CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Buprenorphinedrug
Likely dose
Buprenorphine 0.075 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03608696
NCT03608696Phase 2Completed
CompareCT.gov

Modeled Dose Exposure of Sublingual Buprenorphine in the Neonatal Opioid Abstinence Syndrome

Thomas Jefferson University·interventional·Posted Aug 1, 2018·Updated Feb 11, 2022

In Brief

A Phase 2 clinical trial evaluating Buprenorphine for Neonatal Abstinence Syndrome and Neonatal Opiate Withdrawal Syndrome. Completed, enrolled 10 participants across 1 site.

Detailed Summary

Neonatal withdrawal syndrome is a series of signs and symptoms in infants exposed to opioids in utero. Buprenorphine has demonstrated a 40% reduction in length of pharmacologic treatment compared to oral morphine. These results were with an empirically derived dose. This study will use pharmacokinetic modeling-informed dosing to clarify the dose/response relationship and use a rational approach to define an optimal dose regimen. The clinical trial will be open label, single arm design with a goal of initial testing of a new dosing regimen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeonatal Abstinence Syndrome, Neonatal Opiate Withdrawal Syndrome
CountriesUnited States
CollaboratorsChiesi Farmaceutici S.p.A.

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 1, 2018
Enrollment StartAug 29, 2018
Primary CompletionJul 11, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.9 years ago

Interventions

Buprenorphinedrug

buprenorphine 0.075 mg/ml solution