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

September 22, 2009 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 55 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: A
Placebo
Drug: Placebo
ACTIVE_COMPARATOR: B
Lorazepam
Drug: Lorazepam
mg, oral dose
ACTIVE_COMPARATOR: C
Lorazepam
Drug: Lorazepam
mg, oral dose
ACTIVE_COMPARATOR: D
Lorazepam
Drug: Lorazepam
mg, oral dose
EXPERIMENTAL: E
AZD7325
Drug: AZD7325
mg, oral dose
EXPERIMENTAL: F
AZD7325
Drug: AZD7325
mg, oral dose
EXPERIMENTAL: G
AZD7325
Drug: AZD7325
mg, oral dose

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Myroslava K Romach, MD, Kendle Early Stage - Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

May 12, 2009

First Submitted That Met QC Criteria

May 14, 2009

First Posted (ESTIMATE)

May 15, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 23, 2009

Last Update Submitted That Met QC Criteria

September 22, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1140C00008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Recreational CNS Depressant Use

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe