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

T. John Winhusen, PhD

Status and phase: Completed; Phase 3

Conditions: Neonatal Opiate Withdrawal Syndrome; Opioid-Related Disorders; Pregnancy Related; Drug Abuse; Neonatal Abstinence Syndrome; Substance Abuse; Drug Abuse in Pregnancy; Drug Addiction

Treatments: Drug: Buprenorphine Sublingual Product; Drug: Buprenorphine Injection

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT03911739

UG1DA013732 (U.S. NIH Grant/Contract)

2019-0429-3

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

BUP-XR

Experimental group

Description:

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.).

Treatment:

Drug: Buprenorphine Injection

BUP-SL

Active Comparator group

Description:

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.).

Treatment:

Drug: Buprenorphine Sublingual Product