Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology

March 22, 2020 updated by: David Garry DO, Stony Brook University

Comparison of Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • suboxone, bunavail, zubsolv

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From entry into the study until delivery (through study completion, an average of 9 months which is duration of the pregnancy)
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).
2 month period postpartum
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.
From entry into the study until delivery (through study completion, an average of 9 months which is duration of the pregnancy)
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).
2 month period postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Duration of pregnancy and 2 months of postpartum period
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)
At delivery of newborn
Placental dysmaturity
Time Frame: At delivery of newborn
Placental histology (obtained at delivery - pathology specimen)
At delivery of newborn
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
Birth until discharge from hospital (performed during hospitalization of newborn from 0 to 30 days of life)
Neonatal stay
Time Frame: Birth to newborn discharge home (from day 0 through 120 days of life)
Duration of newborn inpatient hospital stay
Birth to newborn discharge home (from day 0 through 120 days of life)
Newborn
Time Frame: At birth
Gestational age at birth (range 23 to 43 weeks)
At birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Investigators

  • Principal Investigator: David J Garry, DO, Stony Brook University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 30, 2018

Primary Completion (ACTUAL)

March 22, 2020

Study Completion (ACTUAL)

March 22, 2020

Study Registration Dates

First Submitted

October 15, 2018

First Submitted That Met QC Criteria

November 9, 2018

First Posted (ACTUAL)

November 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 22, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1175806

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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