Abuse Liability of Staccato Alprazolam
Information source: Alexza Pharmaceuticals, Inc.
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Abuse Liability of Staccato Alprazolam
Intervention: alprazolam (Drug); alprazolam (Drug); placebo (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Alexza Pharmaceuticals, Inc. Official(s) and/or principal investigator(s):
Roland R Griffiths, PhD, Principal Investigator, Affiliation: Johns Hopkins University
Overall contact:
Daniel A Spyker, MD, Phone: 650-944-7272, Email: dspyker@alexza.com
Summary
Compare the abuse liabilities of Staccato Alprazolam, oral immediate-release alprazolam, and
Staccato Placebo.
Clinical Details
Official title: Abuse Liability Study of Staccato® Alprazolam for Inhalation in Subjects With Histories of Sedative Abuse
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study
Primary outcome: 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"
Secondary outcome: 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"Comparison to placebo and active controls for the percent of subjects reporting treatment emergent adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Daniel A Spyker, MD, Phone: 650-944-7272, Email: dspyker@alexza.com
Johns Hopkins University School of Medicine, Baltimore, Maryland 21224, United States; Recruiting
Roland R Griffiths, PhD, Phone: 410-550-0034, Email: rgriff@jhmi.edu
Roland R Griffiths, PhD, Principal Investigator
Additional Information
Starting date: January 2008
Ending date: December 2008
Last updated: June 2, 2008
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