Staccato Alprazolam Abuse Liability

December 29, 2019 updated by: Alexza Pharmaceuticals, Inc.

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

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

Study Overview

Status

Completed

Conditions

Abuse Liability of Staccato Alprazolam

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Maryland
  - Baltimore, Maryland, United States, 21224
    - Johns Hopkins University School Of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment sequence 1 Sequence 1: Q, 1, 2, 7, 3, 6, 4, 5; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 1=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg	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)
Other: Treatment sequence 2 Sequence Q, 2: 2, 3, 1, 4, 7, 5, 6; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 1=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg	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)
Other: Treatment sequence 3 Sequence 3: Q, 3, 4, 2, 5, 1, 6, 7; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 1=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg	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)
Other: Treatment sequence 4 Sequence 4: Q, 4, 5, 3, 6, 2, 7, 1; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 1=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg	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)
Other: Treatment sequence 5 Sequence 5: Q, 5, 6, 4, 7, 3, 1, 2; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 1=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg	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)
Other: Treatment sequence 6 Sequence 6: Q, 6, 7, 5, 1, 4, 2, 3; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 1=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg	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)
Other: Treatment sequence 7 Sequence 7: Q, 7, 1, 6, 2, 5, 3, 4; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 1=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg	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)
Other: Treatment sequence 8 Sequence 8: Q, 5, 4, 6, 3, 7, 2, 1; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 1=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg	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)
Other: Treatment sequence 9 Sequence 9: Q, 6, 5, 7, 4, 1, 3, 2; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 1=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg	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)
Other: Treatment sequence 10 Sequence 10: Q, 7, 6, 1, 5, 2, 4, 3; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 1=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg	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)
Other: Treatment sequence 11 Sequence 11: Q, 1, 7, 2, 6, 3, 5, 4; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 1=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg	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)
Other: Treatment sequence 12 Sequence 12: Q, 2, 1, 3, 7, 4, 6, 5; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 11=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg	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)
Other: Treatment sequence 13 Sequence 13: Q, 3, 2, 4, 1, 5, 7, 6; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 1=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg	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)
Other: Treatment sequence 14 Sequence 14: Q, 4, 3, 5, 2, 6, 1, 7; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 11=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response to EDQ Question Number 5, "Rate the Degree to Which You Would Like to Take the Drug Again" Time Frame: End of day for each of the 7 crossover treatments	The End of Day Questionnaire (EDQ) is a 7-question computerized instrument in which subjects rate the overall effect of the drug they received that day. The primary outcome measure for this trial is the categorical response to question number 5, "Rate the degree to which you would like to take the drug again", with a numerical value assigned to each of the responses allowed: 0=Not at all, 1=A little, 2=Moderately, 3=Quite a bit, 4=Very much	End of day for each of the 7 crossover treatments

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EDQ Question Number 2 "Rate Your Overall Liking of the Drug Effect" Time Frame: End of day for each of the 7 crossover treatments	The within patient rank (1-7) of End of Day question number 2 (of primary interest), "Rate your overall liking of the drug effect", response options range from -4 to +4: 4=Dislike very much 3=Dislike quite a bit 2=Dislike somewhat 1=Dislike, but not very much 0=NEUTRAL OR NO EFFECT 1=Like, but not very much 2=Like somewhat 3=Like quite a bit 4=Like very much Thus a higher rank means a stronger drug effect and a lower rank a lesser drug effect	End of day for each of the 7 crossover treatments
EDQ Question Number 6 " Estimate the Amount of Money You Think the Drug You Took Today Would be Worth on the Street". Time Frame: End of day for each of the 7 crossover treatments	EDQ question number 6 (of primary interest)," Estimate the amount of money you think the drug you took today would be worth on the street".	End of day for each of the 7 crossover treatments
EDQ Question Number 1, "Rate the Overall Strength of the Drug Effect" Time Frame: End of day for each of the 7 crossover treatments	The within patient rank (1-7) of End of Day question number 1, "Rate the overall strength of the drug effect", response options range from 0-4: 0=No drug effect at all Possible mild effect, but not sure Definite mild effect Moderate strong drug effect Very strong drug effect Thus a higher rank means a stronger drug effect and a lower rank a lesser drug effect	End of day for each of the 7 crossover treatments
EDQ Question Number 7,"What Would You be Willing to Pay for Today's Drug?" Time Frame: End of day for each of the 7 crossover treatments	EDQ question number 7," What would you be willing to pay for today's drug?"	End of day for each of the 7 crossover treatments
Maximum of DEQ Question 1 "Rate the Strength of the Drug Effect" (at the 10 Time Points, Predose Through 9 Hours) Time Frame: DEQ was assessed at the 10 time points (predose through 9 hours)	The within patient rank (1-7) of Drug Effect Questionnaire question number 1: Rate the STRENGTH of the drug effect you are feeling RIGHT NOW; response options range for 0 to 4: "No drug effect at all"=0, "Possible mild effect, but not sure"=1, "Definite mild effect"=2, "Moderate strong drug effect"=3, "Very strong drug effect"=4 Maximum of the 10 time points (predose through 9 hours) Thus a higher rank means a stronger drug effect and a lower rank a lesser drug effect	DEQ was assessed at the 10 time points (predose through 9 hours)
Maximum of DEQ Question 2 "Rate Your Liking of the Drug Effect" at the 10 Time Points (Predose Through 9 Hours) Time Frame: DEQ was assessed at the 10 time points (predose through 9 hours)	The within patient rank (1-7) of maximum of the Rate your LIKING of the drug effect you are feeling RIGHT NOW; response options range from -4 to +4: "Dislike very much"=-4, "Dislike quite a bit"=-3, "Dislike somewhat"=-2, "Dislike, but not very much"=-1, "NEUTRAL OR NO EFFECT"=0, "Like, but not very much"=1, "Like somewhat"=2, "Like quite a bit"=3, "Like very much"=4 Thus a higher rank means a stronger drug effect and a lower rank a lesser drug effect	DEQ was assessed at the 10 time points (predose through 9 hours)
Observer Rated Questionnaire 1) Maximum of Sedation/Sleepiness Time Frame: ORQ was assessed at the 10 time points (predose through 9 hours)	The within patient rank (1-7) of Maximum of Observer Rated Questionnaire (ORQ): A trained and blinded staff member completed observer ratings as the subject completed the questionnaires and psychomotor assessment testing at each time point. The observer rated the subject on sedation/sleepiness, muscle relaxation, impaired posture, impaired speech, confusion/disorientation, stimulation/arousal and strength of drug effect on a five-point scale from 0 (indicating normal or no effect) to 4 (indicating extreme drug effect). Maximum of the 10 time points (predose through 9 hours) Thus a higher rank means a stronger drug effect and a lower rank a lesser drug effect	ORQ was assessed at the 10 time points (predose through 9 hours)
Observer Rated Questionnaire 2) Maximum of Muscle Relaxation Locomotor Time Frame: ORQ was assessed at the 10 time points (predose through 9 hours)	The within patient rank (1-7) of maximum of the observer rated the subject on muscle relaxation (locomotor) on a five-point scale from 0 (indicating normal or no effect) to 4 (indicating extreme drug effect). Maximum of the 10 time points (predose through 9 hours) Thus a higher rank means a stronger drug effect and a lower rank a lesser drug effect	ORQ was assessed at the 10 time points (predose through 9 hours)
Observer Rated Questionnaire 3) Maximum of Muscle Relaxation Non-locomotor Time Frame: ORQ was assessed at the 10 time points (predose through 9 hours)	The within patient rank (1-7) of maximum of the observer rated the subject on muscle relaxation (non-locomotor) on a five-point scale from 0 (indicating normal or no effect) to 4 (indicating extreme drug effect). Thus a higher rank means a stronger drug effect and a lower rank a lesser drug effect	ORQ was assessed at the 10 time points (predose through 9 hours)
Observer Rated Questionnaire 4) Maximum of Muscle Relaxation Posture Time Frame: ORQ was assessed at the 10 time points (predose through 9 hours)	The within patient rank (1-7) of maximum of the observer rated the subject on muscle relaxation (posture) on a five-point scale from 0 (indicating normal or no effect) to 4 (indicating extreme drug effect). Thus a higher rank means a stronger drug effect and a lower rank a lesser drug effect	ORQ was assessed at the 10 time points (predose through 9 hours)
Observer Rated Questionnaire 5) Maximum of Speech Time Frame: ORQ was assessed at the 10 time points (predose through 9 hours)	The within patient rank (1-7) of maximum of the observer rated the subject on speech on a five-point scale from 0 (indicating normal or no effect) to 4 (indicating extreme drug effect). Thus a higher rank means a stronger drug effect and a lower rank a lesser drug effect	ORQ was assessed at the 10 time points (predose through 9 hours)
Observer Rated Questionnaire 6) Maximum of Confusion/Disorientation Time Frame: ORQ was assessed at the 10 time points (predose through 9 hours)	The within patient rank (1-7) of maximum of the observer rated the subject on Confusion/Disorientation on a five-point scale from 0 (indicating normal or no effect) to 4 (indicating extreme drug effect). Thus a higher rank means a stronger drug effect and a lower rank a lesser drug effect	ORQ was assessed at the 10 time points (predose through 9 hours)
Observer Rated Questionnaire 7) Maximum of Stimulation/Arousal Time Frame: ORQ was assessed at the 10 time points (predose through 9 hours)	The within patient rank (1-7) of maximum of the observer rated the subject on Stimulation/Arousal on a five-point scale from 0 (indicating normal or no effect) to 4 (indicating extreme drug effect). Thus a higher rank means a stronger drug effect and a lower rank a lesser drug effect	ORQ was assessed at the 10 time points (predose through 9 hours)
Observer Rated Questionnaire 8) Maximum of Drug Strength Time Frame: ORQ was assessed at the 10 time points (predose through 9 hours)	The within patient rank (1-7) of maximum of the observer rated the subject on Drug Strength on a five-point scale from 0 (indicating normal or no effect) to 4 (indicating extreme drug effect). Thus a higher rank means a stronger drug effect and a lower rank a lesser drug effect	ORQ was assessed at the 10 time points (predose through 9 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexza Pharmaceuticals, Inc.

Investigators

Principal Investigator: Roland R Griffiths, PhD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

January 17, 2008

First Submitted That Met QC Criteria

January 28, 2008

First Posted (Estimate)

January 29, 2008

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 29, 2019

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

AMDC-002-102
22 January 2008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Abuse Liability of Staccato Alprazolam

Yale University
National Institute on Drug Abuse (NIDA); VA Connecticut Healthcare System

Recruiting

PK/PD of Oral and Vaporized Delta-9-Tetrahydrocannabinol (THC) in Older Adults

Pain, Tolerance | Oral vs Vaporized THC | Abuse Liability

United States
Prof. Eldad Yechiam
Beer Yaakov - Ness Ziona Mental Health Center

Completed

The Acute Effect of Hypericum Perforatum on Short-Term Memory in Healthy Adults

Healthy Adults | Subclinical Anxious Adults | Nootropic Potential of Hypericum and Alprazolam

Israel
Medical Research Council, South Africa

Completed

Skhokho Supporting Success: A Cluster RCT of a Multi-faceted, School-based IPV Prevention Intervention in South Africa

Partner of Victim of Physical Abuse
University of Utah
Sports Medicine Research and Testing Laboratory; Partnership for Clean Competition

Completed

Intranasal Delivery of Testosterone and Its Effect on Doping Markers (Intranasal)

Abuse of Anabolic Steroids

United States
Johns Hopkins Bloomberg School of Public Health
University of Massachusetts, Lowell; Barry University

Recruiting

Help Wanted: Evaluating a Prevention Intervention for People With Sexual Interest in Children

Child Sexual Abuse | Program Evaluation | Perpetration of Child Sexual Abuse | Prevention Intervention

United States
Total Child Health, Inc.
Eunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaborators

Unknown

A Clinical Process Support System for Primary Care to Address Family Stress (FamilyStress)

Child Abuse | Social Determinants of Health

United States
NMP Medical Research Institute
Warwick Research Services

Completed

Culturally Sensitive Cognitive Behavioural Therapy for the Survivors of Intimate Partner Violence (IPV)

Domestic Violence | Emotional Abuse | Mental Abuse of Adult

India
Sinop University

Recruiting

Otago Exercise Program Applied By Telerehabilitation (OEPABT)

Balance; Distorted | Falling | Older People--Abuse of

Turkey
T.C. ORDU ÜNİVERSİTESİ
Hacettepe University; Giresun University

Completed

The Discriminative Ability of the Four Balance Measures for Fall History

Fall | Balance; Distorted | Older People--Abuse of

Turkey
University of Kansas
Futures Without Violence

Unknown

Quality Improvement Center on Domestic Violence in Child Welfare

Domestic Violence | Multiple Forms of Child Abuse

United States

Clinical Trials on Inhaled placebo + oral placebo

National Institute on Drug Abuse (NIDA)

Completed

Effects of Cannabis Administration Routes on Human Performance and Pharmacokinetics

Cannabis Use

United States
Galecto Biotech AB

Completed

RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients

Idiopathic Pulmonary Fibrosis

United Kingdom
Synspira, Inc.

Terminated

A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis

Lung Diseases | Cystic Fibrosis | Pulmonary Disease | Antibiotic Resistant Infection | Respiratory Tract Disease | Cystic Fibrosis Pulmonary Exacerbation | Lung Inflammation | Burkholderia Infections | Lung Infection | Multi-antibiotic Resistance | Pulmonary Inflammation | Lung Infection Pseudomonal | Cystic Fibrosis... and other conditions

United Kingdom
GlaxoSmithKline

Completed

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK2339345.

Cough

United Kingdom
Aridis Pharmaceuticals, Inc.

Recruiting

SAD and MAD of Inhaled AR-501 in Health Adults and P. Aeruginosa Infected Cystic Fibrosis Subjects

Cystic Fibrosis

United States
University of Oxford
University of Birmingham

Terminated

MVA85A Aerosol vs Intramuscular Vaccination in Adults With Latent Mycobacterium Tuberculosis (M. tb) Infection

Tuberculosis

United Kingdom
Heidelberg University
Bayer

Withdrawn

Iloprost for Bridging to Heart Transplantation in PH (BRIDGE)

Pulmonary Hypertension | Chronic Left Ventricular Failure

Germany
University of California, Davis
National Multiple Sclerosis Society

Terminated

Cannabis for Spasticity in Multiple Sclerosis

Multiple Sclerosis

United States
Brooke Army Medical Center

Completed

Isopropyl Alcohol vs Ondansetron for Nausea in the Emergency Department

Nausea

United States
Advanced Brain Monitoring, Inc.
University of Iowa

Completed

Cannabis Impairment Detection Application (CIDA) (CIDA)

Alcohol Intoxication | Driving Under the Influence | Marijuana Intoxication

United States

Staccato Alprazolam Abuse Liability

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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Abuse Liability of Staccato Alprazolam

Clinical Trials on Inhaled placebo + oral placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations