Neonatal Abstinence SyndromePhase 1MOPPlusNCT01671410
Buprenorphine for Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines
A Phase 1 study testing oral morphine and sublingual buprenorphine in people with Neonatal Abstinence Syndrome, run by Thomas Jefferson University at 1 site in United States.
Trial summary
The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. Sublingual buprenorphine shows promise as a new treatment in NAS. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neonatal Abstinence Syndrome
- What is being tested?
- oral morphine and sublingual buprenorphine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Sep 2016
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ≥ 37 weeks gestation
- Exposure to opioids in utero
- Demonstration of signs and symptoms of neonatal abstinence syndrome requiring treatment
- Exposure to benzodiazepines in utero and/or receiving breast milk. Benzodiazepine use is defined as maternal use in the past 30 days, and/or receipt of benzodiazepines by prescription (as determined by self-report or intake urine) by the mother 30 days prior to birth.
Who cannot join
- Major congenital malformations and/or intrauterine growth retardation defined as birth weight <2200 gm
- Medical illness requiring intensification of medical therapy. This includes, but is not limited to suspected sepsis requiring antibiotic therapy.
- Hypoglycemia requiring treatment with intravenous dextrose
- Bilirubin >20 mg/dL (The need for phototherapy is not exclusionary)
- Seizure activity or other neurologic abnormality
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Randomized, Open Label Clinical Trial of Buprenorphine in the Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines or Are Breastfeeding
The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. Sublingual buprenorphine shows promise as a new treatment in NAS. This trial will investigate the safety and tolerability of sublingual buprenorphine in infants exposed to both opioids and benzodiazepines in utero or with exposure of opioids in those who are breastfeeding.
Read the detailed description
Infants with in utero exposure to opioids often require therapy with morphine for an extended period. In a clinical trial, sublingual buprenorphine reduced this treatment period by ~30%. However, infants with both opioid and benzodiazepine exposure were not included in the trial. This study will test the safety and tolerability of sublingual buprenorphine in infants with in utero exposure to benzodiazepines or who are breastfeeding.
- Conditions
- Neonatal Abstinence Syndrome
- Being tested
- oral morphine, sublingual buprenorphine
- Keywords
- Neonatal Abstinence Syndrome, buprenorphine, morphine, benzodiazepine
- Medical subject headings
- Neonatal Abstinence Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral morphineDrug
Also called morphine
Oral morphine for the treatment of neonatal abstinence syndrome
sublingual buprenorphineDrug
Also called buprenex
Sublingual buprenorphine for the treatment of neonatal abstinence syndrome
| Study group | Role | What they receive |
|---|---|---|
| sublingual buprenorphine | Experimental | Initial daily dose: 15.9 mcg/kg/day; Initial unit dose: 5.3 mcg/kg q8 hours; Maximum daily dose: 60 mcg/kg/day; Up-titration rate: 25%; Weaning rate: 10%; Cessation Dose: Within 10 or 20% of starting dose Receives: Drug: sublingual buprenorphine |
| oral morphine | Active comparator | Initial daily dose: 0.4 mg/kg/day; Initial unit dose: 0.07 mg/kg q 4 hours; Maximum daily dose: 1.25 mg/kg/day; Up-titration rate: 20%; Weaning rate: 10%; Cessation Dose: 0.025 mg/kg q 4 hours Receives: Drug: oral morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of treatment
This endpoint will compare length of treatment (in days) using sublingual buprenorphine or oral morphine solution.
Measured: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks
Secondary outcomes (3)
Length of hospitalization
This endpoint will compare length of stay (in days) using sublingual buprenorphine or oral morphine
Measured: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks
Number of patients requiring supplemental phenobarbital treatment
This endpoint will compare requirement number of patients who require use of supplemental phenobarbital for treatment of NAS
Measured: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks
Number of participants with adverse events as a measure of safety and tolerability
Adverse events will be collected, graded by severity, and assessed for causality referent to study drug.
Measured: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Abstinence SyndromeStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Walter K Kraft, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671410
- Sponsor's protocol ID
- 12D.398
- Acronym
- MOPPlus
- Status last verified
- Oct 2016
- First submitted
- 20 Aug 2012
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label Clinical Trial of Buprenorphine in the Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines or Are Breastfeeding
- ClinicalTrials.gov ID
- NCT01671410
- Acronym / sponsor ID
- MOPPlus / 12D.398
- Conditions
- Neonatal Abstinence Syndrome
- Keywords
- Neonatal Abstinence Syndrome, buprenorphine, morphine, benzodiazepine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 23 Aug 2012 (estimated)
- 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.
The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. Sublingual buprenorphine shows promise as a new treatment in NAS. This trial will investigate the safety and tolerability of sublingual buprenorphine in infants exposed to both opioids and benzodiazepines in utero or with exposure of opioids in those who are breastfeeding.
Detailed description
Infants with in utero exposure to opioids often require therapy with morphine for an extended period. In a clinical trial, sublingual buprenorphine reduced this treatment period by ~30%. However, infants with both opioid and benzodiazepine exposure were not included in the trial. This study will test the safety and tolerability of sublingual buprenorphine in infants with in utero exposure to benzodiazepines or who are breastfeeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sublingual buprenorphine | Experimental | Drug: sublingual buprenorphineInitial daily dose: 15.9 mcg/kg/day; Initial unit dose: 5.3 mcg/kg q8 hours; Maximum daily dose: 60 mcg/kg/day; Up-titration rate: 25%; Weaning rate: 10%; Cessation Dose: Within 10 or 20% of starting dose |
| oral morphine | Active comparator | Drug: oral morphineInitial daily dose: 0.4 mg/kg/day; Initial unit dose: 0.07 mg/kg q 4 hours; Maximum daily dose: 1.25 mg/kg/day; Up-titration rate: 20%; Weaning rate: 10%; Cessation Dose: 0.025 mg/kg q 4 hours |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 37 weeks gestation
- Exposure to opioids in utero
- Demonstration of signs and symptoms of neonatal abstinence syndrome requiring treatment
- Exposure to benzodiazepines in utero and/or receiving breast milk. Benzodiazepine use is defined as maternal use in the past 30 days, and/or receipt of benzodiazepines by prescription (as determined by self-report or intake urine) by the mother 30 days prior to birth.
Key exclusion criteria (5 listed)
- Major congenital malformations and/or intrauterine growth retardation defined as birth weight <2200 gm
- Medical illness requiring intensification of medical therapy. This includes, but is not limited to suspected sepsis requiring antibiotic therapy.
- Hypoglycemia requiring treatment with intravenous dextrose
- Bilirubin >20 mg/dL (The need for phototherapy is not exclusionary)
- Seizure activity or other neurologic abnormality
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 |
|---|---|---|
| oral morphineAlso: morphineOral morphine for the treatment of neonatal abstinence syndrome | Drug | oral morphine |
| sublingual buprenorphineAlso: buprenexSublingual buprenorphine for the treatment of neonatal abstinence syndrome | Drug | sublingual buprenorphine |
Primary outcome
Length of treatment
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks
This endpoint will compare length of treatment (in days) using sublingual buprenorphine or oral morphine solution.
3 secondary outcomes
Length of hospitalization
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks
Number of patients requiring supplemental phenobarbital treatment
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
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An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
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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.
Walter K Kraft, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing oral morphine and sublingual buprenorphine in people with Neonatal Abstinence Syndrome, run by Thomas Jefferson 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 14 Oct 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Length of treatment (time frame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks). 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 2016.