Abuse Liability of Staccato Alprazolam - Full Text View

Sponsor:	Alexza Pharmaceuticals, Inc.
Information provided by:	Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00603980

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 I

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:

Drug Information available for: Alprazolam

U.S. FDA Resources

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 February 09, 2012