Compare the abuse liabilities of Staccato Alprazolam, oral immediate-release alprazolam, and Staccato Placebo.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
31
Inhaled Staccato placebo + oral placebo
Inhaled Staccato alprazolam 0.5 mg + oral placebo
Inhaled Staccato alprazolam 1 mg + oral placebo
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
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
Time frame: End of day for each of the 7 crossover treatments
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
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".
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".
Time frame: 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
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Inhaled Staccato alprazolam 2 mg + oral placebo
Oral alprazolam 1 mg + Inhaled placebo
Oral alprazolam 2 mg + Inhaled placebo
Oral alprazolam 4 mg + Inhaled placebo
Qualifying session (2 mg oral alprazolam)
Qualifying control session (oral placebo)
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?"
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)
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
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)
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: ORQ was assessed at the 10 time points (predose through 9 hours)