Buprenorphine for Opioid Addiction during Pregnancy

(MOMs-CMA 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

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: 12 months postpartum

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of buprenorphine, a medication for opioid addiction, to assess their effects on mothers and their babies during pregnancy. The main goal is to understand how different forms of the medication might influence the baby's heart rate, the mother's medication use, and infant development after birth. Participants will either take buprenorphine as a daily tablet or receive it as a weekly injection. Only those already part of the main MOMs trial can join this sub-study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to important research that could lead to new treatment options for opioid addiction during pregnancy.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that buprenorphine is a safe treatment for opioid addiction during pregnancy. Studies indicate that both the injection and sublingual (under-the-tongue) forms of buprenorphine do not increase risks for pregnant women or their babies. Buprenorphine is recommended for treating opioid use disorder (OUD) in pregnancy and has been linked to healthier babies with higher birth weights compared to those whose mothers did not receive treatment.

The sublingual form, often combined with naloxone, is considered safe and has been successfully used to treat opioid dependence in pregnant women. The injection form is also well-tolerated, with data showing no increased risk during pregnancy.

Overall, both the injection and sublingual forms of buprenorphine are trusted treatments for pregnant women with OUD, helping to improve health outcomes for both mothers and their babies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for opioid addiction during pregnancy because they offer new, flexible dosing options that might better meet individual needs. The Buprenorphine Injection (BUP-XR) is particularly notable because it is administered weekly or monthly, providing a long-acting option that could improve convenience and compliance compared to daily dosing. The Buprenorphine Sublingual Product (BUP-SL), on the other hand, offers flexibility in dosing, allowing adjustments based on cravings and withdrawal symptoms, which could enhance personalized care. These features could potentially offer more effective management of opioid addiction during pregnancy and postpartum periods, addressing both medical and lifestyle needs of new mothers.

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

Research has shown that buprenorphine effectively treats opioid use disorder during pregnancy. Studies indicate that buprenorphine helps pregnant women reduce opioid use and cravings. It can also lead to better outcomes for newborns, such as less severe symptoms of neonatal opioid withdrawal syndrome (NOWS). In this trial, participants may receive the under-the-tongue form of buprenorphine (BUP-SL), which is convenient and tends to reduce NOWS more than methadone. Alternatively, participants may receive the monthly injection form (BUP-XR), which has shown promise, with clinical cases demonstrating positive results for babies when pregnant women receive this treatment. Both forms of buprenorphine target the same brain receptors to manage opioid dependence effectively. ^{1 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 expectant mothers who are already participating in the MOMs trial and have opioid use disorder. It aims to understand how different forms of buprenorphine affect both mother and infant outcomes, including withdrawal symptoms in newborns.

Inclusion Criteria

Participating in the MOMs trial (Unique protocol ID: 2019-0429-1)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either daily sublingual buprenorphine or weekly subcutaneous buprenorphine injection during pregnancy and postpartum

12 months postpartum

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of fetal heart rate variability and buprenorphine concentration in plasma

Estimated gestational age approximately 36 weeks to delivery

What Are the Treatments Tested in This Trial?

Interventions

• Buprenorphine Injection
• Buprenorphine Sublingual Product

Trial Overview The study compares extended-release buprenorphine injections (BUP-XR) with sublingual products (BUP-SL), focusing on their effects on blood levels, fetal behavior, maternal adherence to medication, illicit opioid use, and infant development.

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. samhsa.gov samhsa.gov/substance-use/treatment/options/buprenorphine

What is Buprenorphine? Side Effects, Treatment & Use Buprenorphine may be prescribed to women who are pregnant and have an OUD. Buprenorphine and methadone are considered the treatments of choice ...

8. 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 ...