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Flumazenil Reversal of Oral Triazolam

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00695630
Recruitment Status : Completed
First Posted : June 12, 2008
Last Update Posted : June 12, 2008
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
University of Washington

Tracking Information
First Submitted Date  ICMJE June 9, 2008
First Posted Date  ICMJE June 12, 2008
Last Update Posted Date June 12, 2008
Study Start Date  ICMJE September 2006
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2008)
Observer Assessment of Alertness/Sedation [ Time Frame: 360 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2008)
BIS [ Time Frame: 360 minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Flumazenil Reversal of Oral Triazolam
Official Title  ICMJE Flumazenil Rescue Strategy
Brief Summary An increase in the utilization of anesthesia and sedation medications by non-anesthesiologists, including dentists, has grown dramatically. This has been prompted, in part, by the need for pharmacological tools to address high levels of fear and anxiety about dental care among the US population and the evidence of oral health disparities among those who are fearful . Given the prevalence of dental fear in the general population and in the various populations with the greatest burden of oral diseases, effective sedation techniques are needed that are safe and effective in the hands of general dentists that make up the "front line" in the efforts to reduce oral health disparities. This study is to determine whether, when compared to a saline placebo, a single intraoral submucosal administration of the benzodiazepine antagonist flumazenil (0.2 mg) is capable of attenuating in 10 minutes or less the central nervous system (CNS) depression produced by a paradigm of stacked sublingual dosing of triazolam (3 doses of 0.25 mg over 90 minutes).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dental Anxiety
Intervention  ICMJE
  • Drug: Flumazenil
    2 mL, 0.2 mg SM
  • Drug: Placebo
    2 mL sterile saline SM
Study Arms  ICMJE
  • Experimental: 1
    Flumazenil 2mL
    Intervention: Drug: Flumazenil
  • Placebo Comparator: 2
    Saline, 2mL SM
    Intervention: Drug: Placebo
Publications * Jackson DL, Milgrom P, Heacox GA, Kharasch ED. Pharmacokinetics and clinical effects of multidose sublingual triazolam in healthy volunteers. J Clin Psychopharmacol. 2006 Feb;26(1):4-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2008)
14
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ASA I

Exclusion Criteria:

  • Use of benzodiazepines, anxiolytics or any other medications that would interact with either triazolam's or flumazenil's metabolism or clinical effect (including herbals) within four weeks of the study
  • Body mass index (BMI) no less than 15 kg/m2 and no greater than 30 kg/m2
  • Pregnancy or not currently using pharmacologic methods of birth control
  • Allergy or sensitivity to benzodiazepines
  • History of a seizure disorder; AND
  • Chronic tobacco use.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00695630
Other Study ID Numbers  ICMJE 30779
U54DE014254 ( U.S. NIH Grant/Contract )
T32007132
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peter Milgrom/Professor of Dental Public Health Sciences, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Peter M Milgrom, DDS University of Washington
PRS Account University of Washington
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP