Dexmedetomidine as Adjunctive Therapy for Alcohol Withdrawal

Acute Alcohol Withdrawal Clinical Trial

— DATA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00936377
• Other study ID #: 09-0406
• Status: Completed
• Phase: N/A
• First received: July 8, 2009
• Last updated: November 20, 2012
• Start date: September 2009
• Est. completion date: October 2012

Study information

• Verified date: July 2009
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

The objectives of this randomized, double-blind, placebo controlled, dose escalation study are a) to determine if adding dexmedetomidine to symptom-triggered, standard therapy of severe alcohol withdrawal reduces the dose requirements of conventional sedatives, analgesics, and neuroleptics; maintains patient comfort and safety; and prevents and shortens tracheal intubation; b) to explore whether dexmedetomidine acts in a dose-dependent manner to reduce the dose requirements of conventional sedatives, analgesics, and neuroleptics while maintaining patient comfort; and c) determine the association between alcohol withdrawal and potential serum biomarkers of alcohol withdrawal and assess whether these are expressed differently when dexmedetomidine is used as adjunctive therapy. Dexmedetomidine will be added to existing sedative therapies in an effort to decrease the use of these agents while maintaining patient comfort. The study will randomize twenty-four patients in a double-blind manner to receive placebo or dexmedetomidine at doses of 0.4 or 1.2 µg/kg per hour for a maximum duration of five days. All patients will be managed using an existing institution-specific, symptom-triggered alcohol withdrawal protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. 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.

2. 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.

3. Informed consent within 36 hours of qualifying for the study.

Exclusion Criteria:

1. Patients < 18 years of age or > 85 years of age.

2. Patients receiving benzodiazepine therapy for purposes other than alcohol withdrawal (e.g. sedation).

3. Patients with alcohol withdrawal not requiring ICU admission.

4. Patients receiving epidural administration of medication(s).

5. Comatose patients by metabolic or neurologic affectation.

6. Patients with active myocardial ischemia or second- or third-degree heart block.

7. Moribund state with planned withdrawal of life support.

8. Patients with known or suspected severe adverse reactions to dexmedetomidine (or clonidine).

9. Pregnant females or females suspected of being pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Alcohol Withdrawal

Intervention

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

Other:
• Placebo
Normal saline for five days.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Hospira, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine whether adjunctive dexmedetomidine reduces the need for conventional sedative, analgesic, and neuroleptic agents. The specific outcome of interest is the cumulative lorazepam dose over the first seven days of alcohol withdrawal.		Seven days	No
Secondary	The degree of alcohol withdrawal and level of sedation.		Seven days	No
Secondary	The occurrence and duration of tracheal intubation.		Seven days	No
Secondary	The occurrence of adverse events.		Seven days	Yes
Secondary	The assessment of biomarkers as a method of determining acute withdrawal and whether therapy differentially impacts their expression.		Seven days	No