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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00902772
First Posted: May 15, 2009
Last Update Posted: September 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
May 12, 2009
May 15, 2009
September 23, 2009
May 2009
Not Provided
Visual Analog Scales [ Time Frame: Daily during Visit 2 through 9 ]
Same as current
Complete list of historical versions of study NCT00902772 on ClinicalTrials.gov Archive Site
Columbia Suicide-Severity Rating Scale [ Time Frame: Prior to each treatment period ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Abuse Potential of AZD7325 in Healthy Recreational Central Nervous System (CNS) Depressant Users
A 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
The purpose of this study is to examine the abuse potential of AZD7325.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Recreational CNS Depressant Use
  • Drug: Lorazepam
    mg, oral dose
  • Drug: AZD7325
    mg, oral dose
  • Drug: Placebo
  • Placebo Comparator: A
    Placebo
    Intervention: Drug: Placebo
  • Active Comparator: B
    Lorazepam
    Intervention: Drug: Lorazepam
  • Active Comparator: C
    Lorazepam
    Intervention: Drug: Lorazepam
  • Active Comparator: D
    Lorazepam
    Intervention: Drug: Lorazepam
  • Experimental: E
    AZD7325
    Intervention: Drug: AZD7325
  • Experimental: F
    AZD7325
    Intervention: Drug: AZD7325
  • Experimental: G
    AZD7325
    Intervention: Drug: AZD7325
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2009
Not Provided

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
Sexes Eligible for Study: All
18 Months to 55 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00902772
D1140C00008
No
Not Provided
Not Provided
MSD, AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Myroslava K Romach, MD Kendle Early Stage - Toronto
AstraZeneca
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP