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CompletedNCT00902772Updated Sep 23, 2009

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

A Phase 1 interventional study of Lorazepam and AZD7325 in Recreational CNS Depressant Use, sponsored by AstraZeneca. Completed at 1 site in Canada. Open to participants aged 18 Months to 55 Years. Per ClinicalTrials.gov, last updated 2009-09-23.

Sponsored by AstraZeneca · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Months to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Recreational CNS Depressant Use

Keywords

  • Recreational CNS depressant
  • Abuse liability
  • Abuse potential
  • Healthy Recreational CNS Depressant Users
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Months to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Placebo comparator
    A

    Placebo

    Drug: Placebo

  • Active comparator
    B

    Lorazepam

    Drug: Lorazepam

  • Active comparator
    C

    Lorazepam

    Drug: Lorazepam

  • Active comparator
    D

    Lorazepam

    Drug: Lorazepam

  • Experimental
    E

    AZD7325

    Drug: AZD7325

  • Experimental
    F

    AZD7325

    Drug: AZD7325

  • Experimental
    G

    AZD7325

    Drug: AZD7325

Interventions

  • DrugLorazepam

    mg, oral dose

  • DrugAZD7325

    mg, oral dose

  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Visual Analog Scales

    Time frame: Daily during Visit 2 through 9

Secondary outcomes

  1. Columbia Suicide-Severity Rating Scale

    Time frame: Prior to each treatment period

07

Study locations

1 site
  • Research Site
    Toronto, Ontario, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00902772
Lead sponsor
AstraZeneca
First posted
May 15, 2009
Start date
May 2009
Completion
Sep 2009
Last update
Sep 23, 2009

Study contacts

Myroslava K Romach, MD
principal investigator · Kendle Early Stage - Toronto

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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