Opioid Use DisorderSUPPORTNCT06576323
An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
A study testing An implementation model for co-located Medications for Opioid Use Disorder (MOUD) prescription in the NICU in people with Opioid Use Disorder and Neonatal Abstinence Syndrome, run by University of Pennsylvania at 3 sites in United States.
Trial summary
The purpose of this study is to address the gap in maternal OUD treatment and infant neonatal opioid withdrawal syndrome care. The research team will develop a treatment model and a set of strategies to provide evidence-based OUD treatment to postpartum mothers in NICUs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder, Neonatal Abstinence Syndrome
- What is being tested?
- An implementation model for co-located Medications for Opioid Use Disorder (MOUD) prescription in the NICU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jul 2024to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants should be healthcare providers working within UPHS, who generally treat perinatal women or any individuals with OUD; for the purposes of this study, provider refers to a Medical Doctor (MD) or Doctor of Osteopathy (DO), Advanced Practice Practitioner, Nurse, or Social Worker.
- Participants should provide direct care to NICU patients and/or their mothers
- Participants should be proficient in English language
- Participants should have access to a computer with internet connectivity or phone
- Participants should be biological mothers of children hospitalized in the UPHS NICU for NAS
- Participants should be diagnosed with opioid use disorder
Show all 11Show fewer
- See above for inclusion criteria for interview participants.
- We will use this same criteria to recruit new participants for Aim 3 if the same stakeholder interviewees are unavailable at the time of Aim 3.
- Participants should be biological mothers of a child hospitalized in either of the two UPHS NICU for NAS (either HUP or PAH)
- Participants should be no more than 4 weeks postpartum
- Participants should have an Opioid Use Disorder than is currently untreated with medication assisted treatment or buprenorphine
Who cannot join
- None
- None
- None
- Active suicidal ideation, or other severe psychopathology that must be addressed before effective MOUD can be prescribed
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Recruiting
Penn Center for Women's Behavioral Wellness
Philadelphia, Pennsylvania, 19104
Sara Kornfield, PhD, 215-746-1255, sarakorn@pennmedicine.upenn.edu
- Recruiting
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care
The purpose of this study is to address the gap in maternal OUD treatment and infant neonatal opioid withdrawal syndrome care. The research team will develop a treatment model and a set of strategies to provide evidence-based OUD treatment to postpartum mothers in NICUs.
First, the investigators will conduct a needs assessment via in-depth qualitative interviews with NICU mothers and clinicians. Then, with the expertise of the advisory board, the the researchers will create a protocol for implementing maternal OUD treatment at the NICU bedside. The researchers will then implement the protocol in two partner NICUs and evaluate the acceptability and feasibility to patients, providers, and clinical, and administrative leaders.
The goal of this research study is to integrate maternal mental health and substance abuse treatment in pediatric settings and to refine, test, and examine the acceptability and feasibility of applying the adapted model.
Read the detailed description
The increasing prevalence of pregnant and postpartum women affected by Opioid Use Disorder (OUD) in the US is highlighted by the growing number of babies referred to the NICU for Neonatal Abstinence Syndrome after birth. Despite recent advances in integrating mental health and substance abuse treatment into adult healthcare settings, no current treatment options exist to integrate maternal OUD treatment and referrals into the pediatric care setting making it unlikely that mothers will be able to access care. In order to preserve the dyadic bond, improve maternal functioning, and provide a more stable environment for the infant after discharge from the NICU, the researchers now embark on a study utilizing steps from intervention mapping to identify facilitators and barriers to integrated maternal OUD treatment and referral in the NICU, adapt existing evidence-based models of co-located OUD care to the NICU setting, and test the feasibility and acceptability of the new model. In Aim 1, the researchers will collect qualitative data via in-depth interviews with 32 NICU providers, social workers, administrators, and parents to determine barriers and facilitators to offering bedside buprenorphine induction and treatment. In Aim 2, the researchers will convene an advisory board to review data collected in Aim 1 and to develop a plan for implementing buprenorphine initiation into the study's unique setting to address the issue- the provision of adult focused OUD care in a pediatric care setting. Aim 2 does not constitute Human Subjects research. The primary outcome of Aim 2 will be a suite of implementation strategies to pilot test in Aim 3. Aim 3 is a pilot case series implementation trial where the researchers will test the adapted intervention to determine feasibility and acceptability to both providers and patients. As this is a case series the investigators propose to recruit 10 participants from each of the two partner NICUs for a total enrollment of N= 20 in Aim 3. A formal sample size calculation was not performed as there is no data on which to a base a formal sample size calculation. For pilot studies with an expected medium standardized effect size, a case number of N= 15 per group has been recommended for pilot studies preceding a possible main study with a power of 90%. The investigators plan to recruit 20 participants to account for possible attrition. The researchers are not necessarily powered to detect an effect. Participants will not be randomized to condition; all NICU mothers meeting inclusion criteria during the study timeline for Aim 3 will be invited to participate in Aim 3. The outcomes of acceptability and feasibility will be measured through questionnaires, interviews, and treatment initiation and retention statistics.
- Conditions
- Opioid Use Disorder, Neonatal Abstinence Syndrome
- Being tested
- An implementation model for co-located Medications for Opioid Use Disorder (MOUD) prescription in the NICU
- 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.
An implementation model for co-located Medications for Opioid Use Disorder (MOUD) prescription in the NICUBehavioural
We will use implementation mapping to develop a suite of implementation strategies to deliver evidence-based MOUD prescription to mothers attending the bedside of their infants hospitalized in the NICU. The intervention itself is buprenorphine induction and treatment, however the model for delivery is not yet developed, consistent with the need for results from Aim 1 to inform the approach used to develop the implementation model in Aim 2.
| Study group | Role | What they receive |
|---|---|---|
| Case Series | Other | In Aim 3, all recruited participants will receive the intervention. Receives: Behavioral: An implementation model for co-located Medications for Opioid Use Disorder (MOUD) prescription in the NICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Interview for NICU Providers
In-depth qualitative interview focused on providers' attitudes and knowledge about barriers and facilitators of buprenorphine induction for mothers in the NICU. This interview will be guided by the Consolidated Framework for Implementation Research to query about barriers and facilitators of MOUD provision in the NICU, with the primary goal of identifying contextual determinants of co-located care.
Measured: Time 1 (baseline)
Qualitative Interview for Parents
In-dept qualitative interview focused on mothers' attitudes about receiving MOUD in the NICU while caring for their hospitalized infant. This interview will be guided by the Consolidated Framework for Implementation Research to query about what would make this more attractive, feasible, and engagement more likely.
Measured: Time 1 (baseline)
Feasibility of Intervention Measure
A 4-item,psychometrically-validated measure that indexes the extent to which stakeholders perceive an implementation strategy is feasible.
Measured: Up to 9 months
Acceptability of Intervention Measure
A 4-item,psychometrically-validated measure that indexes the extent to which stakeholders perceive an implementation strategy is acceptable.
Measured: Up to 9 months
Recruitment and Retention Statistics
The proportion of mothers of babies in the NICU who agree to receive MOUD in the NICU (Time 2; T2), who remain in care for the duration of their baby's stay (Time 3; T3), and length of time they remain in outpatient treatment after treatment (Time 4; T4).
Measured: Up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start1 Jul 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (56)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Kornfield, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576323
- Sponsor's protocol ID
- R21DA058815
- Acronym
- SUPPORT
- Status last verified
- Jul 2026
- First submitted
- 6 Aug 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hirai AH, Ko JY, Owens PL, Stocks C, Patrick SW. Neonatal Abstinence Syndrome and Maternal Opioid-Related Diagnoses in the US, 2010-2017. JAMA. 2021 Jan 12;325(2):146-155. doi: 10.1001/jama.2020.24991.
PubMed 33433576Winkelman TNA, Villapiano N, Kozhimannil KB, Davis MM, Patrick SW. Incidence and Costs of Neonatal Abstinence Syndrome Among Infants With Medicaid: 2004-2014. Pediatrics. 2018 Apr;141(4):e20173520. doi: 10.1542/peds.2017-3520.
PubMed 29572288Ray-Griffith S, Tharp E, Coker JL, Catlin D, Knight B, Stowe ZN. Buprenorphine Medication for Opioid Use Disorder: A Study of Factors Associated With Postpartum Treatment Retention. Am J Addict. 2021 Jan;30(1):43-48. doi: 10.1111/ajad.13084. Epub 2020 Jul 16.
PubMed 32673447Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
PubMed 19664226Becker-Haimes EM, Mandell DS, Fishman J, Williams NJ, Wolk CB, Wislocki K, Reich D, Schaechter T, Brady M, Maples NJ, Creed TA. Assessing Causal Pathways and Targets of Implementation Variability for EBP use (Project ACTIVE): a study protocol. Implement Sci Commun. 2021 Dec 20;2(1):144. doi: 10.1186/s43058-021-00245-3.
PubMed 34930483Fernandez ME, Ten Hoor GA, van Lieshout S, Rodriguez SA, Beidas RS, Parcel G, Ruiter RAC, Markham CM, Kok G. Implementation Mapping: Using Intervention Mapping to Develop Implementation Strategies. Front Public Health. 2019 Jun 18;7:158. doi: 10.3389/fpubh.2019.00158. eCollection 2019.
PubMed 31275915Committee Opinion No. 711: Opioid Use and Opioid Use Disorder in Pregnancy. Obstet Gynecol. 2017 Aug;130(2):e81-e94. doi: 10.1097/AOG.0000000000002235.
PubMed 28742676Ko JY, Patrick SW, Tong VT, Patel R, Lind JN, Barfield WD. Incidence of Neonatal Abstinence Syndrome - 28 States, 1999-2013. MMWR Morb Mortal Wkly Rep. 2016 Aug 12;65(31):799-802. doi: 10.15585/mmwr.mm6531a2.
PubMed 27513154McQueen K, Murphy-Oikonen J. Neonatal Abstinence Syndrome. N Engl J Med. 2016 Dec 22;375(25):2468-2479. doi: 10.1056/NEJMra1600879. No abstract available.
PubMed 28002715Patrick SW, Schumacher RE, Benneyworth BD, Krans EE, McAllister JM, Davis MM. Neonatal abstinence syndrome and associated health care expenditures: United States, 2000-2009. JAMA. 2012 May 9;307(18):1934-40. doi: 10.1001/jama.2012.3951. Epub 2012 Apr 30.
PubMed 22546608Tolia VN, Patrick SW, Bennett MM, Murthy K, Sousa J, Smith PB, Clark RH, Spitzer AR. Increasing incidence of the neonatal abstinence syndrome in U.S. neonatal ICUs. N Engl J Med. 2015 May 28;372(22):2118-26. doi: 10.1056/NEJMsa1500439. Epub 2015 Apr 26.
PubMed 25913111Substance Abuse and Mental Health Services Administration (US); Office of the Surgeon General (US). Facing Addiction in America: The Surgeon General's Spotlight on Opioids [Internet]. Washington (DC): US Department of Health and Human Services; 2018 Sep. Available from http://www.ncbi.nlm.nih.gov/books/NBK538436/
PubMed 30860690Ko JY, Tong VT, Haight SC, Terplan M, Snead C, Schulkin J. Obstetrician-gynecologists' practice patterns related to opioid use during pregnancy and postpartum-United States, 2017. J Perinatol. 2020 Mar;40(3):412-421. doi: 10.1038/s41372-019-0535-2. Epub 2019 Oct 15.
PubMed 31616051Seehusen DA, Baldwin LM, Runkle GP, Clark G. Are family physicians appropriately screening for postpartum depression? J Am Board Fam Pract. 2005 Mar-Apr;18(2):104-12. doi: 10.3122/jabfm.18.2.104.
PubMed 15798139Olin SS, McCord M, Stein REK, Kerker BD, Weiss D, Hoagwood KE, Horwitz SM. Beyond Screening: A Stepped Care Pathway for Managing Postpartum Depression in Pediatric Settings. J Womens Health (Larchmt). 2017 Sep;26(9):966-975. doi: 10.1089/jwh.2016.6089. Epub 2017 Apr 14.
PubMed 28409703
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care
- ClinicalTrials.gov ID
- NCT06576323
- Acronym / sponsor ID
- SUPPORT / R21DA058815
- Conditions
- Opioid Use Disorder, Neonatal Abstinence Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 28 Aug 2024 (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.
The purpose of this study is to address the gap in maternal OUD treatment and infant neonatal opioid withdrawal syndrome care. The research team will develop a treatment model and a set of strategies to provide evidence-based OUD treatment to postpartum mothers in NICUs.
First, the investigators will conduct a needs assessment via in-depth qualitative interviews with NICU mothers and clinicians. Then, with the expertise of the advisory board, the the researchers will create a protocol for implementing maternal OUD treatment at the NICU bedside. The researchers will then implement the protocol in two partner NICUs and evaluate the acceptability and feasibility to patients, providers, and clinical, and administrative leaders.
The goal of this research study is to integrate maternal mental health and substance abuse treatment in pediatric settings and to refine, test, and examine the acceptability and feasibility of applying the adapted model.
Detailed description
The increasing prevalence of pregnant and postpartum women affected by Opioid Use Disorder (OUD) in the US is highlighted by the growing number of babies referred to the NICU for Neonatal Abstinence Syndrome after birth. Despite recent advances in integrating mental health and substance abuse treatment into adult healthcare settings, no current treatment options exist to integrate maternal OUD treatment and referrals into the pediatric care setting making it unlikely that mothers will be able to access care. In order to preserve the dyadic bond, improve maternal functioning, and provide a more stable environment for the infant after discharge from the NICU, the researchers now embark on a study utilizing steps from intervention mapping to identify facilitators and barriers to integrated maternal OUD treatment and referral in the NICU, adapt existing evidence-based models of co-located OUD care to the NICU setting, and test the feasibility and acceptability of the new model. In Aim 1, the researchers will collect qualitative data via in-depth interviews with 32 NICU providers, social workers, administrators, and parents to determine barriers and facilitators to offering bedside buprenorphine induction and treatment. In Aim 2, the researchers will convene an advisory board to review data collected in Aim 1 and to develop a plan for implementing buprenorphine initiation into the study's unique setting to address the issue- the provision of adult focused OUD care in a pediatric care setting. Aim 2 does not constitute Human Subjects research. The primary outcome of Aim 2 will be a suite of implementation strategies to pilot test in Aim 3. Aim 3 is a pilot case series implementation trial where the researchers will test the adapted intervention to determine feasibility and acceptability to both providers and patients. As this is a case series the investigators propose to recruit 10 participants from each of the two partner NICUs for a total enrollment of N= 20 in Aim 3. A formal sample size calculation was not performed as there is no data on which to a base a formal sample size calculation. For pilot studies with an expected medium standardized effect size, a case number of N= 15 per group has been recommended for pilot studies preceding a possible main study with a power of 90%. The investigators plan to recruit 20 participants to account for possible attrition. The researchers are not necessarily powered to detect an effect. Participants will not be randomized to condition; all NICU mothers meeting inclusion criteria during the study timeline for Aim 3 will be invited to participate in Aim 3. The outcomes of acceptability and feasibility will be measured through questionnaires, interviews, and treatment initiation and retention statistics.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case Series | Other | Behavioral: An implementation model for co-located Medications for Opioid Use Disorder (MOUD) prescription in the NICUIn Aim 3, all recruited participants will receive the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants should be healthcare providers working within UPHS, who generally treat perinatal women or any individuals with OUD; for the purposes of this study, provider refers to a Medical Doctor (MD) or Doctor of Osteopathy (DO), Advanced Practice Practitioner, Nurse, or Social Worker.
- Participants should provide direct care to NICU patients and/or their mothers
- Participants should be proficient in English language
- Participants should have access to a computer with internet connectivity or phone
- Participants should be biological mothers of children hospitalized in the UPHS NICU for NAS
Key exclusion criteria (4 listed)
- None
- None
- None
- Active suicidal ideation, or other severe psychopathology that must be addressed before effective MOUD can be prescribed
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 |
|---|---|---|
| An implementation model for co-located Medications for Opioid Use Disorder (MOUD) prescription in the NICUWe will use implementation mapping to develop a suite of implementation strategies to deliver evidence-based MOUD prescription to mothers attending the bedside of their infants hospitalized in the NICU. The intervention itself is buprenorphine induction and treatment, however the model for delivery is not yet developed, consistent with the need for results from Aim 1 to inform the approach used to develop the implementation model in Aim 2. | Behavioural | Case Series |
Primary outcome
Qualitative Interview for NICU Providers
Time frame: Time 1 (baseline)
In-depth qualitative interview focused on providers' attitudes and knowledge about barriers and facilitators of buprenorphine induction for mothers in the NICU. This interview will be guided by the Consolidated Framework for Implementation Research to query about barriers and facilitators of MOUD provision in the NICU, with the primary goal of identifying contextual determinants of co-located care.
Qualitative Interview for Parents
Time frame: Time 1 (baseline)
In-dept qualitative interview focused on mothers' attitudes about receiving MOUD in the NICU while caring for their hospitalized infant. This interview will be guided by the Consolidated Framework for Implementation Research to query about what would make this more attractive, feasible, and engagement more likely.
Feasibility of Intervention Measure
Time frame: Up to 9 months
A 4-item,psychometrically-validated measure that indexes the extent to which stakeholders perceive an implementation strategy is feasible.
Acceptability of Intervention Measure
Time frame: Up to 9 months
A 4-item,psychometrically-validated measure that indexes the extent to which stakeholders perceive an implementation strategy is acceptable.
Recruitment and Retention Statistics
Time frame: Up to 1 year.
The proportion of mothers of babies in the NICU who agree to receive MOUD in the NICU (Time 2; T2), who remain in care for the duration of their baby's stay (Time 3; T3), and length of time they remain in outpatient treatment after treatment (Time 4; T4).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Background: PubMed 33433576Hirai AH, Ko JY, Owens PL, Stocks C, Patrick SW. Neonatal Abstinence Syndrome and Maternal Opioid-Related Diagnoses in the US, 2010-2017. JAMA. 2021 Jan 12;325(2):146-155. doi: 10.1001/jama.2020.24991.
- Background: PubMed 29572288Winkelman TNA, Villapiano N, Kozhimannil KB, Davis MM, Patrick SW. Incidence and Costs of Neonatal Abstinence Syndrome Among Infants With Medicaid: 2004-2014. Pediatrics. 2018 Apr;141(4):e20173520. doi: 10.1542/peds.2017-3520.
- Background: PubMed 32673447Ray-Griffith S, Tharp E, Coker JL, Catlin D, Knight B, Stowe ZN. Buprenorphine Medication for Opioid Use Disorder: A Study of Factors Associated With Postpartum Treatment Retention. Am J Addict. 2021 Jan;30(1):43-48. doi: 10.1111/ajad.13084. Epub 2020 Jul 16.
- Background: PubMed 19664226Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
- Background: PubMed 34930483Becker-Haimes EM, Mandell DS, Fishman J, Williams NJ, Wolk CB, Wislocki K, Reich D, Schaechter T, Brady M, Maples NJ, Creed TA. Assessing Causal Pathways and Targets of Implementation Variability for EBP use (Project ACTIVE): a study protocol. Implement Sci Commun. 2021 Dec 20;2(1):144. doi: 10.1186/s43058-021-00245-3.
- Background: PubMed 31275915Fernandez ME, Ten Hoor GA, van Lieshout S, Rodriguez SA, Beidas RS, Parcel G, Ruiter RAC, Markham CM, Kok G. Implementation Mapping: Using Intervention Mapping to Develop Implementation Strategies. Front Public Health. 2019 Jun 18;7:158. doi: 10.3389/fpubh.2019.00158. eCollection 2019.
- Background: PubMed 28742676Committee Opinion No. 711: Opioid Use and Opioid Use Disorder in Pregnancy. Obstet Gynecol. 2017 Aug;130(2):e81-e94. doi: 10.1097/AOG.0000000000002235.
- Background: PubMed 27513154Ko JY, Patrick SW, Tong VT, Patel R, Lind JN, Barfield WD. Incidence of Neonatal Abstinence Syndrome - 28 States, 1999-2013. MMWR Morb Mortal Wkly Rep. 2016 Aug 12;65(31):799-802. doi: 10.15585/mmwr.mm6531a2.
- Background: PubMed 28002715McQueen K, Murphy-Oikonen J. Neonatal Abstinence Syndrome. N Engl J Med. 2016 Dec 22;375(25):2468-2479. doi: 10.1056/NEJMra1600879. No abstract available.
- Background: PubMed 22546608Patrick SW, Schumacher RE, Benneyworth BD, Krans EE, McAllister JM, Davis MM. Neonatal abstinence syndrome and associated health care expenditures: United States, 2000-2009. JAMA. 2012 May 9;307(18):1934-40. doi: 10.1001/jama.2012.3951. Epub 2012 Apr 30.
- Background: PubMed 25913111Tolia VN, Patrick SW, Bennett MM, Murthy K, Sousa J, Smith PB, Clark RH, Spitzer AR. Increasing incidence of the neonatal abstinence syndrome in U.S. neonatal ICUs. N Engl J Med. 2015 May 28;372(22):2118-26. doi: 10.1056/NEJMsa1500439. Epub 2015 Apr 26.
- Background: PubMed 30860690Substance Abuse and Mental Health Services Administration (US); Office of the Surgeon General (US). Facing Addiction in America: The Surgeon General's Spotlight on Opioids [Internet]. Washington (DC): US Department of Health and Human Services; 2018 Sep. Available from http://www.ncbi.nlm.nih.gov/books/NBK538436/
- 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.
Sara Kornfield, PhD principal investigator
University of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An implementation model for co-located Medications for Opioid Use Disorder (MOUD) prescription in the NICU in people with Opioid Use Disorder and Neonatal Abstinence Syndrome, run by University of Pennsylvania at 3 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 11 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Kornfield, PhD (215-746-1255, sarakorn@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative Interview for NICU Providers (time frame: Time 1 (baseline)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06576323, which also lists 56 linked publications.
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 6 Jul 2026.