Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Long Acting Subcutaneous vs Short Acting Sublingual Buprenorphine in Pregnant and Lactating Women

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: NCT04212065
Recruitment Status : Withdrawn (closed due to new safety concerns of subcutaneous buprenorphine in pregnant patients)
First Posted : December 26, 2019
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Kara M Rood, MD, Ohio State University

Brief Summary:
This is a non-inferiority, open label, randomized trial of women on buprenorphine Medication Assisted Therapy for opioid use disorder in pregnancy.Patients will be randomized to either the long acting monthly subcutaneous SublocadeTM or to short acting sublingual Suboxone®.

Condition or disease Intervention/treatment Phase
Opioid Use Disorder Drug: buprenorphine Phase 4

Detailed Description:
Opioid use disorder increased among pregnant women in recent years, despite an overall decrease in the general population in the same time frame. Given the increased use of buprenorphine for opioid use disorder, it has now become the most commonly misused prescription opioid subtype. Untreated opioid use disorder is associated with worse maternal, fetal, and neonatal outcomes. To improve compliance with medication assisted therapy, decrease relapse and neonatal abstinence syndrome, we propose a randomized control trial of long acting subcutaneous buprenorphine compared to short acting sublingual buprenorphine/naloxone administration in pregnant and lactating women.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This study is a randomized, non-blinded single center clinical trial conducted at Ohio State University (OSU) Wexner Medical Center of 139 women with diagnosed Opioid Use Disorder. These women will be randomized between 14 and 27 weeks to one of two groups:

  • Sublingual Suboxone® 8mg twice daily
  • Subcutaneous SublocadeTM of 300mg monthly
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long Acting Subcutaneous Compared to Short Acting Sublingual Buprenorphine Administration in Pregnant and Lactating Women
Actual Study Start Date : February 21, 2020
Actual Primary Completion Date : September 1, 2020
Actual Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sublingual Suboxone
Women randomized to sublingual dosing will be provided prescription to fill.
Drug: buprenorphine
To improve compliance with medication assisted therapy, decrease relapse and neonatal abstinence syndrome, we propose a randomized control trial of long acting subcutaneous buprenorphine compared to short acting sublingual buprenorphine/naloxone administration in pregnant and lactating women.
Other Name: Sublocade, Suboxone

Active Comparator: Subcutaneous Sublocade
Women randomized to subcutaneous administration will have drug administered by nurse during routine prenatal care visits.
Drug: buprenorphine
To improve compliance with medication assisted therapy, decrease relapse and neonatal abstinence syndrome, we propose a randomized control trial of long acting subcutaneous buprenorphine compared to short acting sublingual buprenorphine/naloxone administration in pregnant and lactating women.
Other Name: Sublocade, Suboxone




Primary Outcome Measures :
  1. Evaluating the compliance with prescribed medication is not inferior in women assigned to SublocadeTM compared with those to Suboxone®. [ Time Frame: Through study completion, an average of 1.5 years ]
    Compliance will be assessed by urine drug screens during pregnancy and postpartum visits that are positive for buprenorphine, with assessment of the number of drug screens which are negative for illicit drugs out of the total collected during the study period, with a minimum of three drug screens collected.


Secondary Outcome Measures :
  1. Evaluating concentration of buprenorphine and metabolites in maternal plasma [ Time Frame: Enrollment through four weeks postpartum ]
    o A weekly blood draw will be collected, with evaluation of drug concentrations at approximate trough and peak levels before and after drug administration. The blood draw around the time of delivery will evaluate the association between drug concentration and neonatal opioid withdrawal syndrome outcomes.

  2. Evaluating concentration of buprenorphine and metabolites in cord plasma [ Time Frame: Delivery ]
    Cord blood will be collected and used to estimate fetal exposure to buprenorphine

  3. Evaluating concentration of buprenorphine and metabolites in breast milk [ Time Frame: 1-6 months postpartum ]
    Breast milk will be collected and used to estimate infant exposure to buprenorphine via breast milk



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only pregnant women with opioid use disorder
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-41 years
  • Women with a viable singleton or twin intrauterine pregnancy between 14 0/7 and 27 6/7 weeks gestation based on the best obstetric estimate by ACOG (The American College of Obstetricians and Gynecologists) criteria, and are not planning to terminate the pregnancy.
  • Diagnosis of moderate to severe Opioid Use Disorder (OUD), as defined by DSM-V criteria. Mild OUD is defined as 2-3 of the following present, moderate OUD with 4-5 of the following present, and severe OUD with 6 or more of the following present:

    • Substance is often taken in larger amounts and/or over a longer period than the patient intended.
    • Persistent attempts or one or more unsuccessful efforts made to cut down or control substance use.
    • A great deal of time is spent in activities necessary to obtain the substance, use the substance, or recover from effects.
    • Craving or strong desire or urge to use the substance
    • Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home.
    • Continued substance use despite having persistent or recurrent social or interpersonal problem caused or exacerbated by the effects of the substance.
    • Important social, occupational or recreational activities given up or reduced because of substance use.
    • Recurrent substance use in situations in which it is physically hazardous.
    • Substance use is continued despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance.

The diagnosis and the diagnostic criteria will be recorded.

  • Willing to be randomized to subcutaneous or sublingual buprenorphine and to comply with study procedures, including weekly Medication Check Visits
  • Planning to deliver at OSU Wexner Medical Center
  • Enrolled in prenatal outpatient addiction treatment at OSU
  • Able to understand the study, and having understood, provide written informed consent in English

Exclusion Criteria:

  • Known allergy or adverse reaction to buprenorphine
  • Abnormal obstetrical ultrasound suspicious for major congenital abnormality
  • Known or suspected fetal aneuploidy (by either CVS (Chorionic Villus Sampling), amniocentesis or cell-free DNA)
  • Participation in another trial that may influence the primary outcome, without prior approval
  • Participation in this trial in a prior pregnancy
  • Higher order pregnancy
  • Have a physiological dependence on alcohol or sedatives requiring medical detoxification
  • Have a psychiatric condition that, in the judgment of the site medical clinician (MC), would make study participation unsafe or which would make treatment compliance difficult. Examples include:

    • Suicidal or homicidal ideation requiring immediate attention
    • Severe, inadequately-treated mental health disorder (e.g., active psychosis, uncontrolled bipolar disorder)
  • Have a medical condition that, in the judgment of the study MC, would make study participation unsafe or which would make treatment compliance difficult. Medical conditions that may compromise participant safety or study conduct include, but are not limited to, allergy/sensitivity to study medications and the following based on clinical labs:

    • aspartate aminotransferase (AST) / alanine aminotransferase (ALT) greater than 5X upper limit of normal
    • serum creatinine greater than 1.5X upper limit of normal
    • total bilirubin greater than 1.5X upper limit of normal
  • Currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or other situation (e.g., unstable living arrangements) that, in the judgement of the site investigator, could prevent participation in the study or in any study activities;
  • Currently receiving methadone or naltrexone for the treatment of OUD;
  • Enrolled in or planning to enroll in treatment beyond the level of 3.1 (clinically managed low-intensity residential services) of the American Society of Addiction Medicine criteria
  • Enrolled in or planning to enroll in: a) a trial testing medication for managing OUD during pregnancy; b) research testing an intervention for substance use disorder or NAS (Neonatal Abstinence Syndrome) in their infant unless they are willing to provide a release for the research records.

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): NCT04212065


Locations
Layout table for location information
United States, Ohio
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Layout table for investigator information
Principal Investigator: Kara Rood, MD Ohio State University
Layout table for additonal information
Responsible Party: Kara M Rood, MD, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT04212065    
Other Study ID Numbers: 2019H0354
First Posted: December 26, 2019    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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.: No
Keywords provided by Kara M Rood, MD, Ohio State University:
Sublocade
Suboxone
Additional relevant MeSH terms:
Layout table for MeSH terms
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists