Clinical trial NCT00603980: Staccato Alprazolam Abuse Liability
Official title: Abuse Liability Study of Staccato® Alprazolam for Inhalation in Subjects With Histories of Sedative Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Abuse Liability of Staccato Alprazolam
Lead sponsor: Alexza Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-01-29
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The crossover schedule is planned according to a 7-treatment, 7-period Latin Square design due to E.J. Williams (1949), which is balanced for first-order carryover effects (Fleiss, 1986). Each subject will receive all treatments in this 7-treatment, 7- period Williams Square crossover design as suggested by Chen \& Tsong (2007). This Williams Square will include one replication by 1 subject of each of the 14 sequences
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Response to EDQ Question Number 5, "Rate the Degree to Which You Would Like to Take the Drug Again"
timeFrame: End of day for each of the 7 crossover treatments
Secondary outcomes:
measure: EDQ Question Number 2 "Rate Your Overall Liking of the Drug Effect"
timeFrame: End of day for each of the 7 crossover treatments
measure: EDQ Question Number 6 " Estimate the Amount of Money You Think the Drug You Took Today Would be Worth on the Street".
timeFrame: End of day for each of the 7 crossover treatments
measure: EDQ Question Number 1, "Rate the Overall Strength of the Drug Effect"
timeFrame: End of day for each of the 7 crossover treatments
measure: EDQ Question Number 7,"What Would You be Willing to Pay for Today's Drug?"
timeFrame: End of day for each of the 7 crossover treatments
measure: Maximum of DEQ Question 1 "Rate the Strength of the Drug Effect" (at the 10 Time Points, Predose Through 9 Hours)
timeFrame: DEQ was assessed at the 10 time points (predose through 9 hours)
measure: Maximum of DEQ Question 2 "Rate Your Liking of the Drug Effect" at the 10 Time Points (Predose Through 9 Hours)
timeFrame: DEQ was assessed at the 10 time points (predose through 9 hours)
measure: Observer Rated Questionnaire 1) Maximum of Sedation/Sleepiness
timeFrame: ORQ was assessed at the 10 time points (predose through 9 hours)
measure: Observer Rated Questionnaire 2) Maximum of Muscle Relaxation Locomotor
timeFrame: ORQ was assessed at the 10 time points (predose through 9 hours)
measure: Observer Rated Questionnaire 3) Maximum of Muscle Relaxation Non-locomotor
timeFrame: ORQ was assessed at the 10 time points (predose through 9 hours)
measure: Observer Rated Questionnaire 4) Maximum of Muscle Relaxation Posture
timeFrame: ORQ was assessed at the 10 time points (predose through 9 hours)
measure: Observer Rated Questionnaire 5) Maximum of Speech
timeFrame: ORQ was assessed at the 10 time points (predose through 9 hours)
measure: Observer Rated Questionnaire 6) Maximum of Confusion/Disorientation
timeFrame: ORQ was assessed at the 10 time points (predose through 9 hours)
measure: Observer Rated Questionnaire 7) Maximum of Stimulation/Arousal
timeFrame: ORQ was assessed at the 10 time points (predose through 9 hours)
measure: Observer Rated Questionnaire 8) Maximum of Drug Strength
timeFrame: ORQ was assessed at the 10 time points (predose through 9 hours)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Roland R Griffiths, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reissig CJ, Harrison JA, Carter LP, Griffiths RR. Inhaled vs. oral alprazolam: subjective, behavioral and cognitive effects, and modestly increased abuse potential. Psychopharmacology (Berl). 2015 Mar;232(5):871-83. doi: 10.1007/s00213-014-3721-0. Epub 2014 Sep 9.