Flumazenil Reversal of Oral Triazolam

NCT00695630 | Completed Phase 1

• 3 other identifiers: 30779U54DE014254T32007132
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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).

Conditions

Dental Anxiety

Keywords

conscious sedation; dental anxiety/drug therapy; behavior/drug effects

Outcome Measures

Primary Outcomes (1)

• Observer Assessment of Alertness/Sedation

  360 minutes

Secondary Outcomes (1)

• BIS

  360 minutes

Study Arms (2)

1

EXPERIMENTAL

Flumazenil 2mL

Drug: Flumazenil

2

PLACEBO COMPARATOR

Saline, 2mL SM

Drug: Placebo

Interventions

Flumazenil DRUG

2 mL, 0.2 mg SM

1

Placebo DRUG

2 mL sterile saline SM

2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Dental Fears Research Clinic

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• 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. doi: 10.1097/01.jcp.0000186742.07148.da.

  PMID: 16415697 BACKGROUND

MeSH Terms

Interventions

Flumazenil

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Peter M Milgrom, DDS

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 9, 2008
• First Posted: June 12, 2008
• Study Start: September 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: June 12, 2008

Record last verified: 2008-06

Locations

US (1)