Abuse Liability of Staccato Alprazolam - Full Text View

Sponsored by:	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

Drug Information available for: Alprazolam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	Abuse Liability Study of Staccato® Alprazolam for Inhalation in Subjects With Histories of Sedative Abuse

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
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Low dose	Drug: alprazolam Staccato Alprazolam, single dose
2: Experimental Middle dose	Drug: alprazolam Staccato Alprazolam, single dose
3: Experimental High dose	Drug: alprazolam Staccato Alprazolam, single dose
4: Active Comparator Low dose	Drug: alprazolam oral, immediate release
5: Active Comparator Middle dose	Drug: alprazolam oral, immediate release
6: Active Comparator High dose	Drug: alprazolam oral, immediate release
7: Placebo Comparator 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

Contacts

Contact: Daniel A Spyker, MD

650-944-7272

dspyker@alexza.com

Locations

United States, Maryland
Johns Hopkins University School of Medicine	Recruiting
Baltimore, Maryland, United States, 21224
Contact: Roland R Griffiths, PhD 410-550-0034 rgriff@jhmi.edu
Principal Investigator: Roland R Griffiths, PhD

Sponsors and Collaborators

Alexza Pharmaceuticals, Inc.

Investigators

Principal Investigator:

Roland R Griffiths, PhD

Johns Hopkins University

More Information

Responsible Party:	Alexza Pharmaceuticals, Inc ( Daniel A. Spyker, MD / Sr Director, Drug Safety & Pharmacovigilance )
Study ID Numbers:	AMDC-002-102, November 14, 2007
Study First Received:	January 17, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00603980
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Alprazolam

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants

Pharmacologic Actions
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009