CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
Dose Response Curve Placebo +5 moredrug
Likely dose
Dose Response Curve N-acetylcysteine 50 mg/kgfrom 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/NCT04562597
NCT04562597Phase 2Completed
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A Pilot Trial to Determine the Effective Dose of N-acetylcysteine for Opioid Reduction in Patients Undergoing Spine Surgery.

Medical University of South Carolina·interventional·Posted Sep 24, 2020·Updated Feb 14, 2023

In Brief

A Phase 2 clinical trial evaluating Dose Response Curve Placebo, Dose Response Curve N-acetylcysteine 50 mg/kg, and 4 other interventions for Surgery. Completed, enrolled 50 participants across 1 site.

Detailed Summary

Determine the optimal dose of IV N-acetylcysteine (NAC) to produce opioid reduction following spine surgery and estimate the difference in opioid consumption between placebo and the selected optimal dose.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSurgery
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedSep 24, 2020
Enrollment StartJan 20, 2021
Primary CompletionMay 20, 2022
Study CompletionMay 21, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.8 years ago

Interventions

Dose Response Curve Placebodrug

5 participants will be randomized to the placebo group to estimate the dose response curve and to identify the optimal dose.

Dose Response Curve N-acetylcysteine 50 mg/kgdrug

5 participants will be randomized to the N-acetylcysteine 50 mg/kg group to estimate the dose response curve and to identify the optimal dose.

Dose Response Curve N-acetylcysteine 100 mg/kgdrug

5 participants will be randomized to the N-acetylcysteine 100 mg/kg group to estimate the dose response curve and to identify the optimal dose.

Dose Response Curve N-acetylcysteine 150 mg/kgdrug

5 participants will be randomized to the N-acetylcysteine 150 mg/kg group to estimate the dose response curve and to identify the optimal dose.

Opioid Reduction with Optimal N-acetylcysteine Dosedrug

Once the optimal N-acetylcysteinedose is identified, 15 participants will be randomized to the optimal dose (50,100, or 150 mg/kg) to estimate the difference in opioid consumption between patients administered optimal N-acetylcysteine dose or placebo.

Placebodrug

15 Participants will be randomized to placebo to estimate the difference in opioid consumption between patients administered optimal N-acetylcysteine dose or placebo.