Study to Evaluate the Abuse Potential of AZD7325 in Healt... | NCT00902772

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

NCT00902772

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Sep 23, 2009Estimated

Enrollment

100Estimated

Phase

Phase 1

Conditions

Recreational CNS Depressant Use

Interventions

Lorazepam
AZD7325
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Not provided

Completion Date

Sep 2009Actual

First Submitted Date

May 12, 2009

First Submission Date that Met QC Criteria

May 14, 2009

First Posted Date

May 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2009

Last Update Posted Date

Sep 23, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Placebo Comparator	Placebo	Drug: Placebo
B	Active Comparator	Lorazepam	Drug: Lorazepam
C	Active Comparator	Lorazepam	Drug: Lorazepam
D	Active Comparator	Lorazepam	Drug: Lorazepam
E	Experimental	AZD7325	Drug: AZD7325
F	Experimental	AZD7325	Drug: AZD7325
G	Experimental	AZD7325

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lorazepam	Drug	mg, oral dose	B C D
AZD7325

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual Analog Scales		Daily during Visit 2 through 9

Secondary Outcomes

Measure	Description	Time Frame
Columbia Suicide-Severity Rating Scale		Prior to each treatment period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Months

Maximum Age

55 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Myroslava K Romach, MD	Kendle Early Stage - Toronto	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Toronto	Ontario		Canada

Intervention Browse Module

MeSH Terms

ID	Term
D008140	Lorazepam
C576237	4-amino-8-(2-fluoro-6-methoxy-phenyl)-N-propylcinnoline-3-carboxamide

Ancestor Terms

ID	Term
D001570	Benzodiazepinones
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring

Browse Leaves

Not provided

Browse Branches

Not provided