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Behavioural Intervention

Symptom-Based Dosing for Neonatal Abstinence Syndrome (OPTimize NOW Trial)

Phase 3

Recruiting

Led By Lori Devlin, MD

Research Sponsored by HELP for NOWS Consortium

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of birth until hospital discharge or 1 year, whichever comes first.

Awards & highlights

OPTimize NOW Trial Summary

This trial will help determine the best way to treat NOWS in babies, either through regular doses of medicine or when symptoms appear.

Who is the study for?

This trial is for babies at risk of Neonatal Opioid Withdrawal Syndrome (NOWS) who are 36 weeks gestation or older, with prenatal opioid exposure. Babies must not need respiratory support at 48 hours old, have no major birth defects, and cannot have started treatment elsewhere.Check my eligibility

What is being tested?

The study compares two methods to treat NOWS in infants: a scheduled opioid taper approach where medicine is reduced over time, and a symptom-based dosing approach that administers medication only when withdrawal symptoms appear.See study design

What are the potential side effects?

While the trial focuses on treatment approaches rather than specific medications, potential side effects may include typical reactions to opioids such as drowsiness or digestive issues if these medications are used.

OPTimize NOW Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of birth until hospital discharge or 1 year, whichever comes first.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of birth until hospital discharge or 1 year, whichever comes first.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of birth until hospital discharge or 1 year, whichever comes first. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time from birth until medically ready for discharge

Secondary outcome measures

Length of hospital stay

Receipt of pharmacologic treatment

Receipt of secondary medications

+4 more

OPTimize NOW Trial Design

2Treatment groups

Experimental Treatment

Group I: Sequence 2Experimental Treatment2 Interventions

This sequence will assign eligible participants to a three-week run-in period followed by a symptom-based dosing approach for five months followed by a three-week washout period followed by scheduled opioid taper approach for five months.

Group II: Sequence 1Experimental Treatment2 Interventions

This sequence will assign eligible participants to a three-week run-in period followed by a scheduled opioid taper approach for five months followed by a three-week washout period followed by symptom-based dosing approach for five months.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,965 Previous Clinical Trials

2,672,317 Total Patients Enrolled

2 Trials studying Neonatal Abstinence Syndrome

120 Patients Enrolled for Neonatal Abstinence Syndrome

HELP for NOWS ConsortiumLead Sponsor

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,370 Total Patients Enrolled

Media Library

Scheduled Opioid Taper Approach (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05980260 — Phase 3

Neonatal Abstinence Syndrome Research Study Groups: Sequence 1, Sequence 2

Neonatal Abstinence Syndrome Clinical Trial 2023: Scheduled Opioid Taper Approach Highlights & Side Effects. Trial Name: NCT05980260 — Phase 3

Scheduled Opioid Taper Approach (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05980260 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to submit an application for participation in this experiment?

"Individuals presenting with neonatal abstinence syndrome and between 1 hour to 48 hours in age are eligible for this trial. 480 participants will be accepted into the study overall."

Answered by AI

Has the FDA sanctioned a Symptom-based Dosing Approach?

"Given the Phase 3 trial status of this medication, with evidence to suggest both efficacy and safety, our team has rated Symptom-based Dosing Approach's security a 3 on a scale of 1-3."

Answered by AI

How widespread is the implementation of this trial?

"Currently, 9 medical sites are recruiting participants for this trial. Little Rock, Indianapolis and Jeffersonville are among them in addition to 6 other locations. To reduce the need of travelling far distances, it is advised that you choose a clinic nearby if you decide to join the study."

Answered by AI

Are there still open enrollment opportunities for this research trial?

"The clinicaltrial.gov page for this study shows that it is not currently seeking candidates; the original posting was on January 15th 2024 and the latest edit happened on July 27th 2023. However, there are presently 1439 other medical trials actively accepting volunteers."

Answered by AI

Does this research include participants aged 40 or older?

"To qualify for this trial, participants must be between 1 hour and 48 hours old. There are 373 studies available to minors and 1005 trials open to seniors."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach

2024. "Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05980260.

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