NCT00603980

Staccato Alprazolam Abuse Liability

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Alexza Pharmaceuticals, Inc. · Unknown
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

The Phase 1 clinical study compared the abuse liabilities of Staccato Alprazolam, oral immediate-release alprazolam, and Staccato Placebo in 14 subjects with a history of sedative abuse. Subjects who met the inclusion/exclusion criteria received 2 mg of oral alprazolam and matching placebo over 2 sessions. Those who demonstrated greater liking for alprazolam versus placebo were eligible to participate in the study.

Conditions

• Abuse Liability of Staccato Alprazolam

Interventions

Type	Name	Description
DRUG	Inhaled placebo + oral placebo	Inhaled Staccato placebo + oral placebo
DRUG	Inhaled alprazolam 0.5 mg	Inhaled Staccato alprazolam 0.5 mg + oral placebo
DRUG	Inhaled alprazolam 1 mg	Inhaled Staccato alprazolam 1 mg + oral placebo
DRUG	Inhaled alprazolam 2 mg	Inhaled Staccato alprazolam 2 mg + oral placebo
DRUG	Oral alprazolam 1 mg	Oral alprazolam 1 mg + Inhaled placebo
DRUG	Oral alprazolam 2 mg	Oral alprazolam 2 mg + Inhaled placebo
DRUG	Oral alprazolam 4 m	Oral alprazolam 4 mg + Inhaled placebo
DRUG	Oral alprazolam 2 mg qualifying session	Qualifying session (2 mg oral alprazolam)
DRUG	Oral placebo qualifying session	Qualifying control session (oral placebo)

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2008-01-29
• Last updated: 2020-01-02
• Results posted: 2020-01-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study