Opioid Use DisorderPhase 4NCT04212065
Long Acting Subcutaneous vs Short Acting Sublingual Buprenorphine in Pregnant and Lactating Women
A Phase 4 study testing buprenorphine in people with Opioid Use Disorder, run by Ohio State University at 1 site in United States.
Trial 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®. Read more about this study
- Who is it for?
- Ages 18 to 41 years, women only
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- buprenorphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2020to 1 Sep 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 41 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, 43210
About this study
Official title: Long Acting Subcutaneous Compared to Short Acting Sublingual Buprenorphine Administration in Pregnant and Lactating Women
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®.
Read the 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.
- Conditions
- Opioid Use Disorder
- Being tested
- buprenorphine
- Keywords
- Sublocade, Suboxone
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
buprenorphineDrug
Also called Sublocade, Suboxone
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.
| Study group | Role | What they receive |
|---|---|---|
| Sublingual Suboxone | Active comparator | Women randomized to sublingual dosing will be provided prescription to fill. Receives: Drug: buprenorphine |
| Subcutaneous Sublocade | Active comparator | Women randomized to subcutaneous administration will have drug administered by nurse during routine prenatal care visits. Receives: Drug: buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1.5 years
Secondary outcomes (3)
Evaluating concentration of buprenorphine and metabolites in maternal plasma
- 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.
Measured: Enrollment through four weeks postpartum
Evaluating concentration of buprenorphine and metabolites in cord plasma
Cord blood will be collected and used to estimate fetal exposure to buprenorphine
Measured: Delivery
Evaluating concentration of buprenorphine and metabolites in breast milk
Breast milk will be collected and used to estimate infant exposure to buprenorphine via breast milk
Measured: 1-6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start21 Feb 2020
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Why it stopped: closed due to new safety concerns of subcutaneous buprenorphine in pregnant patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kara M Rood, MD, Ohio State University
- Investigators
- Kara Rood, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212065
- Sponsor's protocol ID
- 2019H0354
- Status last verified
- Oct 2020
- First submitted
- 19 Dec 2019
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Acting Subcutaneous Compared to Short Acting Sublingual Buprenorphine Administration in Pregnant and Lactating Women
- ClinicalTrials.gov ID
- NCT04212065
- Acronym / sponsor ID
- 2019H0354
- Conditions
- Opioid Use Disorder
- Keywords
- Sublocade, Suboxone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: closed due to new safety concerns of subcutaneous buprenorphine in pregnant patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Sublingual Suboxone | Active comparator | Drug: buprenorphineWomen randomized to sublingual dosing will be provided prescription to fill. |
| Subcutaneous Sublocade | Active comparator | Drug: buprenorphineWomen randomized to subcutaneous administration will have drug administered by nurse during routine prenatal care visits. |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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:
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| buprenorphineAlso: Sublocade, SuboxoneTo 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. | Drug | Subcutaneous Sublocade, Sublingual Suboxone |
Primary outcome
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.
3 secondary outcomes
Evaluating concentration of buprenorphine and metabolites in maternal plasma
Time frame: Enrollment through four weeks postpartum
Evaluating concentration of buprenorphine and metabolites in cord plasma
Time frame: Delivery
Evaluating concentration of buprenorphine and metabolites in breast milk
Time frame: 1-6 months postpartum
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kara Rood, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing buprenorphine in people with Opioid Use Disorder, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.