Official Title: “Abuse Liability Study of Staccato® Alprazolam for Inhalation in Subjects With Histories of Sedative Abuse”

Compare the abuse liabilities of Staccato Alprazolam, oral immediate-release alprazolam, and Staccato Placebo.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study

Study Primary Completion Date: January 2009

Intervention(s) in this Clinical Trial

• Drug: alprazolam
  • Staccato Alprazolam, single dose
• Drug: alprazolam
  • oral, immediate release
• Drug: placebo
  • Staccato placebo + oral placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Low dose
• Experimental: 2
  • Middle dose
• Experimental: 3
  • High dose
• Active Comparator: 4
  • Low dose
• Active Comparator: 5
  • Middle dose
• Active Comparator: 6
  • High dose
• Placebo Comparator: 7
  • Double placebo

Primary Measures

• Comparison to placebo and active controls for the categorical response to the question "Rate the degree to which you would like to take the drug again"
  • Time Frame: End of day
    Safety Issue?: No

Secondary Measures

• Comparison to placebo and active controls for the categorical response to the question "Rate the overall STRENGTH and overall LIKING of the drug effect you experienced"
  • Time Frame: End of day
    Safety Issue?: No
• Comparison to placebo and active controls for the percent of subjects reporting treatment emergent adverse events
  • Time Frame: 8 hours
    Safety Issue?: Yes

Inclusion Criteria:

• Male and female subjects between the ages of 18 to 55 years, inclusive, who have a history of substance abuse or dependence on barbiturates and/or benzodiazepine receptor agonists for their intoxicating effects

Exclusion Criteria:

• Subjects with a significant current psychiatric illness or taking any psychotropic prescription medications for therapeutic uses.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Alexza Pharmaceuticals, Inc.

Overall Clinical Trial Officials and Contacts

Roland R Griffiths, PhD Principal Investigator Johns Hopkins University  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00603980

Study ID Number: AMDC-002-102

ClinicalTrials.gov Identifier: NCT00603980

Health Authority: United States: Food and Drug Administration