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OpenTrials
Completed

NCT Number: NCT00902772

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

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

Completed

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Key information

Conditions

Recreational CNS Depressant Use

Age range

18 month–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Toronto, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lorazepam

Drug

mg, oral dose

AZD7325

Drug

mg, oral dose

Placebo

Drug

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Study completion
2009
First posted
May 15, 2009
Registry last updated
Sep 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.