Abuse Liability of Staccato Alprazolam

This study has been completed.
Sponsor:
Information provided by:
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00603980
First received: January 17, 2008
Last updated: March 20, 2009
Last verified: January 2009
  Purpose

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


Condition Intervention Phase
Abuse Liability of Staccato Alprazolam
Drug: alprazolam
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Abuse Liability Study of Staccato® Alprazolam for Inhalation in Subjects With Histories of Sedative Abuse

Resource links provided by NLM:


Further study details as provided by Alexza Pharmaceuticals, Inc.:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]
  • Comparison to placebo and active controls for the percent of subjects reporting treatment emergent adverse events [ Time Frame: 8 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 14
Study Start Date: January 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Low dose
Drug: alprazolam
Staccato Alprazolam, single dose
Experimental: 2
Middle dose
Drug: alprazolam
Staccato Alprazolam, single dose
Experimental: 3
High dose
Drug: alprazolam
Staccato Alprazolam, single dose
Active Comparator: 4
Low dose
Drug: alprazolam
oral, immediate release
Active Comparator: 5
Middle dose
Drug: alprazolam
oral, immediate release
Active Comparator: 6
High dose
Drug: alprazolam
oral, immediate release
Placebo Comparator: 7
Double placebo
Drug: placebo
Staccato placebo + oral placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603980

Locations
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Alexza Pharmaceuticals, Inc.
Investigators
Principal Investigator: Roland R Griffiths, PhD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Daniel A. Spyker, MD / Sr Director, Drug Safety & Pharmacovigilance, Alexza Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00603980     History of Changes
Other Study ID Numbers: AMDC-002-102, 22 January 2008
Study First Received: January 17, 2008
Last Updated: March 20, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alprazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014