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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
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
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 weeks of gestation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 weeks of gestation
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 moreSecondary outcome measures
NAS2
NAS3
NAS4
+1 moreTrial 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
2,481 Previous Clinical Trials
2,620,773 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,273 Previous Clinical Trials
14,840,350 Total Patients Enrolled
Lauren M Jansson, MDPrincipal InvestigatorJohns Hopkins University
5 Previous Clinical Trials
250 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently pregnant and have certain pregnancy-related complications that could affect your health or the health of your baby.You have certain health problems during pregnancy that can affect the baby's development, like diabetes, thyroid issues, HIV infection, or high blood pressure.You have a problem with alcohol and meet the criteria for alcohol use disorder as defined by the DSM V guidelines.Women who have used street methadone for more than 3 days in a row and are seeking treatment.You currently have a problem with using opioids, as identified by specific criteria set by medical professionals.
Research Study Groups:
This trial has the following groups:- Group 1: Buprenorphine-naloxone treated
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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