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

NCT04212065 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2019H0354
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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®.

Conditions

Opioid Use Disorder

Keywords

Sublocade; Suboxone

Outcome Measures

Primary Outcomes (1)

• Evaluating the compliance with prescribed medication is not inferior in women assigned to SublocadeTM compared with those to Suboxone®.

  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.

  Through study completion, an average of 1.5 years

Secondary Outcomes (3)

• Evaluating concentration of buprenorphine and metabolites in maternal plasma

  Enrollment through four weeks postpartum

• Evaluating concentration of buprenorphine and metabolites in cord plasma

  Delivery

• Evaluating concentration of buprenorphine and metabolites in breast milk

  1-6 months postpartum

Study Arms (2)

Sublingual Suboxone

ACTIVE COMPARATOR

Women randomized to sublingual dosing will be provided prescription to fill.

Drug: buprenorphine

Subcutaneous Sublocade

ACTIVE COMPARATOR

Women randomized to subcutaneous administration will have drug administered by nurse during routine prenatal care visits.

Drug: buprenorphine

Interventions

buprenorphine DRUG

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.

Also known as: Sublocade, Suboxone

Subcutaneous Sublocade; Sublingual Suboxone

Eligibility Criteria

• Age: 18 Years - 41 Years
• Gender Eligibility Details: Only pregnant women with opioid use disorder
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine; Sublocade; Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Naloxone; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Kara Rood, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 26, 2019
• Study Start: February 21, 2020
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)