PregnancyPhase 2SUPPORT MOMNCT07776457
Substance Use in Pregnancy - Optimizing Retention in Treatment by Maximizing Opportunities for Management
A Phase 2 study testing Contingency Management and Social Drivers of Health Screening in people with Pregnancy and Substance Use Disorder (SUD), run by Washington University School of Medicine at 1 site in United States.
Trial summary
Overdose is a national top-three leading cause of pregnancy-associated death, and maternal substance use disorder (SUD) accounts for an estimated $1.5 billion in healthcare spending each year. Treatment with medication and behavioral therapy lowers morbidity and overdose risk. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Substance Use Disorder (SUD)
- What is being tested?
- Contingency Management and Social Drivers of Health Screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Feb 2030
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed viable intrauterine pregnancy at any gestational age; OR postpartum with at least six months remaining until 365 days after deliver
- Diagnosis of SUD as defined by DSM-5 and/or as documented in the clinical record
- 18 years of age or older
- Two or more positive domains in first screening for social drivers of health
- Receiving ongoing care at participating study site
Who cannot join
- Declining follow-up care at participating study site
- Participated in R61 pilot study for CM
- Requiring immediate hospitalization for unstable medical or psychiatric conditions making patient clinically unsuitable for research participation at the time of enrollment approach
- Unable to participate in English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Washington University
St Louis, Missouri, 63110
Melissa Mills, BS, (557) 234-9066, melissa.mills@wustl.edu
Jeannie C Kelly, MD, MS
About this study
Official title: Substance Use in Pregnancy- Optimizing Retention in Treatment by Maximizing Opportunities for Management
Overdose is a national top-three leading cause of pregnancy-associated death, and maternal substance use disorder (SUD) accounts for an estimated $1.5 billion in healthcare spending each year. Treatment with medication and behavioral therapy lowers morbidity and overdose risk. However, studies have shown 55% to 80% of patients stop treatment within one year postpartum. Additionally, as a result of systemic inequities, historically marginalized patients are at greatest risk of overdose or death. We are conducting a study at WashU Medicine and University of Maryland, Baltimore clinics that offer prenatal care, addiction treatment, and extended postpartum support for patients facing the challenges of a SUD. Study participants will complete a structured screening and management of their social needs, and then will be randomly assigned to continue their usual care or to participate in a contingency management program, which provides incentives to continue treatment.
- Conditions
- Pregnancy, Substance Use Disorder (SUD)
- Being tested
- Contingency Management, Social Drivers of Health Screening
- Keywords
- randomized, pregnancy, prenatal, substance use disorder, contingency management, postpartum, intervention
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency ManagementBehavioural
12 weekly sessions, 15-20 minutes each
Social Drivers of Health ScreeningOther
Screening for social drivers of health, documentation of applicable z-codes in the medical record and social needs linkage
| Study group | Role | What they receive |
|---|---|---|
| Contingency Management | Experimental | Receiving social drivers screening, all standard clinical care, and contingency management Receives: Behavioral: Contingency Management; Other: Social Drivers of Health Screening |
| Usual Care | Active comparator | Receiving social drivers screening and all standard clinical care Receives: Other: Social Drivers of Health Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with no unplanned 60-day gap in clinical care
Measured: Randomization through 1 year postpartum or end of study, whichever comes first, up to 92 weeks
Median number of days until time to loss to follow-up
Median number of days until loss to follow-up defined as unplanned 60-day gap in clinical care
Measured: From date of randomization until 1 year postpartum or end of study, whichever comes first, up to 92 weeks
Number of Urine Drug Screen (UDS) positive for prescribed Medication for Opioid Use Disorder (MOUD)
Measured: Randomization through 1 year postpartum or end of study, whichever comes first, up to 92 weeks
Secondary outcomes (10)
Number of urine drug screen (UDS) negative for non prescribed substances
Measured: Randomization through 1 year postpartum or study end, whichever comes first, up to 92 weeks
Number of patients randomized pregnant that have preterm birth
Preterm birth defined as live birth <37 weeks, 0 days gestational duration
Measured: After randomization, at delivery
Number of liveborn opioid exposed infants receiving pharmacologic treatment for Neonatal Opioid Withdrawal Syndrome
Pharmacologic treatment for Neonatal Opioid Withdrawal Syndrome (NOWS), among opioid exposed infants delivered by patients pregnant at randomization
Measured: After randomization and delivery, during delivery admission, up to 1 month after delivery
Number of infants admitted to NICU
Infant admitted to the neonatal intensive care unit for any length of time after delivery during delivery admission, among patients pregnant at randomization
Measured: After randomization and delivery, during delivery admission
Median number of days of NICU Length of Stay
Length of hospital admission in the NICU in days, among infants admitted to NICU
Measured: After randomization and delivery, during delivery admission, until delivery admission discharge, an average of two weeks
Median number of maternal hospital admissinons to inpatient service
Number of hospital admissions to inpatient service (excluding delivery admission, ED and triage visits)
Measured: Randomization through 1 year postpartum or study end, whichever comes first, up to 92 weeks
Number of participants with overdose
Documented overdose in medical record or by patient self-report
Measured: Randomization through 1 year postpartum or study end, whichever comes first, up to 92 weeks
Number of maternal deaths
Measured: Randomization through 1 year postpartum or study end, whichever comes first, up to 92 weeks
Number of participants with custody of infant at hospital discharge
Custody of infant at hospital discharge , among patients pregnant at randomization
Measured: At infant discharge from delivery admission, an average of two weeks
Count of participants reporting each child custody scenario
Options: full custody of all children, full custody of some children, full custody of no children, N/A
Measured: 6 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study startJan 2027 (estimated)
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 245 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, Baltimore
- Responsible party
- Sponsor
- Investigators
- Jeannie C Kelly, MD, MS, Principal investigator, Washington University School of MedicineAna A Baumann, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776457
- Sponsor's protocol ID
- 202608051
- Acronym
- SUPPORT MOM
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual patient data will be shared. We do not plan to restrict access to any data.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance Use in Pregnancy- Optimizing Retention in Treatment by Maximizing Opportunities for Management
- ClinicalTrials.gov ID
- NCT07776457
- Acronym / sponsor ID
- SUPPORT MOM / 202608051
- Conditions
- Pregnancy, Substance Use Disorder (SUD)
- Keywords
- randomized, pregnancy, prenatal, substance use disorder, contingency management, postpartum, intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 245 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Maryland, Baltimore
- Study start
- Jan 2027 (estimated)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 20 Aug 2026 (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.
Overdose is a national top-three leading cause of pregnancy-associated death, and maternal substance use disorder (SUD) accounts for an estimated $1.5 billion in healthcare spending each year. Treatment with medication and behavioral therapy lowers morbidity and overdose risk. However, studies have shown 55% to 80% of patients stop treatment within one year postpartum. Additionally, as a result of systemic inequities, historically marginalized patients are at greatest risk of overdose or death. We are conducting a study at WashU Medicine and University of Maryland, Baltimore clinics that offer prenatal care, addiction treatment, and extended postpartum support for patients facing the challenges of a SUD. Study participants will complete a structured screening and management of their social needs, and then will be randomly assigned to continue their usual care or to participate in a contingency management program, which provides incentives to continue treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contingency Management | Experimental | Behavioral: Contingency Management, Other: Social Drivers of Health ScreeningReceiving social drivers screening, all standard clinical care, and contingency management |
| Usual Care | Active comparator | Other: Social Drivers of Health ScreeningReceiving social drivers screening and all standard clinical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed viable intrauterine pregnancy at any gestational age; OR postpartum with at least six months remaining until 365 days after deliver
- Diagnosis of SUD as defined by DSM-5 and/or as documented in the clinical record
- 18 years of age or older
- Two or more positive domains in first screening for social drivers of health
- Receiving ongoing care at participating study site
Key exclusion criteria (4 listed)
- Declining follow-up care at participating study site
- Participated in R61 pilot study for CM
- Requiring immediate hospitalization for unstable medical or psychiatric conditions making patient clinically unsuitable for research participation at the time of enrollment approach
- Unable to participate in English
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 |
|---|---|---|
| Contingency Management12 weekly sessions, 15-20 minutes each | Behavioural | Contingency Management |
| Social Drivers of Health ScreeningScreening for social drivers of health, documentation of applicable z-codes in the medical record and social needs linkage | Other | Contingency Management, Usual Care |
Primary outcome
Number of participants with no unplanned 60-day gap in clinical care
Time frame: Randomization through 1 year postpartum or end of study, whichever comes first, up to 92 weeks
Median number of days until time to loss to follow-up
Time frame: From date of randomization until 1 year postpartum or end of study, whichever comes first, up to 92 weeks
Median number of days until loss to follow-up defined as unplanned 60-day gap in clinical care
Number of Urine Drug Screen (UDS) positive for prescribed Medication for Opioid Use Disorder (MOUD)
Time frame: Randomization through 1 year postpartum or end of study, whichever comes first, up to 92 weeks
10 secondary outcomes
Number of urine drug screen (UDS) negative for non prescribed substances
Time frame: Randomization through 1 year postpartum or study end, whichever comes first, up to 92 weeks
Number of patients randomized pregnant that have preterm birth
Time frame: After randomization, at delivery
Number of liveborn opioid exposed infants receiving pharmacologic treatment for Neonatal Opioid Withdrawal Syndrome
Time frame: After randomization and delivery, during delivery admission, up to 1 month after delivery
Number of infants admitted to NICU
Time frame: After randomization and delivery, during delivery admission
Median number of days of NICU Length of Stay
Time frame: After randomization and delivery, during delivery admission, until delivery admission discharge, an average of two weeks
Median number of maternal hospital admissinons to inpatient service
Time frame: Randomization through 1 year postpartum or study end, whichever comes first, up to 92 weeks
Number of participants with overdose
Time frame: Randomization through 1 year postpartum or study end, whichever comes first, up to 92 weeks
Number of maternal deaths
Time frame: Randomization through 1 year postpartum or study end, whichever comes first, up to 92 weeks
Number of participants with custody of infant at hospital discharge
Time frame: At infant discharge from delivery admission, an average of two weeks
Count of participants reporting each child custody scenario
Time frame: 6 months post randomization
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 20 Aug 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual patient data will be shared. We do not plan to restrict access to any data.
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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.
Jeannie C Kelly, MD, MS principal investigator
Washington University School of Medicine
Ana A Baumann, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Contingency Management and Social Drivers of Health Screening in people with Pregnancy and Substance Use Disorder (SUD), run by Washington University School of Medicine 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 5 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: opening soon, as of the sponsor's last update on 20 Aug 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Melissa Mills ((557) 234-9066, melissa.mills@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with no unplanned 60-day gap in clinical care (time frame: Randomization through 1 year postpartum or end of study, whichever comes first, up to 92 weeks). The study lists 3 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 20 Aug 2026.