Buprenorphine for Opioid Addiction during Pregnancy

(MOMs Trial)

No longer recruiting at 11 trial locations

Overseen By Ben Kropp, MSLS

Age: 18 - 65

Sex: Female

Trial Phase: Phase 3

Sponsor: T. John Winhusen, PhD

Must be taking: Buprenorphine

Must not be taking: Methadone, Naltrexone

Disqualifiers: Alcohol dependence, Severe mental disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Screening through delivery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two forms of buprenorphine, a medication for opioid addiction, in pregnant women. The goal is to determine if a weekly injection is as effective as a daily tablet in reducing illicit opioid use during pregnancy. Pregnant women diagnosed with moderate to severe opioid use disorder (OUD) may qualify. Participants must commit to regular check-ins and follow study procedures. This study could enhance treatment options for pregnant women battling opioid addiction. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on methadone or naltrexone for opioid use disorder. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that buprenorphine, available as an injection and a tablet that dissolves under the tongue, is generally safe to use during pregnancy. Studies indicate that the injection form, also known as a depot injection, does not increase risks during pregnancy, supporting earlier findings of its safety and effectiveness in treating opioid addiction in pregnant women.

For the tablet form, research confirms its safety for treating opioid dependence during pregnancy. It helps reduce cravings and improve overall well-being. Both forms of buprenorphine are recommended for pregnant women with opioid use disorder and have been linked to better outcomes for babies, such as higher birth weights and fewer complications.

Overall, both the buprenorphine injection and tablet are well-tolerated and serve as important options for managing opioid addiction during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Buprenorphine for opioid addiction during pregnancy is unique because it offers two forms of administration: a weekly injection (BUP-XR) and a daily sublingual option (BUP-SL). Unlike the standard sublingual treatments, the injection form provides a more consistent medication level, which can help reduce cravings and withdrawal symptoms with less frequent dosing. This is especially beneficial for new mothers, making it easier to manage their treatment routine while caring for a newborn. Additionally, the flexibility in dosing allows for tailored treatment based on individual needs, which can lead to better outcomes during and after pregnancy. Researchers are excited about these options as they provide more personalized and practical solutions for pregnant women battling opioid addiction.

What evidence suggests that this trial's treatments could be effective for opioid addiction during pregnancy?

Research shows that buprenorphine effectively treats opioid use disorder during pregnancy. In this trial, participants will receive either long-lasting buprenorphine injections (BUP-XR) or buprenorphine tablets that dissolve under the tongue (BUP-SL). Studies have found that both BUP-XR and BUP-SL reduce opioid use and cravings. Evidence supports that buprenorphine treatment leads to better outcomes for mothers and babies compared to no treatment. BUP-XR offers convenience by eliminating the need for daily doses. BUP-SL is effective and poses a lower risk of severe withdrawal symptoms in newborns. Both forms of buprenorphine show promise in helping pregnant women manage opioid use disorder. ^{2 3 6 7 8}

Who Is on the Research Team?

T. John Winhusen, PhD

Principal Investigator

University of Cincinnati

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 18-41 with opioid use disorder, carrying a single fetus between 6-30 weeks gestation. They must be in outpatient addiction treatment, understand English, and consent to the study. Exclusions include alcohol/sedative dependence needing detoxification, severe psychiatric conditions, certain medical issues like high liver enzymes or kidney dysfunction, incarceration or unstable circumstances.

Inclusion Criteria

Potential participants must have a single fetus pregnancy (can be based on self-report if an objective assessment is unavailable)

Potential participants must be enrolled in outpatient addiction treatment at a participating site (e.g., have completed intake)

I have been diagnosed with moderate/severe opioid use disorder and am a candidate for or currently on BUP treatment.

Exclusion Criteria

Potential participants must not have a physiological dependence on alcohol or sedatives requiring medical detoxification

Potential participants must not have a psychiatric condition that, in the judgment of the site medical clinician (MC), would make study participation unsafe or which would make treatment compliance difficult. Examples include: Suicidal or homicidal ideation requiring immediate attention, Severe, inadequately-treated mental health disorder (e.g., active psychosis, uncontrolled bipolar disorder)

Potential participants must not be enrolled in or planning to enroll in: a) a trial testing medication for managing OUD during pregnancy; b) research testing an intervention for substance use disorder or NOWS in their infant unless they are willing to provide a release for the research records.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either extended-release buprenorphine (BUP-XR) or daily sublingual buprenorphine (BUP-SL) during pregnancy

Screening through delivery

Weekly visits

Postpartum Treatment

Participants continue receiving BUP-XR or BUP-SL for 12 months postpartum, with breastfeeding participants receiving weekly BUP-XR and non-breastfeeding participants receiving monthly BUP-XR

12 months

Weekly or monthly visits depending on breastfeeding status

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Buprenorphine Injection
• Buprenorphine Sublingual Product

Trial Overview The study compares two forms of buprenorphine: extended-release injection (BUP-XR) versus sublingual product (BUP-SL), assessing their impact on both mother and infant outcomes during pregnancy. The goal is to see if BUP-XR is at least as effective as BUP-SL without increasing illicit opioid use.

How Is the Trial Designed?

Group I: BUP-XR Experimental Treatment 1 Intervention

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.).

Group II: BUP-SL Active Control 1 Intervention

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.).

Who Is Running the Clinical Trial?

T. John Winhusen, PhD

Lead Sponsor

Trials

5

Recruited

750+

The Emmes Company, LLC

Industry Sponsor

Trials

149

Recruited

1,052,000+

Peter Ronco

The Emmes Company, LLC

Chief Executive Officer since 2023

BSc from Nottingham University

Dr. Joe Sliman

The Emmes Company, LLC

Chief Medical Officer since 2020

MD from Uniformed Services University of the Health Sciences, MPH from Johns Hopkins University, BSc in Molecular and Cell Biology from Pennsylvania State University

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6881108/

Opioid use disorder in pregnancy - PMC - PubMed Central Data and experience have shown that untreated OUD during pregnancy negatively impacts the pregnant person, fetus, and subsequent child.

2. acog.org acog.org/clinical/clinical-guidance/committee-opinion/articles/2017/08/opioid-use-and-opioid-use-disorder-in-pregnancy

Opioid Use and Opioid Use Disorder in Pregnancy Buprenorphine. Recent evidence supports the use of buprenorphine for opioid use disorder treatment during pregnancy. Buprenorphine acts on the same mu-opioid ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12418730/

Monthly buprenorphine depot injection (SUBLOCADE®) for ... The clinical practice case studies highlight the experience from four pregnant patients with OUD who received monthly BUP‐XR. All four neonates ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714420300926

Medication treatment for opioid use disorder in expectant ... Relative to methadone, BUP-SL offers the advantages of lower NOWS severity in infants [9] and greater convenience for pregnant women by removing the requirement ...

5. recoveryanswers.org recoveryanswers.org/research-post/a-real-world-comparison-of-methadone-buprenorphine-for-opioid-dependent-pregnant-women/

A Real-world Comparison of Methadone & Buprenorphine ... Women treated with buprenorphine were more likely to initiate opioid agonist therapy (OAT) before or earlier in pregnancy and give birth at term to newborns ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40296235/

Monthly buprenorphine depot injection (SUBLOCADE®) ... Three sources of data illustrate that the use of monthly BUP-XR during pregnancy has demonstrated no increased risk and is consistent with the ...

7. med.stanford.edu med.stanford.edu/news/all-news/2022/11/buprenorphine-pregnancy-opioid.html

Use of buprenorphine during pregnancy better for infants than ... Researchers found that babies born to mothers who took buprenorphine for opioid use disorder overall had higher birth weight, showed fewer ...

8. bridgetotreatment.org bridgetotreatment.org/wp-content/uploads/CA_BRIDGE_FAQ_MAT-and-TIC-Pregnancy_June_2025.pdf

Medications for Addiction Treatment and Trauma-Informed ... Buprenorphine and methadone are safe and effective during pregnancy and breastfeeding. Both are recommended for treatment for opioid use disorder by ACOG. ○ ...