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Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03740243
Recruitment Status : Withdrawn (No enrollment)
First Posted : November 14, 2018
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
David Garry DO, Stony Brook University

Study Description
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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


Condition or disease Intervention/treatment Phase
Opioid-use Disorder Drug: Buprenorphine/naloxone Drug: Buprenorphine Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology
Actual Study Start Date : November 30, 2018
Actual Primary Completion Date : March 22, 2020
Actual Study Completion Date : March 22, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: buprenorphine

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+

 Drug: Buprenorphine
Buprenorphine tablet
Other Name: subutex, belbuca, butrans,sublocade
Experimental: buprenorphine/naloxone

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+

 Drug: Buprenorphine/naloxone
Buprenorphine/naloxone tablet or film
Other Name: suboxone, bunavail, zubsolv


Outcome Measures
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Primary Outcome Measures :
  1. Compliance antepartum [ Time Frame: From entry into the study until delivery (through study completion, an average of 9 months which is duration of the pregnancy) ]
    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.

  2. Compliance postpartum [ Time Frame: 2 month period 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).

  3. Dosing antepartum [ Time Frame: From entry into the study until delivery (through study completion, an average of 9 months which is duration of the pregnancy) ]
    Evaluate all women for the need a significant dosing change in buprenorphine or buprenorphine/naloxone (>50% increase or decrease) during pregnancy.

  4. Dosing postpartum [ Time Frame: 2 month period 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 :
  1. Maternal Outcomes Withdraw Scoring [ Time Frame: Duration of pregnancy and 2 months of postpartum period ]

    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


  2. Maternal Outcome Metabolites [ Time Frame: At delivery of newborn ]
    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)

  3. Placental dysmaturity [ Time Frame: At delivery of newborn ]
    Placental histology (obtained at delivery - pathology specimen)

  4. Neonatal Outcomes [ Time Frame: Birth until discharge from hospital (performed during hospitalization of newborn from 0 to 30 days of life) ]
    Neonatal Abstinence Syndrome (NAS) rate

  5. Neonatal stay [ Time Frame: Birth to newborn discharge home (from day 0 through 120 days of life) ]
    Duration of newborn inpatient hospital stay

  6. Newborn [ Time Frame: At birth ]
    Gestational age at birth (range 23 to 43 weeks)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   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.
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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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): NCT03740243


Sponsors and Collaborators
Stony Brook University
Investigators
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Principal Investigator: David J Garry, DO Stony Brook University
  Study Documents (Full-Text)

Documents provided by David Garry DO, Stony Brook University:
Study Protocol and Statistical Analysis Plan: Protocol and SAP  [PDF] August 27, 2018
Informed Consent Form  [PDF] August 27, 2018
Study Protocol: COWS questionnaire and Brief Substance Cravings scale  [PDF] August 28, 2018

More Information
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Publications of Results:

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Responsible Party: David Garry DO, Director, Maternal Fetal Medicine, Stony Brook University
ClinicalTrials.gov Identifier: NCT03740243    
Other Study ID Numbers: 1175806
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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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
Keywords provided by David Garry DO, Stony Brook University:
opioid use disorder
Buprenorphine/naloxone
Buprenorphine
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naloxone
Analgesics, Opioid
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists