Clinical trial

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

Name

2019-0429-3

Description

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.

Trial arms

Trial start

2021-06-14

Estimated PCD

2025-01-31

Trial end

2025-01-31

Status

Recruiting

Phase

Early phase I

Treatment

Buprenorphine Injection

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

Arms:

BUP-XR

Other names:

CAM2038

Buprenorphine Sublingual Product

Sublingual buprenorphine (BUP-SL), administered daily.

Arms:

BUP-SL

Other names:

Subutex, Suboxone

Size

200

Primary endpoint

Bayley Scales of Infant Development

24 months post-partum

Eligibility criteria

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: -

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

Updated at

2023-09-26

1 organization

1 product

6 indications

Organization

T. John Winhusen, PhD

Product

Buprenorphine

Indication

Opioid-Related Disorders

Indication