Abuse Liability of Staccato Alprazolam Clinical Trial
Official title:
Abuse Liability Study of Staccato® Alprazolam for Inhalation in Subjects With Histories of Sedative Abuse
| Verified date | January 2009 |
| Source | Alexza Pharmaceuticals, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Compare the abuse liabilities of Staccato Alprazolam, oral immediate-release alprazolam, and Staccato Placebo.
| Status | Completed |
| Enrollment | 31 |
| Est. completion date | January 2009 |
| Est. primary completion date | January 2009 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Johns Hopkins University School of Medicine | Baltimore | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| Alexza Pharmaceuticals, Inc. |
United States,
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 20 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | End of day for each of the 7 crossover treatments | |
| Secondary | 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 |
End of day for each of the 7 crossover treatments | |
| Secondary | 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". | End of day for each of the 7 crossover treatments | |
| Secondary | 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 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 | |
| Secondary | 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?" | End of day for each of the 7 crossover treatments | |
| Secondary | 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 |
DEQ was assessed at the 10 time points (predose through 9 hours) | |
| Secondary | 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 |
DEQ was assessed at the 10 time points (predose through 9 hours) | |
| Secondary | 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 |
ORQ was assessed at the 10 time points (predose through 9 hours) | |
| Secondary | 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 |
ORQ was assessed at the 10 time points (predose through 9 hours) | |
| Secondary | 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 |
ORQ was assessed at the 10 time points (predose through 9 hours) | |
| Secondary | 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 |
ORQ was assessed at the 10 time points (predose through 9 hours) | |
| Secondary | 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 |
ORQ was assessed at the 10 time points (predose through 9 hours) | |
| Secondary | 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 |
ORQ was assessed at the 10 time points (predose through 9 hours) | |
| Secondary | 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 |
ORQ was assessed at the 10 time points (predose through 9 hours) | |
| Secondary | 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 |
ORQ was assessed at the 10 time points (predose through 9 hours) |