Opioid-use DisorderMOTHER DYADNCT04049799
Maternal Opioid Treatment: Human Experimental Research - Data Yield Appropriate Decisions
An observational study of Opioid-use Disorder and Opioid Withdrawal, run by University of Vermont at 4 sites in United States.
Trial summary
This study will compare medically-supervised withdrawal (MSW, 'detoxification') to opioid agonist treatment (OAT, 'maintenance') with buprenorphine for pregnant women with opioid use disorder in terms of maternal, fetal, and neonatal outcomes. Read more about this study
- Who is it for?
- Ages 18 to 41 years, women only
- Conditions the study is for
- Opioid-use Disorder, Opioid Withdrawal, Neonatal Abstinence Syndrome
- What is being tested?
- Medically-supervised withdrawal, Opioid agonist treatment and Comprehensive clinical care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 88 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Aug 2019to 1 Feb 2024
- Phase
- Observational
- 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
Study population: Pregnant women seeking treatment for opioid use disorder
Who may be able to join
- Be ages 18 to 41, inclusive
- Have a single fetus pregnancy between 6-30 weeks estimated gestational age
- Willing to participate in the study
Who cannot join
- Non-English speaking
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Mountain Area Health Education Center
Asheville, North Carolina, 28803
University of Vermont
Burlington, Vermont, 05401
UNC Chapel Hill Horizons
Chapel Hill, North Carolina, 27510
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Medically-supervised Withdrawal vs. Agonist Maintenance in the Treatment of Pregnant Women With Opioid Use Disorder: Maternal, Fetal, and Neonatal Outcomes
This study will compare medically-supervised withdrawal (MSW, 'detoxification') to opioid agonist treatment (OAT, 'maintenance') with buprenorphine for pregnant women with opioid use disorder in terms of maternal, fetal, and neonatal outcomes. Outcomes will be assessed during pregnancy, at birth and for 12 months postpartum. This study has the potential to impact health service policy and practices in terms of the treatment options of pregnant women with opioid use disorder.
Read the detailed description
Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.
- Conditions
- Opioid-use Disorder, Opioid Withdrawal, Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal Syndrome
- Being tested
- Medically-supervised withdrawal, Opioid agonist treatment, Comprehensive clinical care
- Medical subject headings
- Opioid-Related Disorders, Neonatal Abstinence Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medically-supervised withdrawalOther
Also called Detoxification
6-8 day withdrawal with buprenorphine/naloxone
Opioid agonist treatmentOther
Also called Maintenance
Induction and maintenance with buprenorphine/naloxone
Comprehensive clinical careBehavioural
Obstetrical visits, counseling, case management, psychiatry services, and urine drug screening
| Study group | Role | What they receive |
|---|---|---|
| Medically-supervised withdrawal (MSW) | Not described Receives: Other: Medically-supervised withdrawal; Behavioral: Comprehensive clinical care | |
| Opioid agonist treatment (OAT) | Not described Receives: Other: Opioid agonist treatment; Behavioral: Comprehensive clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of mothers who discontinued 1st treatment choice prior to delivery
Measured: Antepartum period
Proportion of mothers engaged in treatment at delivery
Behavior health treatment or medical treatment in past 21 days
Measured: Antepartum period
Proportion of mothers with illicit substance use at delivery
Positive vs. negative for any illicit substance in the urine
Measured: At delivery
Proportion of mother-child dyads with delivery complications
Yes vs. no code for the presence or absence of delivery complications such as uterine rupture, placental abruption, low birth weight, chorioamnionitis, and meconium staining
Measured: At delivery
Proportion of neonates receiving medication treatment for neonatal abstinence syndrome (NAS)
Yes vs. no
Measured: At hospital discharge, an average of 10 days after delivery
Total average amount of medication given to treat NAS
Morphine Equivalent Dose in mg
Measured: At hospital discharge, an average of 10 days after delivery
Total average length of neonatal hospital stay
Days
Measured: At hospital discharge, an average of 10 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start8 Aug 2019
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Virginia Commonwealth University, Mountain Area Health Education Center, Johns Hopkins University, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Sarah Heil, University of Vermont
- Investigators
- Sarah H Heil, PhD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049799
- Sponsor's protocol ID
- STUDY00000166
- Other IDs
- R01DA047867
- Acronym
- MOTHER DYAD
- Status last verified
- Feb 2024
- First submitted
- 23 Jul 2019
- Last updated
- 8 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medically-supervised Withdrawal vs. Agonist Maintenance in the Treatment of Pregnant Women With Opioid Use Disorder: Maternal, Fetal, and Neonatal Outcomes
- ClinicalTrials.gov ID
- NCT04049799
- Acronym / sponsor ID
- MOTHER DYAD / STUDY00000166
- Conditions
- Opioid-use Disorder, Opioid Withdrawal, Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Virginia Commonwealth University, Mountain Area Health Education Center, Johns Hopkins University, National Institute on Drug Abuse (NIDA)
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 8 Aug 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 study will compare medically-supervised withdrawal (MSW, 'detoxification') to opioid agonist treatment (OAT, 'maintenance') with buprenorphine for pregnant women with opioid use disorder in terms of maternal, fetal, and neonatal outcomes. Outcomes will be assessed during pregnancy, at birth and for 12 months postpartum. This study has the potential to impact health service policy and practices in terms of the treatment options of pregnant women with opioid use disorder.
Detailed description
Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medically-supervised withdrawal (MSW) | – | Other: Medically-supervised withdrawal, Behavioral: Comprehensive clinical care |
| Opioid agonist treatment (OAT) | – | Other: Opioid agonist treatment, Behavioral: Comprehensive clinical care |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women seeking treatment for opioid use disorder
Key inclusion criteria (3 listed)
- Be ages 18 to 41, inclusive
- Have a single fetus pregnancy between 6-30 weeks estimated gestational age
- Willing to participate in the study
Key exclusion criteria (1 listed)
- Non-English speaking
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 |
|---|---|---|
| Medically-supervised withdrawalAlso: Detoxification6-8 day withdrawal with buprenorphine/naloxone | Other | Medically-supervised withdrawal (MSW) |
| Opioid agonist treatmentAlso: MaintenanceInduction and maintenance with buprenorphine/naloxone | Other | Opioid agonist treatment (OAT) |
| Comprehensive clinical careObstetrical visits, counseling, case management, psychiatry services, and urine drug screening | Behavioural | Medically-supervised withdrawal (MSW), Opioid agonist treatment (OAT) |
Primary outcome
Proportion of mothers who discontinued 1st treatment choice prior to delivery
Time frame: Antepartum period
Proportion of mothers engaged in treatment at delivery
Time frame: Antepartum period
Behavior health treatment or medical treatment in past 21 days
Proportion of mothers with illicit substance use at delivery
Time frame: At delivery
Positive vs. negative for any illicit substance in the urine
Proportion of mother-child dyads with delivery complications
Time frame: At delivery
Yes vs. no code for the presence or absence of delivery complications such as uterine rupture, placental abruption, low birth weight, chorioamnionitis, and meconium staining
Proportion of neonates receiving medication treatment for neonatal abstinence syndrome (NAS)
Time frame: At hospital discharge, an average of 10 days after delivery
Yes vs. no
Total average amount of medication given to treat NAS
Time frame: At hospital discharge, an average of 10 days after delivery
Morphine Equivalent Dose in mg
Total average length of neonatal hospital stay
Time frame: At hospital discharge, an average of 10 days after delivery
Days
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 8 Feb 2024.
Related trials for Opioid-use Disorder
Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Active, not recruiting
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Peer-led, Mobile App Supported Linkage to Opioid Use Disorder Treatment
Opioid Use Disorder
Active, not recruiting
Pain and Opioids: Integrated Treatment In Veterans
Chronic Pain, Opioid-use Disorder
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.
Sarah H Heil, PhD principal investigator
University of Vermont
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-use Disorder and Opioid Withdrawal, run by University of Vermont at 4 sites 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 3 inclusion and 1 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 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
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?
Proportion of mothers who discontinued 1st treatment choice prior to delivery (time frame: Antepartum period). The study lists 7 primary outcomes in all. 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 8 Feb 2024.