Abuse Liability of Staccato AlprazolamPhase 1NCT00603980

Staccato Alprazolam Abuse Liability

A Phase 1 study testing Inhaled alprazolam 0.5 mg, Inhaled alprazolam 1 mg and Inhaled alprazolam 2 mg in people with Abuse Liability of Staccato Alprazolam, run by Nova Pneuma Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Compare the abuse liabilities of Staccato Alprazolam, oral immediate-release alprazolam, and Staccato Placebo. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Abuse Liability of Staccato Alprazolam
What is being tested?: Inhaled alprazolam 0.5 mg, Inhaled alprazolam 1 mg and Inhaled alprazolam 2 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 31 participants
Where: 1 siteUnited States
Study dates: Jan 2008to Jan 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

Subjects with a significant current psychiatric illness or taking any psychotropic prescription medications for therapeutic uses.

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested: Inhaled placebo + oral placebo, Inhaled alprazolam 0.5 mg, Inhaled alprazolam 1 mg, Inhaled alprazolam 2 mg, Oral alprazolam 1 mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Inhaled placebo + oral placeboDrug
Inhaled Staccato placebo + oral placebo
Inhaled alprazolam 0.5 mgDrug
Inhaled Staccato alprazolam 0.5 mg + oral placebo
Inhaled alprazolam 1 mgDrug
Inhaled Staccato alprazolam 1 mg + oral placebo
Inhaled alprazolam 2 mgDrug
Inhaled Staccato alprazolam 2 mg + oral placebo
Oral alprazolam 1 mgDrug
Oral alprazolam 1 mg + Inhaled placebo
Oral alprazolam 2 mgDrug
Oral alprazolam 2 mg + Inhaled placebo
Oral alprazolam 4 mDrug
Oral alprazolam 4 mg + Inhaled placebo
Oral alprazolam 2 mg qualifying sessionDrug
Qualifying session (2 mg oral alprazolam)
Oral placebo qualifying sessionDrug
Qualifying control session (oral placebo)

Study groups in NCT00603980
Study group	Role	What they receive
Treatment sequence 1	Other	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 Receives: Drug: 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
Treatment sequence 2	Other	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 Receives: Drug: 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
Treatment sequence 3	Other	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 Receives: Drug: 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
Treatment sequence 4	Other	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 Receives: Drug: 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
Treatment sequence 5	Other	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 Receives: Drug: 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
Treatment sequence 6	Other	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 Receives: Drug: 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
Treatment sequence 7	Other	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 Receives: Drug: 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
Treatment sequence 8	Other	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 Receives: Drug: 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
Treatment sequence 9	Other	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 Receives: Drug: 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
Treatment sequence 10	Other	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 Receives: Drug: 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
Treatment sequence 11	Other	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 Receives: Drug: 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
Treatment sequence 12	Other	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 Receives: Drug: 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
Treatment sequence 13	Other	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 Receives: Drug: 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
Treatment sequence 14	Other	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 Receives: Drug: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

Response to EDQ Question Number 5, "Rate the Degree to Which You Would Like to Take the Drug Again"
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
Measured: End of day for each of the 7 crossover treatments

Secondary outcomes (14)

EDQ Question Number 2 "Rate Your Overall Liking of the Drug Effect"
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
Measured: 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".
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".
Measured: End of day for each of the 7 crossover treatments
EDQ Question Number 1, "Rate the Overall Strength of the Drug Effect"
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
1. Possible mild effect, but not sure
2. Definite mild effect
3. Moderate strong drug effect
4. Very strong drug effect Thus a higher rank means a stronger drug effect and a lower rank a lesser drug effect
Measured: 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?"
EDQ question number 7," What would you be willing to pay for today's drug?"
Measured: 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)
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
Measured: 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)
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
Measured: DEQ was assessed at the 10 time points (predose through 9 hours)
Observer Rated Questionnaire 1) Maximum of Sedation/Sleepiness
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
Measured: ORQ was assessed at the 10 time points (predose through 9 hours)
Observer Rated Questionnaire 2) Maximum of Muscle Relaxation Locomotor
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
Measured: ORQ was assessed at the 10 time points (predose through 9 hours)
Observer Rated Questionnaire 3) Maximum of Muscle Relaxation Non-locomotor
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
Measured: ORQ was assessed at the 10 time points (predose through 9 hours)
Observer Rated Questionnaire 4) Maximum of Muscle Relaxation Posture
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
Measured: ORQ was assessed at the 10 time points (predose through 9 hours)
Observer Rated Questionnaire 5) Maximum of Speech
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
Measured: ORQ was assessed at the 10 time points (predose through 9 hours)
Observer Rated Questionnaire 6) Maximum of Confusion/Disorientation
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
Measured: ORQ was assessed at the 10 time points (predose through 9 hours)
Observer Rated Questionnaire 7) Maximum of Stimulation/Arousal
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
Measured: ORQ was assessed at the 10 time points (predose through 9 hours)
Observer Rated Questionnaire 8) Maximum of Drug Strength
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
Measured: ORQ was assessed at the 10 time points (predose through 9 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Jan 2009

First posted29 Jan 2008 (estimated)
Study startJan 2008
Primary completionJan 2009
Study completionJan 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Abuse Liability of Staccato AlprazolamStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
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
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00603980
Sponsor's protocol ID: AMDC-002-102
Other IDs: 22 January 2008
Status last verified: Jan 2009
First submitted: 17 Jan 2008
Last updated: 22 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com

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.
PubMed 25199955

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Abuse Liability Study of Staccato® Alprazolam for Inhalation in Subjects With Histories of Sedative Abuse
ClinicalTrials.gov ID: NCT00603980
Acronym / sponsor ID: AMDC-002-102
Conditions: Abuse Liability of Staccato Alprazolam
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Nova Pneuma Inc.Industry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 29 Jan 2008 (estimated)
Results: Posted 2 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 14
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

Arm	Type	Receives
Treatment sequence 1	Other	Drug: 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 sessionSequence 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
Treatment sequence 2	Other	Drug: 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 sessionSequence 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
Treatment sequence 3	Other	Drug: 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 sessionSequence 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
Treatment sequence 4	Other	Drug: 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 sessionSequence 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
Treatment sequence 5	Other	Drug: 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 sessionSequence 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
Treatment sequence 6	Other	Drug: 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 sessionSequence 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
Treatment sequence 7	Other	Drug: 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 sessionSequence 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
Treatment sequence 8	Other	Drug: 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 sessionSequence 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
Treatment sequence 9	Other	Drug: 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 sessionSequence 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
Treatment sequence 10	Other	Drug: 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 sessionSequence 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
Treatment sequence 11	Other	Drug: 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 sessionSequence 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
Treatment sequence 12	Other	Drug: 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 sessionSequence 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
Treatment sequence 13	Other	Drug: 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 sessionSequence 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
Treatment sequence 14	Other	Drug: 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 sessionSequence 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

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

Subjects with a significant current psychiatric illness or taking any psychotropic prescription medications for therapeutic uses.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Inhaled placebo + oral placeboInhaled Staccato placebo + oral placebo	Drug	Treatment sequence 1, Treatment sequence 10, Treatment sequence 11, Treatment sequence 12, Treatment sequence 13, Treatment sequence 14, Treatment sequence 2, Treatment sequence 3, Treatment sequence 4, Treatment sequence 5, Treatment sequence 6, Treatment sequence 7, Treatment sequence 8, Treatment sequence 9
Inhaled alprazolam 0.5 mgInhaled Staccato alprazolam 0.5 mg + oral placebo	Drug	Treatment sequence 1, Treatment sequence 10, Treatment sequence 11, Treatment sequence 12, Treatment sequence 13, Treatment sequence 14, Treatment sequence 2, Treatment sequence 3, Treatment sequence 4, Treatment sequence 5, Treatment sequence 6, Treatment sequence 7, Treatment sequence 8, Treatment sequence 9
Inhaled alprazolam 1 mgInhaled Staccato alprazolam 1 mg + oral placebo	Drug	Treatment sequence 1, Treatment sequence 10, Treatment sequence 11, Treatment sequence 12, Treatment sequence 13, Treatment sequence 14, Treatment sequence 2, Treatment sequence 3, Treatment sequence 4, Treatment sequence 5, Treatment sequence 6, Treatment sequence 7, Treatment sequence 8, Treatment sequence 9
Inhaled alprazolam 2 mgInhaled Staccato alprazolam 2 mg + oral placebo	Drug	Treatment sequence 1, Treatment sequence 10, Treatment sequence 11, Treatment sequence 12, Treatment sequence 13, Treatment sequence 14, Treatment sequence 2, Treatment sequence 3, Treatment sequence 4, Treatment sequence 5, Treatment sequence 6, Treatment sequence 7, Treatment sequence 8, Treatment sequence 9
Oral alprazolam 1 mgOral alprazolam 1 mg + Inhaled placebo	Drug	Treatment sequence 1, Treatment sequence 10, Treatment sequence 11, Treatment sequence 12, Treatment sequence 13, Treatment sequence 14, Treatment sequence 2, Treatment sequence 3, Treatment sequence 4, Treatment sequence 5, Treatment sequence 6, Treatment sequence 7, Treatment sequence 8, Treatment sequence 9
Oral alprazolam 2 mgOral alprazolam 2 mg + Inhaled placebo	Drug	Treatment sequence 1, Treatment sequence 10, Treatment sequence 11, Treatment sequence 12, Treatment sequence 13, Treatment sequence 14, Treatment sequence 2, Treatment sequence 3, Treatment sequence 4, Treatment sequence 5, Treatment sequence 6, Treatment sequence 7, Treatment sequence 8, Treatment sequence 9
Oral alprazolam 4 mOral alprazolam 4 mg + Inhaled placebo	Drug	Treatment sequence 1, Treatment sequence 10, Treatment sequence 11, Treatment sequence 12, Treatment sequence 13, Treatment sequence 14, Treatment sequence 2, Treatment sequence 3, Treatment sequence 4, Treatment sequence 5, Treatment sequence 6, Treatment sequence 7, Treatment sequence 8, Treatment sequence 9
Oral alprazolam 2 mg qualifying sessionQualifying session (2 mg oral alprazolam)	Drug	Treatment sequence 1, Treatment sequence 10, Treatment sequence 11, Treatment sequence 12, Treatment sequence 13, Treatment sequence 14, Treatment sequence 2, Treatment sequence 3, Treatment sequence 4, Treatment sequence 5, Treatment sequence 6, Treatment sequence 7, Treatment sequence 8, Treatment sequence 9
Oral placebo qualifying sessionQualifying control session (oral placebo)	Drug	Treatment sequence 1, Treatment sequence 10, Treatment sequence 11, Treatment sequence 12, Treatment sequence 13, Treatment sequence 14, Treatment sequence 2, Treatment sequence 3, Treatment sequence 4, Treatment sequence 5, Treatment sequence 6, Treatment sequence 7, Treatment sequence 8, Treatment sequence 9

Primary outcome

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

14 secondary outcomes

EDQ Question Number 2 "Rate Your Overall Liking of the Drug Effect"
Time frame: 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 1, "Rate the Overall Strength of the Drug Effect"
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?"
Time frame: 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)
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)
Observer Rated Questionnaire 1) Maximum of Sedation/Sleepiness
Time frame: 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)
Observer Rated Questionnaire 3) Maximum of Muscle Relaxation Non-locomotor
Time frame: 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)
Observer Rated Questionnaire 5) Maximum of Speech
Time frame: 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)
Observer Rated Questionnaire 7) Maximum of Stimulation/Arousal
Time frame: 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)

Results and safety

Results posted to the registry on 2 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Subjects Entering	31	15

Primary outcome: 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. Least squares mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 14	Oral Alprazolam 1 mg n = 14	Oral Alprazolam 2 mg n = 14	Oral Alprazolam 4 mg n = 14	Inhaled Alprazolam 0.5 mg n = 14	Inhaled Alprazolam 1 mg n = 14	Inhaled Alprazolam 2 mg n = 14
Value	0 (0.349)	1.714 (0.349)	2.143 (0.349)	2.286 (0.349)	1.00 (0.349)	1.714 (0.349)	2.214 (0.349)

Population analysed: Efficacy (crossover) Population, n=14. LSM \& SEM are based on all 14 subjects completing all 7 treatments. PROC MIXED model used assigns the same SEM to all 7 treatments.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Oral Alprazolam 1 mg	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Oral Alprazolam 2 mg	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Oral Alprazolam 4 mg	0 of 15 (0%)	1 of 15 (6.7%)	0 of 15
Inhaled Alprazolam 0.5 mg	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Inhaled Alprazolam 1 mg	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Inhaled Alprazolam 2 mg	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Qualifying Session 2 mg Oral	0 of 28 (0%)	0 of 28 (0%)	0 of 28
Qualifying Session Oral Placebo	0 of 28 (0%)	1 of 28 (3.6%)	0 of 28

Limitations and caveats (from the sponsor): A limitation of the current study was the lack of assessment of drug plasma levels. The differences in abuse potential measures may be due to differences in absorption, peak drug plasma levels, or other PK parameters

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25199955Reissig 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.
Individual participant dataSharing planned: Yes. IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Roland R Griffiths, PhD principal investigator

Johns Hopkins University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00603980, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.