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

Overview[ - collapse ][ - ]

Purpose The purpose of this study is to examine the abuse potential of AZD7325.
ConditionRecreational CNS Depressant Use
InterventionDrug: Lorazepam
Drug: AZD7325
Drug: Placebo
PhasePhase 1
SponsorAstraZeneca
Responsible PartyAstraZeneca
ClinicalTrials.gov IdentifierNCT00902772
First ReceivedMay 12, 2009
Last UpdatedSeptember 22, 2009
Last verifiedSeptember 2009

Tracking Information[ + expand ][ + ]

First Received DateMay 12, 2009
Last Updated DateSeptember 22, 2009
Start DateMay 2009
Estimated Primary Completion DateSeptember 2009
Current Primary Outcome MeasuresVisual Analog Scales [Time Frame: Daily during Visit 2 through 9] [Designated as safety issue: No]
Current Secondary Outcome MeasuresColumbia Suicide-Severity Rating Scale [Time Frame: Prior to each treatment period] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief TitleStudy to Evaluate the Abuse Potential of AZD7325 in Healthy Recreational Central Nervous System (CNS) Depressant Users
Official TitleA Single-Centre, Single-Dose, Double-Blind, Randomized, Placebo- and Active-Controlled Crossover Study to Evaluate the AbusePotential of AZD7325 in Healthy Recreational CNS Depressant Users
Brief Summary
The purpose of this study is to examine the abuse potential of AZD7325.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
ConditionRecreational CNS Depressant Use
InterventionDrug: Lorazepam
mg, oral dose
Drug: AZD7325
mg, oral dose
Drug: Placebo
Study Arm (s)
  • Placebo Comparator: A
    Placebo
  • Active Comparator: B
    Lorazepam
  • Active Comparator: C
    Lorazepam
  • Active Comparator: D
    Lorazepam
  • Experimental: E
    AZD7325
  • Experimental: F
    AZD7325
  • Experimental: G
    AZD7325

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment100
Estimated Completion DateSeptember 2009
Estimated Primary Completion DateNot Provided
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
GenderBoth
Ages18 Months
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesCanada

Administrative Information[ + expand ][ + ]

NCT Number NCT00902772
Other Study ID NumbersD1140C00008
Has Data Monitoring CommitteeNo
Information Provided ByAstraZeneca
Study SponsorAstraZeneca
CollaboratorsNot Provided
Investigators Principal Investigator: Myroslava K Romach, MD Kendle Early Stage - Toronto
Verification DateSeptember 2009

Locations[ + expand ][ + ]

Research Site
Toronto, Ontario, Canada