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临床试验/NCT00603980
NCT00603980已完成1 期

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

Nova Pneuma Inc.1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2008年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
31
试验地点
1
主要终点
Response to EDQ Question Number 5, "Rate the Degree to Which You Would Like to Take the Drug Again"

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

In order to reduce discrimination between placebo and active Staccato Alprazolam, taste blinding will be accomplished using a rapidly dissolving, intensely flavored product (candy, strip or breath spray). The product will be administered immediately after each oral capsule dosing (at the -60-min and 0- min time points).

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

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

研究组 & 干预措施

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

干预措施: Inhaled alprazolam 1 mg (Drug)

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

干预措施: Oral alprazolam 2 mg qualifying session (Drug)

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

干预措施: Oral placebo qualifying session (Drug)

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

干预措施: Inhaled placebo + oral placebo (Drug)

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

干预措施: Inhaled alprazolam 0.5 mg (Drug)

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

干预措施: Inhaled alprazolam 1 mg (Drug)

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

干预措施: Oral alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 4 m (Drug)

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

干预措施: Inhaled alprazolam 1 mg (Drug)

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

干预措施: Inhaled alprazolam 0.5 mg (Drug)

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

干预措施: Inhaled placebo + oral placebo (Drug)

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

干预措施: Inhaled alprazolam 0.5 mg (Drug)

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

干预措施: Inhaled alprazolam 1 mg (Drug)

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

干预措施: Inhaled alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 1 mg (Drug)

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

干预措施: Oral alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 4 m (Drug)

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

干预措施: Oral alprazolam 2 mg qualifying session (Drug)

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

干预措施: Oral placebo qualifying session (Drug)

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

干预措施: Inhaled placebo + oral placebo (Drug)

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

干预措施: Inhaled alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 1 mg (Drug)

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

干预措施: Oral alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 4 m (Drug)

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

干预措施: Oral alprazolam 2 mg qualifying session (Drug)

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

干预措施: Oral placebo qualifying session (Drug)

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

干预措施: Inhaled placebo + oral placebo (Drug)

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

干预措施: Inhaled alprazolam 0.5 mg (Drug)

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

干预措施: Inhaled alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 1 mg (Drug)

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

干预措施: Oral alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 4 m (Drug)

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

干预措施: Oral alprazolam 2 mg qualifying session (Drug)

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

干预措施: Oral placebo qualifying session (Drug)

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

干预措施: Inhaled placebo + oral placebo (Drug)

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

干预措施: Inhaled alprazolam 0.5 mg (Drug)

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

干预措施: Inhaled alprazolam 1 mg (Drug)

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

干预措施: Inhaled alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 1 mg (Drug)

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

干预措施: Oral alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 4 m (Drug)

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

干预措施: Oral alprazolam 2 mg qualifying session (Drug)

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

干预措施: Oral placebo qualifying session (Drug)

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

干预措施: Inhaled placebo + oral placebo (Drug)

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

干预措施: Inhaled alprazolam 0.5 mg (Drug)

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

干预措施: Inhaled alprazolam 1 mg (Drug)

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

干预措施: Inhaled alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 1 mg (Drug)

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

干预措施: Oral alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 4 m (Drug)

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

干预措施: Oral alprazolam 2 mg qualifying session (Drug)

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

干预措施: Oral placebo qualifying session (Drug)

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

干预措施: Inhaled placebo + oral placebo (Drug)

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

干预措施: Inhaled alprazolam 0.5 mg (Drug)

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

干预措施: Inhaled alprazolam 1 mg (Drug)

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

干预措施: Inhaled alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 1 mg (Drug)

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

干预措施: Oral alprazolam 2 mg qualifying session (Drug)

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

干预措施: Oral placebo qualifying session (Drug)

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

干预措施: Inhaled placebo + oral placebo (Drug)

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

干预措施: Inhaled alprazolam 0.5 mg (Drug)

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

干预措施: Inhaled alprazolam 1 mg (Drug)

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

干预措施: Inhaled alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 1 mg (Drug)

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

干预措施: Oral alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 4 m (Drug)

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

干预措施: Inhaled alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 4 m (Drug)

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

干预措施: Oral alprazolam 2 mg qualifying session (Drug)

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

干预措施: Oral alprazolam 1 mg (Drug)

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

干预措施: Oral alprazolam 2 mg (Drug)

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

干预措施: Oral placebo qualifying session (Drug)

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

干预措施: Inhaled placebo + oral placebo (Drug)

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

干预措施: Inhaled alprazolam 0.5 mg (Drug)

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

干预措施: Inhaled alprazolam 1 mg (Drug)

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

干预措施: Inhaled alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 1 mg (Drug)

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

干预措施: Oral alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 4 m (Drug)

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

干预措施: Oral alprazolam 2 mg qualifying session (Drug)

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

干预措施: Oral placebo qualifying session (Drug)

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

干预措施: Inhaled placebo + oral placebo (Drug)

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

干预措施: Inhaled alprazolam 0.5 mg (Drug)

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

干预措施: Inhaled alprazolam 1 mg (Drug)

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

干预措施: Inhaled alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 1 mg (Drug)

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

干预措施: Oral alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 4 m (Drug)

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

干预措施: Oral alprazolam 2 mg qualifying session (Drug)

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

干预措施: Oral placebo qualifying session (Drug)

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

干预措施: Inhaled placebo + oral placebo (Drug)

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

干预措施: Inhaled alprazolam 0.5 mg (Drug)

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

干预措施: Inhaled alprazolam 1 mg (Drug)

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

干预措施: Inhaled alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 1 mg (Drug)

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

干预措施: Oral alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 4 m (Drug)

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

干预措施: Oral alprazolam 2 mg qualifying session (Drug)

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

干预措施: Oral placebo qualifying session (Drug)

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

干预措施: Inhaled placebo + oral placebo (Drug)

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

干预措施: Inhaled alprazolam 2 mg (Drug)

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

干预措施: Inhaled alprazolam 0.5 mg (Drug)

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

干预措施: Inhaled alprazolam 1 mg (Drug)

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

干预措施: Inhaled alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 1 mg (Drug)

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

干预措施: Oral alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 4 m (Drug)

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

干预措施: Oral alprazolam 2 mg qualifying session (Drug)

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

干预措施: Oral placebo qualifying session (Drug)

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

干预措施: Inhaled placebo + oral placebo (Drug)

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

干预措施: Inhaled alprazolam 0.5 mg (Drug)

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

干预措施: Inhaled alprazolam 1 mg (Drug)

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

干预措施: Oral alprazolam 1 mg (Drug)

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

干预措施: Oral alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 4 m (Drug)

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

干预措施: Oral alprazolam 2 mg qualifying session (Drug)

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

干预措施: Oral placebo qualifying session (Drug)

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

干预措施: Inhaled placebo + oral placebo (Drug)

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

干预措施: Inhaled alprazolam 0.5 mg (Drug)

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

干预措施: Inhaled alprazolam 1 mg (Drug)

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

干预措施: Inhaled alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 1 mg (Drug)

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

干预措施: Oral alprazolam 2 mg (Drug)

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

干预措施: Oral alprazolam 4 m (Drug)

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

干预措施: Oral alprazolam 2 mg qualifying session (Drug)

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

干预措施: Oral placebo qualifying session (Drug)

结局指标

主要结局

Response to EDQ Question Number 5, "Rate the Degree to Which You Would Like to Take the Drug Again"

时间窗: 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

次要结局

  • Maximum of DEQ Question 2 "Rate Your Liking of the Drug Effect" at the 10 Time Points (Predose Through 9 Hours)(DEQ was assessed at the 10 time points (predose through 9 hours))
  • EDQ Question Number 6 " 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 2 "Rate Your Overall Liking of the Drug Effect"(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)(DEQ was assessed at the 10 time points (predose through 9 hours))
  • Observer Rated Questionnaire 2) Maximum of Muscle Relaxation Locomotor(ORQ was assessed at the 10 time points (predose through 9 hours))
  • Observer Rated Questionnaire 3) Maximum of Muscle Relaxation Non-locomotor(ORQ was assessed at the 10 time points (predose through 9 hours))
  • Observer Rated Questionnaire 4) Maximum of Muscle Relaxation Posture(ORQ was assessed at the 10 time points (predose through 9 hours))
  • EDQ Question Number 1, "Rate the Overall Strength of the 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?"(End of day for each of the 7 crossover treatments)
  • Observer Rated Questionnaire 1) Maximum of Sedation/Sleepiness(ORQ was assessed at the 10 time points (predose through 9 hours))
  • Observer Rated Questionnaire 5) Maximum of Speech(ORQ was assessed at the 10 time points (predose through 9 hours))
  • Observer Rated Questionnaire 6) Maximum of Confusion/Disorientation(ORQ was assessed at the 10 time points (predose through 9 hours))
  • Observer Rated Questionnaire 7) Maximum of Stimulation/Arousal(ORQ was assessed at the 10 time points (predose through 9 hours))
  • Observer Rated Questionnaire 8) Maximum of Drug Strength(ORQ was assessed at the 10 time points (predose through 9 hours))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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