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

a study on Opioid-Related Disorders Drug Addiction Pregnancy Substance Abuse Drug Use Neonatal Abstinence Syndrome Drug Abuse in Pregnancy Opioid Use

Summary

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). 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.

Official Title

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

Keywords

Opioid-Related Disorders Drug Addiction Pregnancy Related Substance Abuse Drug Abuse Neonatal Abstinence Syndrome Neonatal Opiate 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…

  • The participant must be the caretaker of an infant that was delivered as part of the

MOMs trial (Unique protocol ID: 2019-0429-1).

You CAN'T join if...

Locations

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

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Theresa Winhusen, PhD
ID
NCT03911739
Phase
Phase 3
Study Type
Interventional
Last Updated