Dexmedetomidine as Adjunctive Therapy for Alcohol Withdrawal

NCT00936377 | Completed Results

• 1 other identifier: 09-0406
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Alcohol Withdrawal

Outcome Measures

Primary Outcomes (3)

• Cumulative Lorazepam Dose Over the First Seven Days of Alcohol Withdrawal

  Seven days

• Change in 12-Hour Lorazepam Requirement Pre- and Post-Treatment

  12 hours before treatment, 12 hours after treatment on first day of starting study drug

• Change in 24-Hour Lorazepam Requirement Pre- and Post-Treatment

  24 hours before treatment, 24 hours after treatment on first day of starting study drug

Secondary Outcomes (5)

• The Degree of Alcohol Withdrawal Assessed by Clinical Institute Withdrawal Assessment (CIWA) Scores

  Every 2-4 hours for 24 hours after starting study drug

• The Occurrence of Adverse Events.

  Seven days

• Plasma Epinephrine Concentrations Across Groups Over Time

  Four days with samples measured prior to study drug and 48 and 96 hours after starting study drug

• Duration of Study Drug Administration

  The duration of study drug in hours as measured when the subject was discharged from the ICU, for up to 24 weeks

• ICU Length of Stay

  The duration of ICU stay in days as measured at time of hospital discharge, for up to 24 weeks

Study Arms (3)

Dexmedetomidine, low dose

EXPERIMENTAL

Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days

Drug: Dexmedetomidine

Dexmedetomidine, high dose

EXPERIMENTAL

Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days

Drug: Dexmedetomidine

Placebo

PLACEBO COMPARATOR

Normal saline

Other: Placebo

Interventions

Dexmedetomidine DRUG

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

Also known as: Precedex

Dexmedetomidine, high dose; Dexmedetomidine, low dose

Placebo OTHER

Normal saline for five days.

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe alcohol withdrawal defined by a CIWA score ≥ 15 and the need for at least 16 mg of lorazepam over a four-hour period. All lorazepam doses, whether oral or intravenous, will contribute to the cumulative amount.
• Patients receiving standard therapy for severe alcohol withdrawal according to a symptom-triggered alcohol withdrawal protocol. Lorazepam is the preferred benzodiazepine agent for patients requiring ICU admission due to alcohol withdrawal.
• Informed consent within 36 hours of qualifying for the study.

You may not qualify if:

• Patients \< 18 years of age or \> 85 years of age.
• Patients receiving benzodiazepine therapy for purposes other than alcohol withdrawal (e.g. sedation).
• Patients with alcohol withdrawal not requiring ICU admission.
• Patients receiving epidural administration of medication(s).
• Comatose patients by metabolic or neurologic affectation.
• Patients with active myocardial ischemia or second- or third-degree heart block.
• Moribund state with planned withdrawal of life support.
• Patients with known or suspected severe adverse reactions to dexmedetomidine (or clonidine).
• Pregnant females or females suspected of being pregnant

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Hospira, now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Related Publications (2)

• 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.

  PMID: 25638740 DERIVED

• 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.

  PMID: 24351375 DERIVED

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Robert MacLaren
• Organization: University of Colorado

rob.maclaren@ucdenver.edu

303 724-2622

Study Officials

• Robert MacLaren, PharmD

  University of Colorado School of Pharmacy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 10, 2009
• Study Start: September 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 12, 2016
• Results First Posted: May 12, 2016

Record last verified: 2016-04

Locations

US (1)