Rapid-wean for Neonatal Opioid Withdrawal Syndrome

Central Michigan University, Detroit, MI
Neonatal Opioid Withdrawal SyndromeMorphine - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effect of two different weaning methods on the number of days of opioid treatment for infants with NOWS.

Eligible Conditions
  • Neonatal Opioid Withdrawal Syndrome

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

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1
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1
Buspirone

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: From date of birth until hospital discharge or 1 year whichever comes first

Month 24
Maternal Well-being
1 month post discharge
Maternal-Infant attachment
Month 24
Infant development
Infant growth
Infant wellness
Year 1
Length of hospital stay
Number of days of methadone treatment
Number of days of morphine treatment
Number of days of opioid treatment
Proportion of infants in each intervention arm with an atypical NNNS neurobehavioral profile
Proportion of infants who have an escalation or resumption of opioid medication during weaning
Total amounts of opioid from the first weaning dose to cessation of opioid
proportion of infants in each intervention arm with safety outcomes of seizures (clinical or EEG), excessive stool output, respiratory disturbances, and feeding tolerance
proportion of infants who experience initiation and/or escalation of second-line or third-line drugs to treat NOWS

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

2
Bridge Device
2
Pramipexole
2
Buspirone

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

Rapid-wean
1 of 2
Slow-wean
1 of 2

Active Control

502 Total Participants · 2 Treatment Groups

Primary Treatment: Rapid-wean · No Placebo Group · Phase 3

Rapid-weanActiveComparator Group · 2 Interventions: Morphine, Methadone · Intervention Types: Drug, Drug
Slow-weanActiveComparator Group · 2 Interventions: Morphine, Methadone · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from date of birth until hospital discharge or 1 year whichever comes first

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,862 Previous Clinical Trials
2,166,709 Total Patients Enrolled
1 Trials studying Neonatal Opioid Withdrawal Syndrome
300 Patients Enrolled for Neonatal Opioid Withdrawal Syndrome
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) ProgramLead Sponsor
2 Previous Clinical Trials
1,164 Total Patients Enrolled
1 Trials studying Neonatal Opioid Withdrawal Syndrome
300 Patients Enrolled for Neonatal Opioid Withdrawal Syndrome
Abbot Laptook, MDPrincipal InvestigatorWomen and Infants Hospital of Rhode Island
5 Previous Clinical Trials
1,210 Total Patients Enrolled
Abhik Das, PhDPrincipal InvestigatorRTI International
30 Previous Clinical Trials
181,479 Total Patients Enrolled
Adam Czynski, DOPrincipal InvestigatorConnecticut Children's Medical Center

Eligibility Criteria

Age Any Age · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The hospital treats at least 12 babies each year who were exposed to opioids.
References

Frequently Asked Questions

What are the conditions that Rapid-wean is mostly used to treat?

"Rapid-wean is an effective therapeutic procedure for patients struggling with pain and opioid addiction." - Anonymous Online Contributor

Unverified Answer

How often are there side effects associated with Rapid-wean?

"There is some evidence, from both Phase 3 clinical trials and other data sources, to support the Rapid-wean intervention's safety." - Anonymous Online Contributor

Unverified Answer

Are there any geographical restrictions to participating in this research?

"There are 28 enrolling patients for this trial at locations including University of Arizona in Tucson, Ochsner Baptist Clinical Trials Unit in New Orleans, and University of Massachusetts Memorial Medical Center-West Campus in Worcester." - Anonymous Online Contributor

Unverified Answer

Are people with the required medical condition still able to enroll in this research trial?

"That is correct, the online information from clinicaltrials.gov affirms that this clinical trial is still looking for willing participants. September 8th, 2020 is when the study was first announced, with the latest update happening on June 22nd, 2022. So far, 502 individuals are needed for the 28 different sites." - Anonymous Online Contributor

Unverified Answer

What other medical studies have included Rapid-wean in their research?

"As of now, there are 69 ongoing clinical trials for Rapid-wean, 18 of which are in the third and final phase. Most of the research is conducted in Amersfoort, Noord Holland, but there are a total of 165 locations running trials for Rapid-wean." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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