# The Ohio Valley Node of the Clinical Trials Network

> **NIH NIH UG1** · UNIVERSITY OF CINCINNATI · 2021 · $900,438

## Abstract

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
 1.1 Study Objectives
CTN?0080 includes four objectives:
* Primary Objective: To evaluate the impact of treating opioid use disorder (OUD) in pregnant
 women with extended-release (XR) buprenorphine (BUP), compared to sublingual (SL)
 BUP, on mother and infant outcomes. Hypothesized outcomes are that the BUP-XR, relative
 to the BUP-SL, group will:
 1) not have greater illicit opioid use during pregnancy (primary, non-inferiority);
 2) have lower infant neonatal opioid withdrawal syndrome (NOWS) severity (key
 secondary, superiority); and
 3) not have greater postpartum illicit opioid use (key secondary, non-inferiority).
* Secondary Objective: To test conceptual models of the mechanisms by which BUP-XR may
 improve mother-infant outcomes, relative to BUP-SL.
* Tertiary Objective: To determine the economic value of utilizing BUP-XR, relative to BUP-
 SL, to treat pregnant women.
* Quaternary Objective: To evaluate the impact of BUP-XR, relative to BUP-SL, on infant
neurodevelopment.
 1.2 Study Design
This is an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial. Eligible
participants will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, estimated
gestational age (EGA) at time of randomization (6 weeks-18 weeks vs. 19 weeks-30 weeks), and whether
they are on BUP-SL at the time of randomization (yes vs. no). Participants will be provided with study
medication and attend weekly medication visits through 12 months postpartum. Participants will be
invited to participate in the conceptual model assessment (CMA) sub-study, which will be used to
evaluate the MOMs conceptual models. Infant caregivers will be invited to participate in the infant
neurodevelopmental outcomes (INO) sub-study, which will include a 24-month child assessment. The
INO data will be locked separately from the rest of the CTN?0080 database to allow CTN?0080 database
lock following collection of the final (non-INO) CTN-0080 data point.
 1.3 Study Population
Approximately 200 pregnant women, recruited from approximately 10 sites, will be randomized into the
trial. Sites that provide BUP to pregnant women in an office-based setting, offer BUP treatment
following delivery for ≥12 months, and admit enough potentially eligible women to meet the target
randomization rate (1.25 per month) are eligible. The study population will include pregnant women
who have an EGA of 6-30 weeks at randomization, and, in the judgment of the treating provider, are
good candidates for BUP-maintenance treatment. All randomized participants will be encouraged to
participate in the CMA and INO sub-studies.
 1.4 Treatments
Participants randomized to BUP-XR will receive a weekly formulation of CAM2038 during pregnancy.
During the 12-month postpartum phase, women who are breastfeedi...

## Key facts

- **NIH application ID:** 10441986
- **Project number:** 3UG1DA013732-22S3
- **Recipient organization:** UNIVERSITY OF CINCINNATI
- **Principal Investigator:** T John WINHUSEN
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $900,438
- **Award type:** 3
- **Project period:** 2021-07-01 → 2022-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10441986

## Citation

> US National Institutes of Health, RePORTER application 10441986, The Ohio Valley Node of the Clinical Trials Network (3UG1DA013732-22S3). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10441986. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*