Phase 1 N=31 Randomized Quadruple-blind Treatment

Staccato Alprazolam Abuse Liability

Abuse Liability of Staccato Alprazolam

Bottom Line

View on ClinicalTrials.gov: NCT00603980 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2020

Primary outcome: Primary: Response to EDQ Question Number 5, "Rate the Degree to Which You Would Like to Take the Drug Again" — 0; 1.714; 2.143; 2.286 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Inhaled placebo + oral placebo (Drug); Inhaled alprazolam 0.5 mg (Drug); Inhaled alprazolam 1 mg (Drug); Inhaled alprazolam 2 mg (Drug); Oral alprazolam 1 mg (Drug); Oral alprazolam 2 mg (Drug); Oral alprazolam 4 m (Drug); Oral alprazolam 2 mg qualifying session (Drug); Oral placebo qualifying session (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Nova Pneuma Inc.
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Response to EDQ Question Number 5, "Rate the Degree to Which You Would Like to Take the Drug Again"	0; 1.714; 2.143; 2.286; 1.00; 1.714	—
SECONDARY EDQ Question Number 2 "Rate Your Overall Liking of the Drug Effect"	1.679; 4.214; 4.429; 4.607; 2.571; 4.857	—
SECONDARY EDQ Question Number 6 " Estimate the Amount of Money You Think the Drug You Took Today Would be Worth on the Street".	1.750; 3.571; 7.071; 8.714; 2.857; 4.286	—
SECONDARY EDQ Question Number 1, "Rate the Overall Strength of the Drug Effect"	1.429; 3.536; 4.821; 5.429; 2.893; 4.143	—
SECONDARY EDQ Question Number 7,"What Would You be Willing to Pay for Today's Drug?"	1.607; 3.821; 4.571; 5.179; 2.964; 4.107	—
SECONDARY Maximum of DEQ Question 1 "Rate the Strength of the Drug Effect" (at the 10 Time Points, Predose Through 9 Hours)	1.571; 3.143; 4.714; 5.536; 3.036; 4.250	—
SECONDARY Maximum of DEQ Question 2 "Rate Your Liking of the Drug Effect" at the 10 Time Points (Predose Through 9 Hours)	1.607; 3.500; 4.536; 5.536; 2.893; 4.250	—
SECONDARY Observer Rated Questionnaire 1) Maximum of Sedation/Sleepiness	2.250; 3.679; 4.607; 4.714; 3.929; 4.000	—
SECONDARY Observer Rated Questionnaire 2) Maximum of Muscle Relaxation Locomotor	2.464; 2.964; 4.643; 6.357; 2.821; 3.571	—
SECONDARY Observer Rated Questionnaire 3) Maximum of Muscle Relaxation Non-locomotor	2.536; 3.036; 4.607; 6.393; 2.714; 3.786	—
SECONDARY Observer Rated Questionnaire 4) Maximum of Muscle Relaxation Posture	2.750; 2.893; 3.964; 6.250; 2.929; 2.929	—
SECONDARY Observer Rated Questionnaire 5) Maximum of Speech	2.214; 2.893; 4.786; 6.393; 3.071; 3.071	—
SECONDARY Observer Rated Questionnaire 6) Maximum of Confusion/Disorientation	1.929; 2.821; 4.893; 6.429; 3.393; 3.107	—
SECONDARY Observer Rated Questionnaire 7) Maximum of Stimulation/Arousal	3.964; 3.964; 3.964; 3.964; 3.964; 3.964	—
SECONDARY Observer Rated Questionnaire 8) Maximum of Drug Strength	2.786; 1.714; 4.571; 6.321; 3.000; 3.929	—

Summary

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

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00603980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.