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

Purpose

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).

Conditions

  • Opioid-Related Disorders
  • Drug Addiction
  • Pregnancy Related
  • Substance Abuse
  • Drug Abuse
  • Neonatal Abstinence Syndrome
  • Neonatal Opioid Withdrawal Syndrome
  • Drug Abuse in Pregnancy

Eligibility

Eligible Ages
Between 18 Years and 41 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participating in the MOMs trial (Unique protocol ID: 2019-0429-1)

Exclusion Criteria

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

More Details

Status
Active, not recruiting
Sponsor
T. John Winhusen, PhD

Study Contact