Dexmedetomidine as Adjunctive Therapy for Alcohol Withdrawal
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.
Timeline
- Start
- 2009-09
- Primary completion
- 2012-10
- Completion
- 2012-10
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Dexmedetomidine, Low Dose vs Placebo; p = 0.64; Wilcoxon (Mann-Whitney) NCT00936377 ↗
registry analysis (superiority or other test); Dexmedetomidine, Low Dose vs Placebo; p = 0.05; Wilcoxon (Mann-Whitney) NCT00936377 ↗
registry analysis (superiority or other test); Dexmedetomidine, Low Dose vs Placebo; p = 0.066; Wilcoxon (Mann-Whitney) NCT00936377 ↗
Publications
- Reynolds PM, Mueller SW, MacLaren R. A comparison of dexmedetomidine and placebo on the plasma concentrations of NGF, BDNF, GDNF, and epinephrine during severe alcohol withdrawal. Alcohol. 2015 Feb;49(1):15-9. doi: 10.1016/j.alcohol.2014.11.006. Epub 2015 Jan 22.
- Mueller SW, Preslaski CR, Kiser TH, Fish DN, Lavelle JC, Malkoski SP, MacLaren R. A randomized, double-blind, placebo-controlled dose range study of dexmedetomidine as adjunctive therapy for alcohol withdrawal. Crit Care Med. 2014 May;42(5):1131-9. doi: 10.1097/CCM.0000000000000141.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexmedetomidine | Other / unclassified | 0.4 ug/kg | — |
| Subject | Dexmedetomidine | Other / unclassified | 1.2 ug/kg | — |