MOMs-INO: Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study

Sponsor

T. John Winhusen, PhD (Other)

Overall Status

Recruiting

CT.gov ID

NCT03911739

Collaborator

National Institute on Drug Abuse (NIDA) (NIH), The Emmes Company, LLC (Industry)

200

Enrollment

Locations

Arms

63.3

Anticipated Duration (Months)

15.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Caretakers of the infants delivered by MOMs participants will be offered the opportunity to enroll in this sub-study, which is designed to evaluate the impact of extended-release buprenorphine (BUP-XR), relative to sublingual buprenorphine (BUP-SL), on infant neurodevelopment. The additional data collected in this sub-study will be combined with data from the main MOMs trial.

Condition or Disease	Intervention/Treatment	Phase
Opioid-Related Disorders Drug Addiction Pregnancy Related Substance Abuse Drug Abuse Neonatal Abstinence Syndrome Neonatal Opiate Withdrawal Syndrome Drug Abuse in Pregnancy	Drug: Buprenorphine Injection Drug: Buprenorphine Sublingual Product	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): Infant Neurodevelopmental Outcomes (INO) Sub-study

Actual Study Start Date :

Jun 14, 2021

Anticipated Primary Completion Date :

Sep 22, 2026

Anticipated Study Completion Date :

Sep 22, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BUP-XR 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 Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR). Other Names: CAM2038
Active Comparator: BUP-SL 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 Sublingual buprenorphine (BUP-SL), administered daily. Other Names: Subutex Suboxone

Arm

Intervention/Treatment

Experimental: BUP-XR

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

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

Other Names:

CAM2038

Active Comparator: BUP-SL

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

Sublingual buprenorphine (BUP-SL), administered daily.

Other Names:

Subutex

Suboxone

Outcome Measures

Primary Outcome Measures

Bayley Scales of Infant Development [24 months post-partum]
The Bayley Scales of Infant Development is considered the gold standard assessment of early child development and includes cognitive, language, fine motor, and gross motor subscales. Subscale scores each range from 1 - 19, with higher scores indicating higher performance.

Secondary Outcome Measures

Bayley Scales of Infant Development [12 months post-partum]
The Bayley Scales of Infant Development is considered the gold standard assessment of early child development and includes cognitive, language, fine motor, and gross motor subscales. Subscale scores each range from 1 - 19, with higher scores indicating higher performance.
Child Behavior Checklist [24 months post-partum]
The Child Behavior Checklist includes items that describe behavioral, emotional, and social problems that characterize preschool children.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The participant must be the caretaker of an infant that was delivered as part of the MOMs trial (Unique protocol ID: 2019-0429-1).

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zuckerberg San Francisco General	San Francisco	California	United States	94110
2	Gateway Community Services	Jacksonville	Florida	United States	32204
3	Massachusetts General Hospital HOPE Clinic	Boston	Massachusetts	United States	02114
4	Boston Medical Center	Boston	Massachusetts	United States	02118
5	University of New Mexico Milagro Clinic	Albuquerque	New Mexico	United States	87106
6	University of Cincinnati Health Perinatal Addictions Program	Cincinnati	Ohio	United States	45229
7	CODA, Inc.	Portland	Oregon	United States	97214
8	Pregnancy Recovery Center at Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania	United States	15213
9	Medical University of South Carolina	Charleston	South Carolina	United States	29425
10	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
11	University of Utah SUPeRAD Clinic	Salt Lake City	Utah	United States	84108
12	Addiction Recovery Services (ARS), Swedish Medical Center	Seattle	Washington	United States	98107
13	Marshall Health MARC Program	Huntington	West Virginia	United States	25701