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Abuse Liability of Staccato Alprazolam

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: NCT00603980
Recruitment Status : Completed
First Posted : January 29, 2008
Last Update Posted : March 24, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
Compare the abuse liabilities of Staccato Alprazolam, oral immediate-release alprazolam, and Staccato Placebo.

Condition or disease Intervention/treatment Phase
Abuse Liability of Staccato Alprazolam Drug: alprazolam Drug: placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Abuse Liability Study of Staccato® Alprazolam for Inhalation in Subjects With Histories of Sedative Abuse
Study Start Date : January 2008
Primary Completion Date : January 2009
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Alprazolam
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Comparison to placebo and active controls for the percent of subjects reporting treatment emergent adverse events [ Time Frame: 8 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 29, 2008    Key Record Dates
Last Update Posted: March 24, 2009
Last Verified: January 2009

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