Opioid-Related DisordersMOMs-CMANCT03911466
Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study
An observational study of Opioid-Related Disorders and Drug Addiction, run by T. John Winhusen, PhD at 12 sites in United States.
Trial summary
This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Participants in MOMs will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanisms by which… Read more about this study
- Who is it for?
- Ages 18 to 41 years, women only
- Conditions the study is for
- Opioid-Related Disorders, Drug Addiction, Pregnancy Related
- What is being tested?
- Buprenorphine Injection and Buprenorphine Sublingual Product
- Type of treatment
- Injection or infusion
- How many people
- 97 participants
- Where
- 12 sitesUnited States
- Study dates
- 21 Jul 2020to 6 Nov 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: Participants in this study were recruited from the main CTN-0080 MOMs (NCT03918850) study sample.
Who may be able to join
- Participating in the MOMs trial (Unique protocol ID: 2019-0429-1)
Who cannot join
- -
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of New Mexico Milagro Clinic
Albuquerque, New Mexico, 87106
Massachusetts General Hospital HOPE Clinic
Boston, Massachusetts, 02114
Boston Medical Center
Boston, Massachusetts, 02118
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Cincinnati Health Perinatal Addictions Program
Cincinnati, Ohio, 45229
Marshall Health MARC Program
Huntington, West Virginia, 25701
Gateway Community Services
Jacksonville, Florida, 32204
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Pregnancy Recovery Center at Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
CODA, Inc.
Portland, Oregon, 97214
University of Utah SUPeRAD Clinic
Salt Lake City, Utah, 84108
Addiction Recovery Services (ARS), Swedish Medical Center
Seattle, Washington, 98107
About this study
Official title: NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): a Pragmatic Randomized Trial Comparing Extended-release and Daily Buprenorphine Formulations: Conceptual Model Assessments (CMA) Sub-study
This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Participants in MOMs will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanisms by which extended-release buprenorphine (BUP-XR), may improve mother-infant outcomes, compared to sublingual buprenorphine (BUP-SL). The additional data collected in this sub-study will be combined with data from the main MOMs trial.
It is hypothesized that: (1) the buprenorphine blood levels will vary, depending on which formulation of buprenorphine was received, (2) the variation in buprenorphine blood levels will be associated with fetal behavior (including fetal heart rate variability) (3) the variation in buprenorphine blood levels will be associated with differences in mother outcomes (including medication adherence and illicit opioid use) (4) the variation in buprenorphine blood levels and in fetal behavior will be associated with infant outcomes (including neonatal opioid withdrawal syndrome and infant development).
- Conditions
- Opioid-Related Disorders, Drug Addiction, Pregnancy Related, Substance Abuse, Drug Abuse, Neonatal Abstinence Syndrome
- Being tested
- Buprenorphine Injection, Buprenorphine Sublingual Product
- Keywords
- CTN-0080, clinical trials network, medication assisted treatment, pharmacokinetics
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders, Neonatal Abstinence Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine InjectionDrug
Also called CAM2038
Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
Buprenorphine Sublingual ProductDrug
Also called Subutex, Suboxone
Sublingual buprenorphine (BUP-SL), administered daily.
| Study group | Role | What they receive |
|---|---|---|
| BUP-XR | Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Receives: Drug: Buprenorphine Injection | |
| BUP-SL | Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). Receives: Drug: Buprenorphine Sublingual Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmin of buprenorphine and metabolites in plasma
A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model.
Measured: 2 weeks post-randomization
Cmin of buprenorphine and metabolites in plasma
A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model.
Measured: 4 weeks post-randomization
Fetal heart rate variability
This is the measure of primary interest from the fetal evaluation (non-stress test and biophysical profile).
Measured: Estimated gestational age (EGA) approximately 36 weeks
Cmin of buprenorphine and metabolites in plasma
A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate trough-to-peak fluctuation for the conceptual model.
Measured: Estimated gestational age (EGA) approximately 36 weeks
Cmax of buprenorphine and metabolites in plasma
A blood draw at the estimated time of maximum drug concentration ("peak") to evaluate trough-to-peak fluctuation for the conceptual model.
Measured: Estimated gestational age (EGA) approximately 36 weeks
Concentration of buprenorphine and metabolites in maternal plasma
A blood draw around the time of delivery to evaluate the association between drug concentration and neonatal opioid withdrawal syndrome outcomes.
Measured: Delivery
Concentration of buprenorphine and metabolites in cord plasma
Cord blood will be collected and used to estimate fetal exposure to buprenorphine.
Measured: Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start21 Jul 2020
- Primary completion6 Nov 2024
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-Related DisordersStudies 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
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- T. John Winhusen, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
- Responsible party
- Sponsor-investigator, T. John Winhusen, PhD, University of Cincinnati
- Investigators
- T. John Winhusen, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911466
- Sponsor's protocol ID
- 2019-0429-2
- Other IDs
- UG1DA013732
- Acronym
- MOMs-CMA
- Status last verified
- Mar 2026
- First submitted
- 9 Apr 2019
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be transmitted by the study Data and Statistics Center to the designated party for de-identification, posting, storing, and archiving on NIDA's Data Share website. Data Share is an online repository of data from studies funded by the National Institute on Drug Abuse. All de-identified individual participant data is expected to be made available.
Publications
Kropp FB, Smid MC, Lofwall MR, Wachman EM, Martin PR, Murphy SM, Wilder CM, Winhusen TJ. Collaborative care programs for pregnant and postpartum individuals with opioid use disorder: Organizational characteristics of sites participating in the NIDA CTN0080 MOMs study. J Subst Use Addict Treat. 2023 Jun;149:209030. doi: 10.1016/j.josat.2023.209030. Epub 2023 Apr 4.
PubMed 37023858
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): a Pragmatic Randomized Trial Comparing Extended-release and Daily Buprenorphine Formulations: Conceptual Model Assessments (CMA) Sub-study
- ClinicalTrials.gov ID
- NCT03911466
- Acronym / sponsor ID
- MOMs-CMA / 2019-0429-2
- Conditions
- Opioid-Related Disorders, Drug Addiction, Pregnancy Related, Substance Abuse, Drug Abuse, Neonatal Abstinence Syndrome
- Keywords
- CTN-0080, clinical trials network, medication assisted treatment, pharmacokinetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- T. John Winhusen, PhDUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 11 Apr 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 sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Participants in MOMs will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanisms by which extended-release buprenorphine (BUP-XR), may improve mother-infant outcomes, compared to sublingual buprenorphine (BUP-SL). The additional data collected in this sub-study will be combined with data from the main MOMs trial.
It is hypothesized that: (1) the buprenorphine blood levels will vary, depending on which formulation of buprenorphine was received, (2) the variation in buprenorphine blood levels will be associated with fetal behavior (including fetal heart rate variability) (3) the variation in buprenorphine blood levels will be associated with differences in mother outcomes (including medication adherence and illicit opioid use) (4) the variation in buprenorphine blood levels and in fetal behavior will be associated with infant outcomes (including neonatal opioid withdrawal syndrome and infant development).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BUP-XR | – | Drug: Buprenorphine InjectionWeekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). |
| BUP-SL | – | Drug: Buprenorphine Sublingual ProductDaily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.). |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants in this study were recruited from the main CTN-0080 MOMs (NCT03918850) study sample.
Key inclusion criteria (1 listed)
- Participating in the MOMs trial (Unique protocol ID: 2019-0429-1)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Buprenorphine InjectionAlso: CAM2038Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR). | Drug | BUP-XR |
| Buprenorphine Sublingual ProductAlso: Subutex, SuboxoneSublingual buprenorphine (BUP-SL), administered daily. | Drug | BUP-SL |
Primary outcome
Cmin of buprenorphine and metabolites in plasma
Time frame: 2 weeks post-randomization
A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model.
Cmin of buprenorphine and metabolites in plasma
Time frame: 4 weeks post-randomization
A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model.
Fetal heart rate variability
Time frame: Estimated gestational age (EGA) approximately 36 weeks
This is the measure of primary interest from the fetal evaluation (non-stress test and biophysical profile).
Cmin of buprenorphine and metabolites in plasma
Time frame: Estimated gestational age (EGA) approximately 36 weeks
A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate trough-to-peak fluctuation for the conceptual model.
Cmax of buprenorphine and metabolites in plasma
Time frame: Estimated gestational age (EGA) approximately 36 weeks
A blood draw at the estimated time of maximum drug concentration ("peak") to evaluate trough-to-peak fluctuation for the conceptual model.
Concentration of buprenorphine and metabolites in maternal plasma
Time frame: Delivery
A blood draw around the time of delivery to evaluate the association between drug concentration and neonatal opioid withdrawal syndrome outcomes.
Concentration of buprenorphine and metabolites in cord plasma
Time frame: Delivery
Cord blood will be collected and used to estimate fetal exposure to buprenorphine.
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 16 Mar 2026.
- Derived from this study: PubMed 37023858Kropp FB, Smid MC, Lofwall MR, Wachman EM, Martin PR, Murphy SM, Wilder CM, Winhusen TJ. Collaborative care programs for pregnant and postpartum individuals with opioid use disorder: Organizational characteristics of sites participating in the NIDA CTN0080 MOMs study. J Subst Use Addict Treat. 2023 Jun;149:209030. doi: 10.1016/j.josat.2023.209030. Epub 2023 Apr 4.
- Individual participant dataSharing planned: Yes. Data will be transmitted by the study Data and Statistics Center to the designated party for de-identification, posting, storing, and archiving on NIDA's Data Share website. Data Share is an online repository of data from studies funded by the National Institute on Drug Abuse. All de-identified individual participant data is expected to be made available.
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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.
T. John Winhusen, PhD principal investigator
University of Cincinnati
12 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-Related Disorders and Drug Addiction, run by T. John Winhusen, PhD at 12 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 1 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 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Cmin of buprenorphine and metabolites in plasma (time frame: 2 weeks post-randomization). 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?
On the ClinicalTrials.gov record for NCT03911466, which also lists 1 linked publication.
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 16 Mar 2026.