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Opioid Partial Agonist

Buprenorphine-naloxone for Opioid Use Disorder in Infants

Phase 2
Waitlist Available
Led By Lauren M Jansson, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current opioid use disorder (OUD) as defined by DSM V criteria
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 weeks of gestation
Awards & highlights

Study Summary

This trial is testing the effects of buprenorphine-naloxone on pregnant women and their fetuses. They will study 120 pregnant women who are taking buprenorphine-naloxone as part of substance abuse treatment. They will look at the fetal neurobehavior and maternal physiology at 4 points during gestation and compare it to methadone and buprenorphine-only exposure.

Eligible Conditions
  • Maternal Opioid Use Disorder
  • Infants

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You currently have a problem with using opioids, as identified by specific criteria set by medical professionals.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 weeks of gestation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 weeks of gestation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fetal Heart Rate at 24 Weeks
Fetal Heart Rate at 28 Weeks Gestation
Fetal Heart Rate at 32 Weeks Gestation
+5 more
Secondary outcome measures
NAS2
NAS3
NAS4
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Buprenorphine-naloxone treatedExperimental Treatment2 Interventions
Participants receiving buprenorphine-naloxone treatment for opioid use disorder during pregnancy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
fetal monitoring
2018
Completed Phase 2
~50
Buprenorphine Naloxone
2018
Completed Phase 4
~60

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,467 Previous Clinical Trials
2,619,081 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,260 Previous Clinical Trials
14,820,738 Total Patients Enrolled
Lauren M Jansson, MDPrincipal InvestigatorJohns Hopkins University
5 Previous Clinical Trials
250 Total Patients Enrolled

Media Library

Buprenorphine Naloxone (Opioid Partial Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03291847 — Phase 2
Opioid Use Disorder Research Study Groups: Buprenorphine-naloxone treated
Opioid Use Disorder Clinical Trial 2023: Buprenorphine Naloxone Highlights & Side Effects. Trial Name: NCT03291847 — Phase 2
Buprenorphine Naloxone (Opioid Partial Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03291847 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Maternal Buprenorphine-naloxone Treatment and the Infant
2018. "Maternal Buprenorphine-naloxone Treatment and the Infant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03291847.
~6 spots leftby Apr 2025
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