CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 140 enrolled / 140 target
Drug / intervention
Buprenorphine Injection +1 moredrug
Likely dose
24 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03918850
NCT03918850Phase 3CompletedMonitor (2.0/mo)Completion was 16mo ago
CompareCT.gov

Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): a Pragmatic Randomized Trial Comparing Extended-release and Daily Buprenorphine Formulations

T. John Winhusen, PhD·interventional·Posted Apr 18, 2019·Updated Jun 4, 2026

In Brief

A Phase 3 clinical trial evaluating Buprenorphine Injection and Buprenorphine Sublingual Product for Opioid-Related Disorders and 7 related conditions. Completed, enrolled 140 participants across 12 sites.

Signals

Enrolling slower than its timeline implies

Detailed Summary

The primary objective of this study is to evaluate the impact of treating opioid use disorder (OUD) in pregnant women with extended-release buprenorphine (BUP-XR), compared to sublingual buprenorphine (BUP-SL), on mother and infant outcomes. The primary hypothesis is that the BUP-XR group will not have greater illicit opioid use than the BUP-SL group during pregnancy (non-inferiority).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-Related Disorders, Drug Addiction, Pregnancy Related, Substance Abuse, Drug Abuse, Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal Syndrome, Drug Abuse in Pregnancy
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA), The Emmes Company, LLC

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedApr 18, 2019
Enrollment StartJul 21, 2020
Primary CompletionJan 31, 2025
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 7.2 years ago

Arms & Interventions

BUP-XRexperimental

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.).

Drug: Buprenorphine Injection
BUP-SLactive_comparator

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.).

Drug: Buprenorphine Sublingual Product

Interventions

Buprenorphine Injectiondrug

Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).

Buprenorphine Sublingual Productdrug

Sublingual buprenorphine (BUP-SL), administered daily.