Study to Evaluate the Abuse Potential of AZD7325 in Healthy Recreational Central Nervous System (CNS) Depressant Users

NCT ID: NCT00902772

Last Updated: 2009-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-09-30

Brief Summary

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The purpose of this study is to examine the abuse potential of AZD7325.

Detailed Description

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Conditions

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Recreational CNS Depressant Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

B

Lorazepam

Group Type ACTIVE_COMPARATOR

Lorazepam

Intervention Type DRUG

mg, oral dose

C

Lorazepam

Group Type ACTIVE_COMPARATOR

Lorazepam

Intervention Type DRUG

mg, oral dose

D

Lorazepam

Group Type ACTIVE_COMPARATOR

Lorazepam

Intervention Type DRUG

mg, oral dose

E

AZD7325

Group Type EXPERIMENTAL

AZD7325

Intervention Type DRUG

mg, oral dose

F

AZD7325

Group Type EXPERIMENTAL

AZD7325

Intervention Type DRUG

mg, oral dose

G

AZD7325

Group Type EXPERIMENTAL

AZD7325

Intervention Type DRUG

mg, oral dose

Interventions

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Lorazepam

mg, oral dose

Intervention Type DRUG

AZD7325

mg, oral dose

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Recreational CNS depressant use, defined as at least 10 lifetime occasions of non-medical use of drugs with depressant/sedative properties and at least 1 non-medical use in the year prior to screening
* Body mass index (BMI) within the range of 19.0 to 33.0 kg/m2, inclusive, and a minimum weight of 50.0 kg at screening
* Willing and able to abide by all study requirements and restrictions

Exclusion Criteria

* Unwillingness of inability to abstain from recreational drug use for the duration of the study from screening until follow-up
* Positive breath alcohol test prior to dosing
* Clinically significant abnormalities on physical examination, medical history, 12-lead ECG, vital signs, or safety laboratories
Minimum Eligible Age

18 Months

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Myroslava K Romach, MD

Role: PRINCIPAL_INVESTIGATOR

Kendle Early Stage - Toronto

Locations

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Research Site

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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D1140C00008

Identifier Type: -

Identifier Source: org_study_id

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