Buprenorphine for Opioid Use Disorder in Pregnancy (MOMs-INO Trial)

Phase 3

Recruiting

Research Sponsored by T. John Winhusen, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must not have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months post-partum

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial will compare the effects of two different types of medication to treat opioid addiction in pregnant women on their infants' neurodevelopment.

Who is the study for?

This trial is for caretakers of infants born to mothers who were part of the MOMs trial, which looked at opioid use disorder treatments during pregnancy. The study focuses on how two forms of buprenorphine affect the baby's brain development.

What is being tested?

The sub-study compares extended-release buprenorphine injections (BUP-XR) with sublingual products (BUP-SL) to see their impact on infant neurodevelopment. It extends research from the main MOMs trial involving expectant mothers with opioid addiction.

What are the potential side effects?

While specific side effects in infants are not detailed here, buprenorphine can sometimes cause drowsiness, respiratory issues, and feeding difficulties. Close monitoring by healthcare providers is essential.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months post-partum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months post-partum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months post-partum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bayley Scales of Infant Development

Secondary study objectives

Child Behavior Checklist

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BUP-XRExperimental Treatment1 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-SLActive Control1 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.).

0 / 1Eligibility criteria met