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Dexmedetomidine as Adjunctive Therapy for Alcohol Withdrawal (DATA)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by University of Colorado, Denver.   Recruitment status was  Not yet recruiting

First Received on July 8, 2009.   Last Updated on July 9, 2009   History of Changes
Sponsor: University of Colorado, Denver
Collaborator: Hospira, Inc.
Information provided by: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00936377
  Purpose

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.


Condition Intervention
Acute Alcohol Withdrawal
 Drug: Dexmedetomidine
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo Controlled, Dose Escalation Study of Dexmedetomidine as Adjunctive Therapy for Alcohol Withdrawal

Resource links provided by NLM:

Drug Information available for: Dexmedetomidine Dexmedetomidine hydrochloride
U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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. [ Time Frame: Seven days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The degree of alcohol withdrawal and level of sedation. [ Time Frame: Seven days ] [ Designated as safety issue: No ]
  • The occurrence and duration of tracheal intubation. [ Time Frame: Seven days ] [ Designated as safety issue: No ]
  • The occurrence of adverse events. [ Time Frame: Seven days ] [ Designated as safety issue: Yes ]
  • The assessment of biomarkers as a method of determining acute withdrawal and whether therapy differentially impacts their expression. [ Time Frame: Seven days ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: September 2009
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexmedetomidine, low dose
Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days
 Drug: Dexmedetomidine
Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
Other Name: Precedex
Experimental: Dexmedetomidine, high dose
Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days
 Drug: Dexmedetomidine
Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days
Other Name: Precedex
Placebo Comparator: Placebo
Normal saline
 Other: Placebo
Normal saline for five days.

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00936377

Contacts
Contact: Robert MacLaren, PharmD 303-724-2622 rob.maclaren@ucdenver.edu

Locations
United States, Colorado
University of Colorado Hospital Not yet recruiting
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Hospira, Inc.
Investigators
Principal Investigator: Robert MacLaren, PharmD University of Colorado School of Pharmacy
  More Information

No publications provided

Responsible Party: Robert MacLaren, University of Colorado School of Pharmacy
ClinicalTrials.gov Identifier: NCT00936377     History of Changes
Other Study ID Numbers: COMIRB09-0406
Study First Received: July 8, 2009
Last Updated: July 9, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012



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