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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014