Summary

Eligibility
for females ages 18-41 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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). 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).

Official Title

NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): a Pragmatic Randomized Trial Comparing Extended-release and Daily Buprenorphine Formulations: Conceptual Model Assessments (CMA) Sub-study

Keywords

Opioid-Related Disorders Drug Addiction Pregnancy Related Substance Abuse Drug Abuse Neonatal Abstinence Syndrome Neonatal Opioid Withdrawal Syndrome Drug Abuse in Pregnancy CTN-0080 clinical trials network medication assisted treatment pharmacokinetics Syndrome Substance-Related Disorders Substance Withdrawal Syndrome Buprenorphine Buprenorphine Injection Buprenorphine Sublingual Product BUP-XR BUP-SL

Eligibility

You can join if…

Open to females ages 18-41

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

You CAN'T join if...

Locations

  • Zuckerberg San Francisco General accepting new patients
    San Francisco California 94110 United States
  • University of Utah SUPeRAD Clinic accepting new patients
    Salt Lake City Utah 84108 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Theresa Winhusen, PhD
ID
NCT03911466
Phase
Phase 3
Study Type
Interventional
Last Updated