At a glance

ClinicalIndex Comparison Record

N/ACompleted· 24 enrolled

Drug / intervention

Dexmedetomidine +1 moredrug

Likely dose

Dexmedetomidine 1.2 µgfrom 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/NCT00936377

NCT00936377N/ACompleted

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A Randomized, Double-Blind, Placebo Controlled, Dose Escalation Study of Dexmedetomidine as Adjunctive Therapy for Alcohol Withdrawal

University of Colorado, Denver·interventional·Posted Jul 10, 2009·Updated May 12, 2016

In Brief

A clinical study evaluating Dexmedetomidine and Placebo for Acute Alcohol Withdrawal. Completed, enrolled 24 participants across 1 site.

Detailed Summary

This study is designed to evaluate dexmedetomidine as adjunctive therapy of severe alcohol withdrawal of medical ICU patients. Specifically, this study will assess whether adjunctive dexmedetomidine reduces the doses of conventional agents used for alcohol withdrawal while maintaining patient comfort and safety and will explore if dexmedetomidine exhibits a dose-dependent profile of action when it is used for this indication. In addition, this study will assess the relationships between alcohol withdrawal, therapy with dexmedetomidine, and potential serum biomarkers of alcohol withdrawal.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAcute Alcohol Withdrawal

CountriesUnited States

CollaboratorsHospira, now a wholly owned subsidiary of Pfizer

Timeline

N/ACompletedFinished

20102011201220132014201520162017201820192020202120222023202420252026

First PostedJul 2009

Enrollment StartSep 2009

Primary CompletionOct 2012

TodayJul 2026

First PostedJul 10, 2009

Enrollment StartSep 1, 2009

Primary CompletionOct 1, 2012

TodayJul 2, 2026

Enrollment to primary: 3.1 yearsPosted 17.0 years ago

Interventions

Dexmedetomidinedrug

Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days

Placeboother

Normal saline for five days.