use (heroin, oxycodone, etc.) and/or Clinical Opioid Withdraw Scale (COWS) scores 25-36+
    Arm Title
    buprenorphine/naloxone
    Arm Type
    Experimental
    Arm Description
    Buprenorphine/naloxone 4 mg/1 mg daily once daily or twice daily (BID): Light to moderate history of opioid use (heroin, oxycodone, etc.) and/or Clinical Opioid Withdraw Scale (COWS) scores 5-24 Buprenorphine/naloxone 8 mg/2 mg daily once daily or twice daily (BID): Heavy history of opioid use (heroin, oxycodone, etc.) and/or Clinical Opioid Withdraw Scale (COWS) scores 25-36+
    Intervention Type
    Drug
    Intervention Name(s)
    Buprenorphine/naloxone
    Other Intervention Name(s)
    suboxone, bunavail, zubsolv
    Intervention Description
    Buprenorphine/naloxone tablet or film
    Intervention Type
    Drug
    Intervention Name(s)
    Buprenorphine
    Other Intervention Name(s)
    subutex, belbuca, butrans,sublocade
    Intervention Description
    Buprenorphine tablet
    Primary Outcome Measure Information:
    Title
    Compliance antepartum
    Description
    To compare compliance with buprenorphine versus buprenorphine/naloxone medication-assisted treatment (MAT) in pregnant women. Compliance will include the incidence of urine toxicology testing positive for illicit substances during prenatal care and at the time of admission for delivery.
    Time Frame
    From entry into the study until delivery (through study completion, an average of 9 months which is duration of the pregnancy)
    Title
    Compliance postpartum
    Description
    To compare compliance with buprenorphine versus buprenorphine/naloxone medication-assisted treatment (MAT) in the postpartum period. Compliance will include the incidence of urine toxicology testing positive for illicit substances from the time of discharge from the hospital following the delivery over a 2 month period postpartum (postpartum period).
    Time Frame
    2 month period postpartum
    Title
    Dosing antepartum
    Description
    Evaluate all women for the need a significant dosing change in buprenorphine or buprenorphine/naloxone (>50% increase or decrease) during pregnancy.
    Time Frame
    From entry into the study until delivery (through study completion, an average of 9 months which is duration of the pregnancy)
    Title
    Dosing postpartum
    Description
    Evaluate all women for the need a significant dosing change in buprenorphine or buprenorphine/naloxone (>50% increase or decrease) from the hospital following the delivery over a 2 month period postpartum (postpartum period).
    Time Frame
    2 month period postpartum
    Secondary Outcome Measure Information:
    Title
    Maternal Outcomes Withdraw Scoring
    Description
    Prenatal Clinical Opioid Withdraw Scale (COWS) score and drug cravings score (0 to 48 score) Score interpretation: 5-12 = Mild 13-24 = Moderate 25-36 = Moderately Severe More than 36 = Severe Withdrawal
    Time Frame
    Duration of pregnancy and 2 months of postpartum period
    Title
    Maternal Outcome Metabolites
    Description
    Umbilical cord blood levels of metabolites of buprenorphine (norbuprenorphine, buprenorphine glucuronide, and norbuprenorphine glucuronide) which are obtained from the umbilical cord after delivery of the baby (one time specimen for evaluation)
    Time Frame
    At delivery of newborn
    Title
    Placental dysmaturity
    Description
    Placental histology (obtained at delivery - pathology specimen)
    Time Frame
    At delivery of newborn
    Title
    Neonatal Outcomes
    Description
    Neonatal Abstinence Syndrome (NAS) rate
    Time Frame
    Birth until discharge from hospital (performed during hospitalization of newborn from 0 to 30 days of life)
    Title
    Neonatal stay
    Description
    Duration of newborn inpatient hospital stay
    Time Frame
    Birth to newborn discharge home (from day 0 through 120 days of life)
    Title
    Newborn
    Description
    Gestational age at birth (range 23 to 43 weeks)
    Time Frame
    At birth

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    As this study pertains only to pregnant patients seeking treatment for opioid use disorders, females are the only biologically plausiable participants.
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18 years of age and older With a confirmed viable intrauterine pregnancy Opioid Use Disorder Care in a Stony Brook Medicine OBGYN clinical office sites Medication-assisted treatment through Stony Brook Medicine OBGYN office sites Exclusion Criteria: Known or suspected allergy to buprenorphine or buprenorphine/naloxone Carrying a fetus with known aneuploidy or anomaly
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David J Garry, DO
    Organizational Affiliation
    Stony Brook University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    In regards to the participants and neonates' health information, care will be taken to ensure privacy. All data and specimens will be coded with a case number and de-identified, and exported to a REDcap application system (secure data file approved by Institutional Review Board). The REDcap application data will be kept on the department's secure, shared institutional, server space.
    Citations:
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    28742676
    Citation
    Committee Opinion No. 711: Opioid Use and Opioid Use Disorder in Pregnancy. Obstet Gynecol. 2017 Aug;130(2):e81-e94. doi: 10.1097/AOG.0000000000002235.
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    Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology

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