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Staccato Alprazolam Abuse Liability

NCT ID: NCT00603980

Last Updated: 2020-01-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-01-31

Brief Summary

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

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Detailed Description

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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

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Abuse Liability of Staccato Alprazolam

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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).

Study Groups

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Treatment sequence 1

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

Group Type OTHER

Inhaled placebo + oral placebo

Intervention Type DRUG

Inhaled Staccato placebo + oral placebo

Inhaled alprazolam 0.5 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 0.5 mg + oral placebo

Inhaled alprazolam 1 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 1 mg + oral placebo

Inhaled alprazolam 2 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 2 mg + oral placebo

Oral alprazolam 1 mg

Intervention Type DRUG

Oral alprazolam 1 mg + Inhaled placebo

Oral alprazolam 2 mg

Intervention Type DRUG

Oral alprazolam 2 mg + Inhaled placebo

Oral alprazolam 4 m

Intervention Type DRUG

Oral alprazolam 4 mg + Inhaled placebo

Oral alprazolam 2 mg qualifying session

Intervention Type DRUG

Qualifying session (2 mg oral alprazolam)

Oral placebo qualifying session

Intervention Type DRUG

Qualifying control session (oral placebo)

Treatment sequence 2

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

Group Type OTHER

Inhaled placebo + oral placebo

Intervention Type DRUG

Inhaled Staccato placebo + oral placebo

Inhaled alprazolam 0.5 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 0.5 mg + oral placebo

Inhaled alprazolam 1 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 1 mg + oral placebo

Inhaled alprazolam 2 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 2 mg + oral placebo

Oral alprazolam 1 mg

Intervention Type DRUG

Oral alprazolam 1 mg + Inhaled placebo

Oral alprazolam 2 mg

Intervention Type DRUG

Oral alprazolam 2 mg + Inhaled placebo

Oral alprazolam 4 m

Intervention Type DRUG

Oral alprazolam 4 mg + Inhaled placebo

Oral alprazolam 2 mg qualifying session

Intervention Type DRUG

Qualifying session (2 mg oral alprazolam)

Oral placebo qualifying session

Intervention Type DRUG

Qualifying control session (oral placebo)

Treatment sequence 3

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

Group Type OTHER

Inhaled placebo + oral placebo

Intervention Type DRUG

Inhaled Staccato placebo + oral placebo

Inhaled alprazolam 0.5 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 0.5 mg + oral placebo

Inhaled alprazolam 1 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 1 mg + oral placebo

Inhaled alprazolam 2 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 2 mg + oral placebo

Oral alprazolam 1 mg

Intervention Type DRUG

Oral alprazolam 1 mg + Inhaled placebo

Oral alprazolam 2 mg

Intervention Type DRUG

Oral alprazolam 2 mg + Inhaled placebo

Oral alprazolam 4 m

Intervention Type DRUG

Oral alprazolam 4 mg + Inhaled placebo

Oral alprazolam 2 mg qualifying session

Intervention Type DRUG

Qualifying session (2 mg oral alprazolam)

Oral placebo qualifying session

Intervention Type DRUG

Qualifying control session (oral placebo)

Treatment sequence 4

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

Group Type OTHER

Inhaled placebo + oral placebo

Intervention Type DRUG

Inhaled Staccato placebo + oral placebo

Inhaled alprazolam 0.5 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 0.5 mg + oral placebo

Inhaled alprazolam 1 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 1 mg + oral placebo

Inhaled alprazolam 2 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 2 mg + oral placebo

Oral alprazolam 1 mg

Intervention Type DRUG

Oral alprazolam 1 mg + Inhaled placebo

Oral alprazolam 2 mg

Intervention Type DRUG

Oral alprazolam 2 mg + Inhaled placebo

Oral alprazolam 4 m

Intervention Type DRUG

Oral alprazolam 4 mg + Inhaled placebo

Oral alprazolam 2 mg qualifying session

Intervention Type DRUG

Qualifying session (2 mg oral alprazolam)

Oral placebo qualifying session

Intervention Type DRUG

Qualifying control session (oral placebo)

Treatment sequence 5

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

Group Type OTHER

Inhaled placebo + oral placebo

Intervention Type DRUG

Inhaled Staccato placebo + oral placebo

Inhaled alprazolam 0.5 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 0.5 mg + oral placebo

Inhaled alprazolam 1 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 1 mg + oral placebo

Inhaled alprazolam 2 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 2 mg + oral placebo

Oral alprazolam 1 mg

Intervention Type DRUG

Oral alprazolam 1 mg + Inhaled placebo

Oral alprazolam 2 mg

Intervention Type DRUG

Oral alprazolam 2 mg + Inhaled placebo

Oral alprazolam 4 m

Intervention Type DRUG

Oral alprazolam 4 mg + Inhaled placebo

Oral alprazolam 2 mg qualifying session

Intervention Type DRUG

Qualifying session (2 mg oral alprazolam)

Oral placebo qualifying session

Intervention Type DRUG

Qualifying control session (oral placebo)

Treatment sequence 6

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

Group Type OTHER

Inhaled placebo + oral placebo

Intervention Type DRUG

Inhaled Staccato placebo + oral placebo

Inhaled alprazolam 0.5 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 0.5 mg + oral placebo

Inhaled alprazolam 1 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 1 mg + oral placebo

Inhaled alprazolam 2 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 2 mg + oral placebo

Oral alprazolam 1 mg

Intervention Type DRUG

Oral alprazolam 1 mg + Inhaled placebo

Oral alprazolam 2 mg

Intervention Type DRUG

Oral alprazolam 2 mg + Inhaled placebo

Oral alprazolam 4 m

Intervention Type DRUG

Oral alprazolam 4 mg + Inhaled placebo

Oral alprazolam 2 mg qualifying session

Intervention Type DRUG

Qualifying session (2 mg oral alprazolam)

Oral placebo qualifying session

Intervention Type DRUG

Qualifying control session (oral placebo)

Treatment sequence 7

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

Group Type OTHER

Inhaled placebo + oral placebo

Intervention Type DRUG

Inhaled Staccato placebo + oral placebo

Inhaled alprazolam 0.5 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 0.5 mg + oral placebo

Inhaled alprazolam 1 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 1 mg + oral placebo

Inhaled alprazolam 2 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 2 mg + oral placebo

Oral alprazolam 1 mg

Intervention Type DRUG

Oral alprazolam 1 mg + Inhaled placebo

Oral alprazolam 2 mg

Intervention Type DRUG

Oral alprazolam 2 mg + Inhaled placebo

Oral alprazolam 4 m

Intervention Type DRUG

Oral alprazolam 4 mg + Inhaled placebo

Oral alprazolam 2 mg qualifying session

Intervention Type DRUG

Qualifying session (2 mg oral alprazolam)

Oral placebo qualifying session

Intervention Type DRUG

Qualifying control session (oral placebo)

Treatment sequence 8

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

Group Type OTHER

Inhaled placebo + oral placebo

Intervention Type DRUG

Inhaled Staccato placebo + oral placebo

Inhaled alprazolam 0.5 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 0.5 mg + oral placebo

Inhaled alprazolam 1 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 1 mg + oral placebo

Inhaled alprazolam 2 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 2 mg + oral placebo

Oral alprazolam 1 mg

Intervention Type DRUG

Oral alprazolam 1 mg + Inhaled placebo

Oral alprazolam 2 mg

Intervention Type DRUG

Oral alprazolam 2 mg + Inhaled placebo

Oral alprazolam 4 m

Intervention Type DRUG

Oral alprazolam 4 mg + Inhaled placebo

Oral alprazolam 2 mg qualifying session

Intervention Type DRUG

Qualifying session (2 mg oral alprazolam)

Oral placebo qualifying session

Intervention Type DRUG

Qualifying control session (oral placebo)

Treatment sequence 9

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

Group Type OTHER

Inhaled placebo + oral placebo

Intervention Type DRUG

Inhaled Staccato placebo + oral placebo

Inhaled alprazolam 0.5 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 0.5 mg + oral placebo

Inhaled alprazolam 1 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 1 mg + oral placebo

Inhaled alprazolam 2 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 2 mg + oral placebo

Oral alprazolam 1 mg

Intervention Type DRUG

Oral alprazolam 1 mg + Inhaled placebo

Oral alprazolam 2 mg

Intervention Type DRUG

Oral alprazolam 2 mg + Inhaled placebo

Oral alprazolam 4 m

Intervention Type DRUG

Oral alprazolam 4 mg + Inhaled placebo

Oral alprazolam 2 mg qualifying session

Intervention Type DRUG

Qualifying session (2 mg oral alprazolam)

Oral placebo qualifying session

Intervention Type DRUG

Qualifying control session (oral placebo)

Treatment sequence 10

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

Group Type OTHER

Inhaled placebo + oral placebo

Intervention Type DRUG

Inhaled Staccato placebo + oral placebo

Inhaled alprazolam 0.5 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 0.5 mg + oral placebo

Inhaled alprazolam 1 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 1 mg + oral placebo

Inhaled alprazolam 2 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 2 mg + oral placebo

Oral alprazolam 1 mg

Intervention Type DRUG

Oral alprazolam 1 mg + Inhaled placebo

Oral alprazolam 2 mg

Intervention Type DRUG

Oral alprazolam 2 mg + Inhaled placebo

Oral alprazolam 4 m

Intervention Type DRUG

Oral alprazolam 4 mg + Inhaled placebo

Oral alprazolam 2 mg qualifying session

Intervention Type DRUG

Qualifying session (2 mg oral alprazolam)

Oral placebo qualifying session

Intervention Type DRUG

Qualifying control session (oral placebo)

Treatment sequence 11

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

Group Type OTHER

Inhaled placebo + oral placebo

Intervention Type DRUG

Inhaled Staccato placebo + oral placebo

Inhaled alprazolam 0.5 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 0.5 mg + oral placebo

Inhaled alprazolam 1 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 1 mg + oral placebo

Inhaled alprazolam 2 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 2 mg + oral placebo

Oral alprazolam 1 mg

Intervention Type DRUG

Oral alprazolam 1 mg + Inhaled placebo

Oral alprazolam 2 mg

Intervention Type DRUG

Oral alprazolam 2 mg + Inhaled placebo

Oral alprazolam 4 m

Intervention Type DRUG

Oral alprazolam 4 mg + Inhaled placebo

Oral alprazolam 2 mg qualifying session

Intervention Type DRUG

Qualifying session (2 mg oral alprazolam)

Oral placebo qualifying session

Intervention Type DRUG

Qualifying control session (oral placebo)

Treatment sequence 12

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

Group Type OTHER

Inhaled placebo + oral placebo

Intervention Type DRUG

Inhaled Staccato placebo + oral placebo

Inhaled alprazolam 0.5 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 0.5 mg + oral placebo

Inhaled alprazolam 1 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 1 mg + oral placebo

Inhaled alprazolam 2 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 2 mg + oral placebo

Oral alprazolam 1 mg

Intervention Type DRUG

Oral alprazolam 1 mg + Inhaled placebo

Oral alprazolam 2 mg

Intervention Type DRUG

Oral alprazolam 2 mg + Inhaled placebo

Oral alprazolam 4 m

Intervention Type DRUG

Oral alprazolam 4 mg + Inhaled placebo

Oral alprazolam 2 mg qualifying session

Intervention Type DRUG

Qualifying session (2 mg oral alprazolam)

Oral placebo qualifying session

Intervention Type DRUG

Qualifying control session (oral placebo)

Treatment sequence 13

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

Group Type OTHER

Inhaled placebo + oral placebo

Intervention Type DRUG

Inhaled Staccato placebo + oral placebo

Inhaled alprazolam 0.5 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 0.5 mg + oral placebo

Inhaled alprazolam 1 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 1 mg + oral placebo

Inhaled alprazolam 2 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 2 mg + oral placebo

Oral alprazolam 1 mg

Intervention Type DRUG

Oral alprazolam 1 mg + Inhaled placebo

Oral alprazolam 2 mg

Intervention Type DRUG

Oral alprazolam 2 mg + Inhaled placebo

Oral alprazolam 4 m

Intervention Type DRUG

Oral alprazolam 4 mg + Inhaled placebo

Oral alprazolam 2 mg qualifying session

Intervention Type DRUG

Qualifying session (2 mg oral alprazolam)

Oral placebo qualifying session

Intervention Type DRUG

Qualifying control session (oral placebo)

Treatment sequence 14

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

Group Type OTHER

Inhaled placebo + oral placebo

Intervention Type DRUG

Inhaled Staccato placebo + oral placebo

Inhaled alprazolam 0.5 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 0.5 mg + oral placebo

Inhaled alprazolam 1 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 1 mg + oral placebo

Inhaled alprazolam 2 mg

Intervention Type DRUG

Inhaled Staccato alprazolam 2 mg + oral placebo

Oral alprazolam 1 mg

Intervention Type DRUG

Oral alprazolam 1 mg + Inhaled placebo

Oral alprazolam 2 mg

Intervention Type DRUG

Oral alprazolam 2 mg + Inhaled placebo

Oral alprazolam 4 m

Intervention Type DRUG

Oral alprazolam 4 mg + Inhaled placebo

Oral alprazolam 2 mg qualifying session

Intervention Type DRUG

Qualifying session (2 mg oral alprazolam)

Oral placebo qualifying session

Intervention Type DRUG

Qualifying control session (oral placebo)

Interventions

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Inhaled placebo + oral placebo

Inhaled Staccato placebo + oral placebo

Intervention Type DRUG

Inhaled alprazolam 0.5 mg

Inhaled Staccato alprazolam 0.5 mg + oral placebo

Intervention Type DRUG

Inhaled alprazolam 1 mg

Inhaled Staccato alprazolam 1 mg + oral placebo

Intervention Type DRUG

Inhaled alprazolam 2 mg

Inhaled Staccato alprazolam 2 mg + oral placebo

Intervention Type DRUG

Oral alprazolam 1 mg

Oral alprazolam 1 mg + Inhaled placebo

Intervention Type DRUG

Oral alprazolam 2 mg

Oral alprazolam 2 mg + Inhaled placebo

Intervention Type DRUG

Oral alprazolam 4 m

Oral alprazolam 4 mg + Inhaled placebo

Intervention Type DRUG

Oral alprazolam 2 mg qualifying session

Qualifying session (2 mg oral alprazolam)

Intervention Type DRUG

Oral placebo qualifying session

Qualifying control session (oral placebo)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alexza Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roland R Griffiths, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 25199955 (View on PubMed)

Other Identifiers

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22 January 2008

Identifier Type: -

Identifier Source: secondary_id

AMDC-002-102

Identifier Type: -

Identifier Source: org_study_id

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Effects of Intranasal Oxytocin in the Treatment of Benzodiazepine Withdrawal: A Pilot RCT
NCT06757517 RECRUITING PHASE2
Opiates and Benzodiazepines on Driving
NCT03447353 COMPLETED PHASE4
Lorazepam-Induced Toxicity in the Aged
NCT00044642 COMPLETED PHASE4
Brief Motivational Intervention (BMI) on the Deprescription of Benzodiazepines and Related Substances in Adult Chronic Drug Users
NCT06446349 RECRUITING NA
Lack of Acute Tolerance Development to Effects of Nitrous Oxide - 4
NCT00000252 COMPLETED PHASE2
Benzodiazepines for the Reduction of Distress and Pain During and After Emergency Department Care
NCT03756038 TERMINATED PHASE2
Placebo Controlled Study of Sublingual Salvinorin A
NCT01149824 COMPLETED NA
Single Ascending Dose Study With BPL-003 in Healthy Subjects
NCT05347849 COMPLETED PHASE1
Opioid/Benzodiazepine Polydrug Abuse
NCT03696017 RECRUITING
The Effects of ∆-9-THC and Naloxone in Humans
NCT01591629 COMPLETED EARLY_PHASE1
HARM REDUCTION INTERVENTION FOR PEOPLE WHO USE ANABOLIC ANDROGENIC STEROIDS: THE RANDOMIZED CONTROLLED TRIAL
NCT07039539 NOT_YET_RECRUITING NA
Naltrexone in Borderline Personality Disorder
NCT00124839 TERMINATED PHASE3
Substance Misuse To Psychosis for Ketamine (SToP-K)
NCT03485339 COMPLETED
Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study
NCT06335407 RECRUITING PHASE1