Dexmedetomidine as Adjunctive Therapy for Alcohol Withdrawal
Information source: University of Colorado, Denver
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Alcohol Withdrawal
Intervention: Dexmedetomidine (Drug); Placebo (Other)
Phase: N/A
Status: Completed
Sponsored by: University of Colorado, Denver Official(s) and/or principal investigator(s):
Robert MacLaren, PharmD, Principal Investigator, Affiliation: University of Colorado School of Pharmacy
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.
Clinical Details
Official title: A Randomized, Double-Blind, Placebo Controlled, Dose Escalation Study of Dexmedetomidine as Adjunctive Therapy for Alcohol Withdrawal
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: The degree of alcohol withdrawal and level of sedation.The occurrence and duration of tracheal intubation. The occurrence of adverse events. The assessment of biomarkers as a method of determining acute withdrawal and whether therapy differentially impacts their expression.
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University of Colorado Hospital, Aurora, Colorado 80045, United States
Additional Information
Starting date: September 2009
Last updated: November 20, 2012
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