Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study (MOMs-CMA)

T. John Winhusen, PhD

Status and phase: Completed; Phase 3

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

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

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT03911466

UG1DA013732 (U.S. NIH Grant/Contract)

2019-0429-2

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). Participants in MOMs will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanisms by which extended-release buprenorphine (BUP-XR), may improve mother-infant outcomes, compared to sublingual buprenorphine (BUP-SL). The additional data collected in this sub-study will be combined with data from the main MOMs trial.

It is hypothesized that: (1) the buprenorphine blood levels will vary, depending on which formulation of buprenorphine was received, (2) the variation in buprenorphine blood levels will be associated with fetal behavior (including fetal heart rate variability) (3) the variation in buprenorphine blood levels will be associated with differences in mother outcomes (including medication adherence and illicit opioid use) (4) the variation in buprenorphine blood levels and in fetal behavior will be associated with infant outcomes (including neonatal opioid withdrawal syndrome and infant development).

Enrollment: 97 patients

Sex: Female

Ages: 18 to 41 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participating in 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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97 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