Staccato Alprazolam Abuse Liability
Status and phase
Completed
Phase 1
Conditions
Abuse Liability of Staccato Alprazolam
Treatments
Drug: Oral alprazolam 1 mg
Drug: Oral alprazolam 4 m
Drug: Inhaled placebo + oral placebo
Drug: Oral alprazolam 2 mg qualifying session
Drug: Inhaled alprazolam 1 mg
Drug: Inhaled alprazolam 2 mg
Drug: Oral placebo qualifying session
Drug: Inhaled alprazolam 0.5 mg
Drug: Oral alprazolam 2 mg
Details and patient eligibility
About
Compare the abuse liabilities of Staccato Alprazolam, oral immediate-release alprazolam, and Staccato Placebo.
Full 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.
Enrollment
31 patients
Sex
All
Ages
18 to 55 years old
Volunteers
Accepts Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Quadruple Blind
31 participants in 14 patient groups
Treatment sequence 1
Other group
Description:
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
Treatment:
Drug: Inhaled alprazolam 2 mg
Drug: Inhaled placebo + oral placebo
Drug: Oral placebo qualifying session
Drug: Oral alprazolam 2 mg
Drug: Oral alprazolam 1 mg
Drug: Oral alprazolam 4 m
Drug: Oral alprazolam 2 mg qualifying session
Drug: Inhaled alprazolam 1 mg
Drug: Inhaled alprazolam 0.5 mg
Treatment sequence 2
Other group
Description:
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
Treatment:
Drug: Inhaled alprazolam 2 mg
Drug: Inhaled placebo + oral placebo
Drug: Oral placebo qualifying session
Drug: Oral alprazolam 2 mg
Drug: Oral alprazolam 1 mg
Drug: Oral alprazolam 4 m
Drug: Oral alprazolam 2 mg qualifying session
Drug: Inhaled alprazolam 1 mg
Drug: Inhaled alprazolam 0.5 mg
Treatment sequence 3
Other group
Description:
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
Treatment:
Drug: Inhaled alprazolam 2 mg
Drug: Inhaled placebo + oral placebo
Drug: Oral placebo qualifying session
Drug: Oral alprazolam 2 mg
Drug: Oral alprazolam 1 mg
Drug: Oral alprazolam 4 m
Drug: Oral alprazolam 2 mg qualifying session
Drug: Inhaled alprazolam 1 mg
Drug: Inhaled alprazolam 0.5 mg
Treatment sequence 4
Other group
Description:
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
Treatment:
Drug: Inhaled alprazolam 2 mg
Drug: Inhaled placebo + oral placebo
Drug: Oral placebo qualifying session
Drug: Oral alprazolam 2 mg
Drug: Oral alprazolam 1 mg
Drug: Oral alprazolam 4 m
Drug: Oral alprazolam 2 mg qualifying session
Drug: Inhaled alprazolam 1 mg
Drug: Inhaled alprazolam 0.5 mg
Treatment sequence 5
Other group
Description:
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
Treatment:
Drug: Inhaled alprazolam 2 mg
Drug: Inhaled placebo + oral placebo
Drug: Oral placebo qualifying session
Drug: Oral alprazolam 2 mg
Drug: Oral alprazolam 1 mg
Drug: Oral alprazolam 4 m
Drug: Oral alprazolam 2 mg qualifying session
Drug: Inhaled alprazolam 1 mg
Drug: Inhaled alprazolam 0.5 mg
Treatment sequence 6
Other group
Description:
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
Treatment:
Drug: Inhaled alprazolam 2 mg
Drug: Inhaled placebo + oral placebo
Drug: Oral placebo qualifying session
Drug: Oral alprazolam 2 mg
Drug: Oral alprazolam 1 mg
Drug: Oral alprazolam 4 m
Drug: Oral alprazolam 2 mg qualifying session
Drug: Inhaled alprazolam 1 mg
Drug: Inhaled alprazolam 0.5 mg
Treatment sequence 7
Other group
Description:
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
Treatment:
Drug: Inhaled alprazolam 2 mg
Drug: Inhaled placebo + oral placebo
Drug: Oral placebo qualifying session
Drug: Oral alprazolam 2 mg
Drug: Oral alprazolam 1 mg
Drug: Oral alprazolam 4 m
Drug: Oral alprazolam 2 mg qualifying session
Drug: Inhaled alprazolam 1 mg
Drug: Inhaled alprazolam 0.5 mg
Treatment sequence 8
Other group
Description:
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
Treatment:
Drug: Inhaled alprazolam 2 mg
Drug: Inhaled placebo + oral placebo
Drug: Oral placebo qualifying session
Drug: Oral alprazolam 2 mg
Drug: Oral alprazolam 1 mg
Drug: Oral alprazolam 4 m
Drug: Oral alprazolam 2 mg qualifying session
Drug: Inhaled alprazolam 1 mg
Drug: Inhaled alprazolam 0.5 mg
Treatment sequence 9
Other group
Description:
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
Treatment:
Drug: Inhaled alprazolam 2 mg
Drug: Inhaled placebo + oral placebo
Drug: Oral placebo qualifying session
Drug: Oral alprazolam 2 mg
Drug: Oral alprazolam 1 mg
Drug: Oral alprazolam 4 m
Drug: Oral alprazolam 2 mg qualifying session
Drug: Inhaled alprazolam 1 mg
Drug: Inhaled alprazolam 0.5 mg
Treatment sequence 10
Other group
Description:
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
Treatment:
Drug: Inhaled alprazolam 2 mg
Drug: Inhaled placebo + oral placebo
Drug: Oral placebo qualifying session
Drug: Oral alprazolam 2 mg
Drug: Oral alprazolam 1 mg
Drug: Oral alprazolam 4 m
Drug: Oral alprazolam 2 mg qualifying session
Drug: Inhaled alprazolam 1 mg
Drug: Inhaled alprazolam 0.5 mg
Treatment sequence 11
Other group
Description:
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
Treatment:
Drug: Inhaled alprazolam 2 mg
Drug: Inhaled placebo + oral placebo
Drug: Oral placebo qualifying session
Drug: Oral alprazolam 2 mg
Drug: Oral alprazolam 1 mg
Drug: Oral alprazolam 4 m
Drug: Oral alprazolam 2 mg qualifying session
Drug: Inhaled alprazolam 1 mg
Drug: Inhaled alprazolam 0.5 mg
Treatment sequence 12
Other group
Description:
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
Treatment:
Drug: Inhaled alprazolam 2 mg
Drug: Inhaled placebo + oral placebo
Drug: Oral placebo qualifying session
Drug: Oral alprazolam 2 mg
Drug: Oral alprazolam 1 mg
Drug: Oral alprazolam 4 m
Drug: Oral alprazolam 2 mg qualifying session
Drug: Inhaled alprazolam 1 mg
Drug: Inhaled alprazolam 0.5 mg
Treatment sequence 13
Other group
Description:
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
Treatment:
Drug: Inhaled alprazolam 2 mg
Drug: Inhaled placebo + oral placebo
Drug: Oral placebo qualifying session
Drug: Oral alprazolam 2 mg
Drug: Oral alprazolam 1 mg
Drug: Oral alprazolam 4 m
Drug: Oral alprazolam 2 mg qualifying session
Drug: Inhaled alprazolam 1 mg
Drug: Inhaled alprazolam 0.5 mg
Treatment sequence 14
Other group
Description:
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
Treatment:
Drug: Inhaled alprazolam 2 mg
Drug: Inhaled placebo + oral placebo
Drug: Oral placebo qualifying session
Drug: Oral alprazolam 2 mg
Drug: Oral alprazolam 1 mg
Drug: Oral alprazolam 4 m
Drug: Oral alprazolam 2 mg qualifying session
Drug: Inhaled alprazolam 1 mg
Drug: Inhaled alprazolam 0.5 mg
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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