Abuse Liability of Staccato Alprazolam - Tabular View

Tracking Information

First Received Date ^ICMJE

January 17, 2008

Last Updated Date

March 20, 2009

Start Date ^ICMJE

January 2008

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00603980 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Abuse Liability of Staccato Alprazolam

Official Title ^ICMJE

Abuse Liability Study of Staccato® Alprazolam for Inhalation in Subjects With Histories of Sedative Abuse

Brief Summary

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

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study

Condition ^ICMJE

Abuse Liability of Staccato Alprazolam

Intervention ^ICMJE

Drug: alprazolam
Drug: placebo

Study Arms / Comparison Groups

Experimental: Low dose
Experimental: Middle dose
Experimental: High dose
Active Comparator: Low dose
Active Comparator: Middle dose
Active Comparator: High dose
Placebo Comparator: Double placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

January 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00603980

Responsible Party

Daniel A. Spyker, MD / Sr Director, Drug Safety & Pharmacovigilance, Alexza Pharmaceuticals, Inc

Study ID Numbers ^ICMJE

AMDC-002-102, 22 January 2008

Study Sponsor ^ICMJE

Alexza Pharmaceuticals, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Roland R Griffiths, PhD

Johns Hopkins University

Information Provided By

Alexza Pharmaceuticals, Inc.

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP